Pooled Safety Results Across Phase 3 Randomized Trials of Intravenous Golimumab in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

AS ankylosing spondylitis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BMI body mass index, CRP C-reactive protein, IV intravenous, NSAID non-steroidal anti-inflammatory drug, PsA psoriatic arthritis, RA rheumatoid arthritis, SD standard deviation
*Data presented as mean (SD) unless otherwise noted
**Among patients with investigator-assessed spondylitis in addition to peripheral arthritis as their primary presentation of PsA
***Prednisone or equivalent

AE adverse event, AS ankylosing spondylitis, ALT alanine aminotransferase, AST aspartate aminotransferase, IV intravenous, PsA psoriatic arthritis, RA rheumatoid arthritis, SAE serious adverse event
*Data presented as n (%) unless otherwise noted
**AEs occurring in ≥ 3% of patients in any treatment group

AE adverse event, AS ankylosing spondylitis, CI confidence interval, IV intravenous, MACE major adverse cardiovascular event, PsA psoriatic arthritis, RA rheumatoid arthritis, SAE serious adverse event, SD standard deviation, TB tuberculosis
*Data presented as n (%) unless otherwise noted

"+" indicates with methotrexate; "−" indicates without methotrexate
AE adverse event, ALT alanine aminotransferase, AS ankylosing spondylitis, CI confidence interval, PBO placebo, PsA psoriatic arthritis, PY patient-years, RA rheumatoid arthritis, SAE serious adverse event, ULN upper limit of normal
*Data presented as n (%), n/N (%), or events/100 PY (95% CI), unless otherwise noted
**The three trials ranged from 60 to 112 weeks in duration (Figure 1). Time-adjusted incidence of AEs (events/100 PY) are shown
***Antibodies to golimumab were assessed using a drug-tolerant enzyme immunoassay at 52 weeks for all three trials

"+" indicates with corticosteroids; "−" indicates without corticosteroids
AE adverse event, AS ankylosing spondylitis, CI confidence interval, PBO placebo, PsA psoriatic arthritis, PY patient-years, RA rheumatoid arthritis, SAE serious adverse event
*Data presented as n (%) or events/100 PY (95% CI), unless otherwise noted
**The three trials ranged from 60 to 112 weeks in duration (Figure 1). Time-adjusted incidence of AEs (events/100 PY) is shown

Authors and Disclosures

M. Elaine Husni¹*, Atul Deodhar², Sergio Schwartzman³, Soumya D. Chakravarty^4,5, Elizabeth C. Hsia^6,7, Jocelyn H. Leu⁶, Yiying Zhou⁶, Kim H. Lo⁶ and Arthur Kavanaugh<sup>8

1</sup>Department of Rheumatic and Immunologic Diseases, Clinical Outcomes Research, Arthritis and Musculoskeletal Center, Cleveland Clinic, Desk A50, 9500 Euclid Ave., Cleveland, OH 44195, USA. ²Oregon Health & Science University, Portland, OR, USA. ³Weill Cornell Medical College, New York, NY, USA. ⁴Janssen Scientific Affairs, LLC, Horsham, PA, USA. ⁵Drexel University College of Medicine, Philadelphia, PA, USA. ⁶Janssen Research & Development, LLC, Spring House, PA, USA. ⁷University of Pennsylvania, Philadelphia, PA, USA. ⁸University of California San Diego, La Jolla, CA, USA.

*Correspondence
husnie@ccf.org

Authors' contributions
Study design: MEH, AD, ECH, KHL, and AK. Data collection: JHL and YZ. Data interpretation: MEH, AD, SS, SDC, ECH, JHL, YZ, KHL, and AK. All authors revised the manuscript and gave final approval for submission.

Competing interests
MEH has received honoraria for participation in advisory boards (AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Regeneron, UCB).
AD has participated in advisory boards (AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB), received research grants (AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB), and participated in speakers' bureaus (AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB).
SS has received consulting fees, research grants, speakers' bureau activity, or ownership or partnership (AbbVie, Amgen, Boston Scientific, Crescendo Bioscience, Dermtech, Eli Lilly, Genentech, Gilead Sciences, Janssen, Medtronic, Myriad Genetics, National Psoriasis Foundation, Novartis, Pfizer, Regeneron, Samsung, Sanofi, UCB) and participated in advisory boards (Jubilant, Myriad, Stelexis).
AK has received research support and/or consulting fees (AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, UCB) SDC is an employee of Janssen Scientific Affairs, LLC, and owns stock in Johnson & Johnson.
ECH, JHL, YZ, and KHL are or were employees of Janssen Research & Development, LLC, at the time this work was performed and own stock in Johnson & Johnson.