Five-year-data from a randomized trial confirm the efficacy and safety of golimumab in psoriatic arthritis.
Kavanaugh A, McInnes IB, Mease P, et al. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial, the GO-REVEAL study). Ann Rheum Dis. 2014 [Epub ahead of print: April 19] doi:10.1136/annrheumdis-2013-204902
A majority of psoriatic arthritis (PsA) patients achieve significant improvements in joint pain and swelling as well as skin lesions over five years with golimumab (Simponi), according to final results of a major randomized clinical trial.
Results from the phase III GO-REVEAL trial – the longest available trial data for any tumor necrosis factor (TNF) drug in PsA – also show subcutaneous golimumab inhibits radiographic progression of the disease and that its long-term use is safe.
Response rates of 20% or greater improvement in American College of Rheumatology (ACR20) criteria with golimumab were 62.8%-69.9%, regardless of whether patients also took methotrexate (MTX).
For ACR50, response rates were 43.4%-50.7%, and 30.8%-35.6% for ACR70, with or without concomitant MTX.
Disease activity for 28 joints with C-reactive protein (DAS28-CRP) scores improved from 4.9-5.0 at baseline to below 3.2 across all treatment groups.
Over 60% of patients achieved an improvement of 75% or above in the Psoriasis Area and Severity Index (PASI75). Over half of patients showed clinically meaningful improvements in physical function, enthesitis, and dactylitis.
Comparison with available baseline X-rays revealed slowed disease progression (mean changes of 0.1-0.3 in PsA-modified Sharp/van der Heijde scores), with more improvement among patients taking MTX.
GO-REVEAL was begun in 2005, initially randomizing 405 patients with active PsA (three or more swollen and tender joints plus active psoriasis) to subQ placebo or 50mg or 100 mg of subQ golimumab every month for the first 20 weeks.
After 24 weeks, all patients received active drug. A total of 126 patients (31%) withdrew from the trial. One-quarter of the remaining patients had a dose escalation to 100 mg during the long-term extension (LTE). Around half of patients took MTX.
Adverse events were similar in all treatment groups, mostly infections.
Trial data were limited by lack of controls after six months, open-label design of the LTE and dose escalations, the researchers point out.