Long-term golimumab persistence: Five-year treatment retention data pooled from pivotal Phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

INTRODUCTION

Golimumab, a monoclonal antibody against tumor necrosis factor-α (TNF-α), is used widely for treatment of rheumatic diseases. Long-term persistence is an important factor influencing therapeutic benefit and is a surrogate measure of efficacy. We compared five-year golimumab treatment persistence across studies, indications, and lines of therapy using pooled data from pivotal golimumab Phase III clinical trials.

METHODS

This post-hoc analysis evaluated use of golimumab administered subcutaneously (50 or 100 mg every four weeks) for up to five years in 2228 adult participants with rheumatoid arthritis (RA; GO-BEFORE, GO-AFTER, and GO-FORWARD studies), psoriatic arthritis (PsA; GO-REVEAL study), or ankylosing spondylitis (AS; GO-RAISE study). Retention rate differences were evaluated by study, indication, and line of therapy using log-rank tests, and probability of treatment persistence was estimated by Kaplan-Meier analysis.

RESULTS

Golimumab retention rates at Year 5 were consistently high when used as 1-line therapy (69.8%) and did not differ significantly across the three indications tested (p = 0.5106) or across 1-line studies (p = 0.2327). Retention at Year 5 was better in participants using golimumab as 1-line than in those using it as 2-line (41.6%) therapy. Participants on 2-line golimumab therapy had a longer disease duration (median 9.2 years versus 3.7 years) than those on 1-line golimumab therapy.

CONCLUSIONS

These data support the value of long-term golimumab therapy in patients with chronic, immune-mediated rheumatic diseases when used as 1-line (RA, PsA, AS) or 2-line (RA) therapy. Key Points • Golimumab is a human monoclonal antibody directed against tumor necrosis factor-α (TNF-α) and is approved widely for the treatment of rheumatic autoimmune diseases. • We compared the probability of treatment persistence, or the time of continuous drug use, for golimumab across five Phase III studies spanning multiple rheumatic indications over five years. • Treatment persistence was favorable and did not differ significantly for participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, but persistence was greater when golimumab was used as 1st-line than as 2nd-line biologic therapy.