Research ArticleArticle
Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis
Nicolino Ruperto, Hermine I. Brunner, Nikolay Tzaribachev, Gabriel Vega-Cornejo, Ingrid Louw, Rolando Cimaz, Jason Dare, Graciela Espada, Enrique Faugier, Manuel Ferrandiz, Valeria Gerloni, Pierre Quartier, Clovis Artur Silva, Linda Wagner-Weiner, Yash Gandhi, Julie Passarell, Marleen Nys, Robert Wong, Alberto Martini and Daniel J. Lovell for the Pediatric Rheumatology Collaborative Study Group (PRCSG), the Paediatric Rheumatology International Trials Organisation (PRINTO)
The Journal of Rheumatology January 2021, jrheum.200154; DOI: https://doi.org/10.3899/jrheum.200154
Nicolino Ruperto
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Hermine I. Brunner
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Nikolay Tzaribachev
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Gabriel Vega-Cornejo
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Ingrid Louw
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Rolando Cimaz
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Jason Dare
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Graciela Espada
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Enrique Faugier
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Manuel Ferrandiz
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Valeria Gerloni
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Pierre Quartier
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Clovis Artur Silva
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Linda Wagner-Weiner
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Yash Gandhi
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Julie Passarell
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Marleen Nys
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Robert Wong
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Alberto Martini
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
Daniel J. Lovell
This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published. N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy. N. Ruperto and H.I. Brunner contributed equally to the manuscript. NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties. HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL. Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org. Accepted for publication December 18, 2020.
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- Nicolino Ruperto,
- Hermine I. Brunner,
- Nikolay Tzaribachev,
- Gabriel Vega-Cornejo,
- Ingrid Louw,
- Rolando Cimaz,
- Jason Dare,
- Graciela Espada,
- Enrique Faugier,
- Manuel Ferrandiz,
- Valeria Gerloni,
- Pierre Quartier,
- Clovis Artur Silva,
- Linda Wagner-Weiner,
- Yash Gandhi,
- Julie Passarell,
- Marleen Nys,
- Robert Wong,
- Alberto Martini and
- Daniel J. Lovell; for the Pediatric Rheumatology Collaborative Study Group (PRCSG), the Paediatric Rheumatology International Trials Organisation (PRINTO)
- This study was funded by Bristol Myers Squibb. Professional medical writing and editorial assistance was provided by Lola Parfitt, MRes, at Caudex and was funded by Bristol Myers Squibb. The study was designed jointly by academic authors and Bristol Myers Squibb, with data collected by PRINTO/ PRCSG investigators. Consistency in reporting the study data to healthcare authorities and institutional review boards was ensured by Bristol Myers Squibb. All authors attest to the completeness and veracity of data and data analyses. All authors had full access to study data, reviewed and revised the manuscript, and approved the final version to be published.
N. Ruperto, MD, MPH, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia-UOSID Centro Trial, Genoa, Italy; H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA; N. Tzaribachev, MD, Pediatric Rheumatology Research Institute, Bad Bramstedt, Germany; G. Vega-Cornejo, MD, CREA Hospital México Americano, Guadalajara, Jalisco, Mexico; I. Louw, MMED, MBChB, Panorama Medical Centre, Cape Town, South Africa; R. Cimaz, MD, University Hospital Meyer, Florence, Italy and Department of Clinical Sciences and Community Health, University of Milano, Milan, Italy; J. Dare, MD, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA; G. Espada, MD, Hospital de Niños Dr Ricardo Gutiérrez, Buenos Aires, Argentina; E. Faugier, MD, Hospital Infantil de México Federico Gómez, Mexico City, Mexico; M. Ferrandiz, MD, Instituto Nacional de Salúd del Niño, Breña, Peru; V. Gerloni, MD, Istituto Ortopedico Gaetano Pini, Milan, Italy; P. Quartier, MD, Université de Paris, IMAGINE Institute, RAISE reference centre for rare diseases, Necker-Enfants Malades hospital, AP-HP, Paris, France; C.A. Silva, MD, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil; L. Wagner-Weiner, MD, MS, University of Chicago, Chicago, Illinois, USA; Y. Gandhi, PhD, R. Wong, MD, Bristol Myers Squibb, Princeton, New Jersey, USA; J. Passarell, MA, Cognigen Corporation, Buffalo, New York, USA; M. Nys, MSc, Bristol Myers Squibb, Braine-L’Alleud, Belgium; A. Martini, MD, IRCCS Istituto G Gaslini, Clinica Pediatrica e Reumatologia, Genoa, Italy and Università di Genova, Genoa, Italy.
N. Ruperto and H.I. Brunner contributed equally to the manuscript.
NR has received honoraria for consultancy or speakers’ bureaus from AbbVie, Ablynx, AstraZeneca, Biogen Idec, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, F. Hoffman-La Roche, GlaxoSmithKline, Janssen, Novartis, Pfizer, R-Pharm, Sanofi, Sinergie, Sobi, and Takeda. The Gaslini Hospital has received contributions from the following companies: Bristol Myers Squibb, F. Hoffman-La Roche, Janssen, Novartis, Pfizer, and Sobi. This money has been reinvested for the research activities of the hospital in a fully independent manner besides any commitment with third parties.
HIB has served on speakers bureaus for Genentech, GlaxoSmithKline, and Novartis. The Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, Eli Lilly, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of HIB. NT has nothing to declare. GVC has received consulting fees from AbbVie, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and UCB. IL has received consulting fees from Amgen, Janssen, Novartis, Pfizer, and Roche. RC has received consulting fees from or participated on speakers bureaus for AbbVie, Novartis, Sanofi, and Sobi. JD has received support for clinical trials/registries from AbbVie, AstraZeneca, Bristol Myers Squibb, Horizon Pharma, Medac, Pfizer, Roche, and UCB. GE has nothing to declare. EF has nothing to declare. MF has nothing to declare. VG has nothing to declare. PQ has received consulting fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sobi; has served on speakers bureaus for AbbVie, Bristol Myers Squibb, MedImmune, Novartis, Pfizer, Roche, and Sobi; has served on a safety monitoring board for Sanofi; has acted as a trial investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Novartis, Novimmune, Pfizer, Roche, and Sanofi; and has received congress financial support from AbbVie, Bristol Myers Squibb, Novartis, Pfizer, and Sobi. CAS has nothing to declare. LWW has nothing to declare. YG, MN, and RW are employees and shareholders of Bristol Myers Squibb. JP is an employee of Cognigen Corporation. AM has received consulting fees from Janssen, Novartis, and Pfizer; Istituto G Gaslini, Clinica Pediatrica e Reumatologia has received consulting fees from AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Novartis, Pfizer, and R-Pharm for the work of AM. DJL has served on speakers bureaus for Bristol Myers Squibb and Genentech; and has served on Data and Safety Monitoring Boards for Forest Research and the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. Cincinnati Children’s Hospital Medical Center has received consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb, Centocor, F. Hoffman La-Roche, Genentech, Novartis, Pfizer, Regeneron, UBC, and Xoma for the work of DJL.
Address correspondence to Dr. N. Ruperto, Istituto G. Gaslini Clinica Pediatria e Reumatologia-UOSID Centro Trial, PRINTO, EULAR Centre of Excellence in Rheumatology 2008-2023, Via Gaslini, 5, 16147 Genova, Italy. Email: nicolaruperto@gaslini.org.
Accepted for publication December 18, 2020.
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The Journal of Rheumatology Jan 2021, jrheum.200154; DOI: 10.3899/jrheum.200154