Research ArticleArticle
Open Access
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial
Filip Van den Bosch, James Cheng-Chung Wei, Peter Nash, Francisco J. Blanco, Daniela Graham, Chuanbo Zang, Edmund Arthur, Cecilia Borlenghi, Vassilis Tsekouras, Bonnie Vlahos and Atul Deodhar
The Journal of Rheumatology November 2022, jrheum.220353; DOI: https://doi.org/10.3899/jrheum.220353
Filip Van den Bosch
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
James Cheng-Chung Wei
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Peter Nash
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Francisco J. Blanco
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Daniela Graham
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Chuanbo Zang
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Edmund Arthur
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Cecilia Borlenghi
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Vassilis Tsekouras
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Bonnie Vlahos
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Atul Deodhar
This study was sponsored by Pfizer. F. Van den Bosch, MD, PhD, Department of Internal Medicine and Pediatrics, Ghent University, and VIB Center for Inflammation Research, Ghent, Belgium. J.C.C. Wei, MD, PhD, Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital, Institute of Medicine, College of Medicine, Chung Shan Medical University, and Graduate Institute of Integrated Medicine, China Medical University, Taichung, Taiwan. P. Nash, MD, Department of Medicine, Griffith University, Brisbane, Australia. F.J. Blanco, MD, PhD, Universidad de A Coruña, Grupo de Investigación de Reumatología (GIR), INIBIC – Complejo Hospitalario Universitario de A Coruña, SERGAS, Departamento de Fisioterapia y Medicina, A Coruña, Spain. D. Graham, MD, Global Product Development, Pfizer, Groton, Connecticut, USA. C. Zang, PhD, Global Biometrics and Data Management, Pfizer, Collegeville, Pennsylvania, USA. E. Arthur, PharmD, Clinical Development and Operations, Pfizer, Peapack, New Jersey, USA. C. Borlenghi, MD, Inflammation & Immunology, Pfizer Global Medical Affairs, Buenos Aires, Argentina. V. Tsekouras, MD, PhD, Inflammation & Immunology, Pfizer Global Medical Affairs, Strovolos, Cyprus. B. Vlahos, BSN, MBA, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA. A. Deodhar, MD, Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA. FVdB reports grant/research support from AbbVie, Merck, and UCB; and consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MoonLake, Novartis, Pfizer, and UCB. JCCW reports grant/ research support from AbbVie, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB; and consulting fees from TSH Biopharm, AbbVie, BMS, Celgene, Chugai, Eisai, Janssen, Novartis, Pfizer, Sanofi-Aventis, and UCB Pharma. PN reports grant/research support from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; reports consulting fees from AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis; and is on the speakers bureau for AbbVie, BMS, UCB, Lilly, Roche, Sanofi, Pfizer, Janssen, Gilead, and Novartis. FJB reports grant/ research support from Sanofi-Aventis, Lilly, BMS, Amgen, Pfizer, AbbVie, TRB Chemedica International, GSK, Archigen Biotech Limited, Novartis, Nichi-Iko Pharmaceutical, Genentech, Janssen Research & Development, UCB Biopharma, Centrexion Therapeutics, Celgene, Roche, Regeneron Pharmaceuticals, Biohope, Corbus Pharmaceutical, Tedec Meiji Pharma, Kiniksa Pharmaceuticals, and Gilead Sciences; and consulting fees from Lilly, BMS, Grunenthal, and Pfizer. DG, CZ, EA, CB, VT, and BV are employees of Pfizer and hold Pfizer stock. AD reports grant/research support from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB; and consulting fees from Amgen, AbbVie, Aurinia, BI, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB. Address correspondence to Dr. F. Van den Bosch, Universitair Ziekenhuis Gent – Dienst Reumatologie (University Hospital Ghent – Department of Rheumatology), Corneel Heymanslaan 10, B-9000 Ghent, Belgium. Email: filip.vandenbosch@ugent.be. Accepted for publication November 9, 2022.
Abstract
Objective RE-EMBARK investigated etanercept (ETN) withdrawal and retreatment in patients with nonradiographic axial spondyloarthritis (nr-axSpA) achieving inactive disease.
Methods Patients received ETN and a background nonsteroidal antiinflammatory drug for 24 weeks in period 1 (P1); those achieving inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] with C-reactive protein [CRP] < 1.3) discontinued ETN for 40 weeks or less (period 2 [P2]). Patients who flared (ASDAS with erythrocyte sedimentation rate [ESR] ≥ 2.1) were retreated for 12 weeks in period 3 (P3). The primary endpoint was the proportion of patients with inactive disease who flared within 40 weeks of ETN withdrawal. Baseline characteristics were analyzed post hoc as predictors of maintenance and regaining of inactive disease, respectively, using univariate logistic and stepwise multivariable logistic regression models.
Results The proportion of patients experiencing flare following ETN withdrawal (P2) increased from 22.3% (25/112) after 4 weeks to 67% (77/115) after 40 weeks; 74.8% (86/115) experienced flare at any time during P2. Median time to flare was 16.1 weeks. Most patients (54/87, 62.1%) who were retreated with ETN in P3 reachieved inactive disease. Absence of both sacroiliitis detected on magnetic resonance imaging (MRI) and high-sensitivity CRP (hs-CRP) > 3 mg/L at baseline predicted inactive disease maintenance in P2 following ETN withdrawal in multivariable analysis; male sex and age younger than 40 years predicted regaining of inactive disease in P3 after flare/retreatment. There were no unexpected safety signals.
Conclusion Approximately 25% of patients maintained inactive disease for 40 weeks after discontinuing ETN. Absence of both MRI sacroiliitis and high hs-CRP at baseline predicted response maintenance after ETN withdrawal. (ClinicalTrials.gov: NCT02509026)
In this issue
The Journal of Rheumatology
Vol. 50, Issue 3
1 Mar 2023
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial
Filip Van den Bosch, James Cheng-Chung Wei, Peter Nash, Francisco J. Blanco, Daniela Graham, Chuanbo Zang, Edmund Arthur, Cecilia Borlenghi, Vassilis Tsekouras, Bonnie Vlahos, Atul Deodhar
The Journal of Rheumatology Nov 2022, jrheum.220353; DOI: 10.3899/jrheum.220353
Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial
Filip Van den Bosch, James Cheng-Chung Wei, Peter Nash, Francisco J. Blanco, Daniela Graham, Chuanbo Zang, Edmund Arthur, Cecilia Borlenghi, Vassilis Tsekouras, Bonnie Vlahos, Atul Deodhar
The Journal of Rheumatology Nov 2022, jrheum.220353; DOI: 10.3899/jrheum.220353
