Research ArticleArticle
Efficacy and Safety of Ustekinumab in Patients With Active Systemic Lupus Erythematosus: Results of a Phase II Open-label Extension Study
Ronald F. van Vollenhoven, Bevra H. Hahn, George C. Tsokos, Peter Lipsky, Robert M. Gordon, Kaiyin Fei, Kim Hung Lo, Marc Chevrier, Shawn Rose, Pamela Berry, Zhenling Yao, Chetan S. Karyekar and Qing Zuraw
The Journal of Rheumatology December 2021, jrheum.210805; DOI: https://doi.org/10.3899/jrheum.210805
Ronald F. van Vollenhoven
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Bevra H. Hahn
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
George C. Tsokos
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Peter Lipsky
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Robert M. Gordon
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Kaiyin Fei
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Kim Hung Lo
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Marc Chevrier
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Shawn Rose
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Pamela Berry
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Zhenling Yao
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Chetan S. Karyekar
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
Qing Zuraw
This study was funded by Janssen Research & Development, LLC. R.F. van Vollenhoven, MD, Amsterdam University Medical Centers, Amsterdam, the Netherlands; B.H. Hahn, MD, University of California Los Angeles, California, USA; G.C. Tsokos, MD, Beth Israel Deaconess Medical Center, Department of Medicine, Boston, Massachusetts, USA; P. Lipsky, MD, AMPEL BioSolutions, LLC, Charlottesville, Virginia, USA; R.M. Gordon, MS, K. Fei, MD, K.H. Lo, PhD, M. Chevrier, MD, PhD, S. Rose, MD, PhD, Z. Yao, PhD, C.S. Karyekar, MD, PhD, Q. Zuraw, MD, Janssen Research & Development, LLC, Spring House, Pennsylvania, USA; P. Berry, MSc, Immunology Strategic Market Access, Janssen Pharmaceutical Companies of Johnson & Johnson, Horsham, Pennsylvania, USA. M. Chevrier passed away on February 6, 2021. RFvV has received consulting fees, speaking fees, and/or honoraria from AbbVie, AstraZeneca, Biotest, BMS, Celgene, Eli Lilly, GSK, Janssen, Medac, Merck, Novartis, Pfizer, Roche, and UCB, and research support from AbbVie, Arthrogen, BMS, Eli Lilly, GSK, Pfizer, and UCB. BHH has received consulting fees, speaking fees, and/or honoraria from Aurinia, GSK, and UCB. GCT has received consulting fees from A2 Therapeutics and research support from Janssen. PL has received consulting fees from Janssen. RMG, KF, KHL, MC, SR, ZY, CSK, and QZ are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC, is a wholly owned subsidiary. PB is an employee of Janssen Pharmaceutical Companies of Johnson & Johnson and owns stock in Johnson & Johnson. Address correspondence to Dr. R.F. van Vollenhoven, Amsterdam University Medical Centers, University of Amsterdam, PO Box 7057, 1007 MB Amsterdam, the Netherlands. Email: r.vanvollenhoven@amsterdamumc.nl. Accepted for publication November 19, 2021.
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The Journal of Rheumatology
Vol. 51, Issue 4
1 Apr 2024
Efficacy and Safety of Ustekinumab in Patients With Active Systemic Lupus Erythematosus: Results of a Phase II Open-label Extension Study
Ronald F. van Vollenhoven, Bevra H. Hahn, George C. Tsokos, Peter Lipsky, Robert M. Gordon, Kaiyin Fei, Kim Hung Lo, Marc Chevrier, Shawn Rose, Pamela Berry, Zhenling Yao, Chetan S. Karyekar, Qing Zuraw
The Journal of Rheumatology Dec 2021, jrheum.210805; DOI: 10.3899/jrheum.210805
Efficacy and Safety of Ustekinumab in Patients With Active Systemic Lupus Erythematosus: Results of a Phase II Open-label Extension Study
Ronald F. van Vollenhoven, Bevra H. Hahn, George C. Tsokos, Peter Lipsky, Robert M. Gordon, Kaiyin Fei, Kim Hung Lo, Marc Chevrier, Shawn Rose, Pamela Berry, Zhenling Yao, Chetan S. Karyekar, Qing Zuraw
The Journal of Rheumatology Dec 2021, jrheum.210805; DOI: 10.3899/jrheum.210805