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

M. Elaine Husni; Atul Deodhar; Sergio Schwartzman; Soumya D. Chakravarty; Elizabeth C. Hsia; Jocelyn H. Leu; Yiying Zhou; Kim H. Lo; Arthur Kavanaugh


Arthritis Res Ther. 2022;24(73) 

In This Article


These pooled analyses from three double-blind, randomized, placebo-controlled, phase 3 trials of patients with RA, PsA, and AS included safety data from 1280 patients for a total of 1697 PY of follow-up. Infusion reactions were uncommon across the three studies. Concomitant use of MTX and of low-dose oral corticosteroids was associated with a higher occurrence of ALT elevations and serious infections, respectively. Overall, most elevations in liver transaminases were mild and transient, and few patients experienced a serious infection. The safety profile of IV golimumab was generally consistent across the RA, PsA, and AS trials, as well as with other TNFi.