Golimumab Receives 2 More FDA Approvals

In late October, the U.S. Food and Drug Administration (FDA) approved golimumab to treat adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). The medication was previously approved to treat moderate to severe active rheumatoid arthritis. Golimumab, a fully human anti-TNF-alpha monoclonal antibody, targets soluble and transmembrane bioactive forms of human TNF-alpha, which cause inflammation when overproduced.¹

These approvals were based on the Phase 3, GO-VIBRANT and GO-ALIVE studies. Both studies were multicenter, randomized, double blind and placebo controlled.

GO-VIBRANT examined golimumab in biologic-naive adults with active PsA (n=480). Patients received 2 mg/kg golimumab at Weeks 0, 4 and then every eight weeks, or placebo at Weeks 0, 4, 12 and 20. Placebo-treated patients crossed over to receive golimumab at Week 24. The primary endpoint was achieving an ACR20 response at Week 14.

GO-ALIVE studied 208 patients with AS who received 2 mg/kg golimumab at Weeks 0, 4 and then every eight weeks or placebo at Weeks 0, 4 and 12. In this study, placebo-treated patients crossed over to receive golimumab at Week 16. The Assessment of Spondyloarthritis International Society criteria (ASAS20) response at Week 16 was the primary endpoint.

In GO-VIBRANT, 75% of golimumab-treated patients vs. 22% of placebo-treated patients attained ACR20 at Week 14. In GO-ALIVE, 73% of golimumab-treated patients vs. 26% placebo-treated patients attained ASAS20 at Week 16. Both responses were considered statistically significant.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

1. Janssen Global Services LLC. Janssen receives two US FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. 2017 Oct 20.