Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial
Annals of Rheumatic Diseases, 06/07/2012
Weinblatt ME et al. – The addition of intravenous golimumab rapidly and significantly improved signs and symptoms in patients with active rheumatoid arthritis (RA) despite ongoing methotrexate (MTX), in some patients by week 2.Methods
- Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C–reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15–25 mg/week) participated in this double–blind, placebo–controlled, phase 3 study.
- Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX.
- Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg.
- The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response.
- Analyses employed non–responder imputation and last–observation–carried–forward.
- At week 14, significantly (p<0.001) larger proportions of golimumab+MTX than placebo+MTX patients achieved ACR20 response (59% vs 25%, respectively), a disease activity score of good/moderate (EULAR) response (81% vs 40%), and greater median improvement in health assessment questionnaire scores (0.500 vs 0.125).
- Improvements versus placebo+MTX were observed by week 2. Similar proportions of patients receiving golimumab+MTX and placebo+MTX, respectively, reported adverse events through week 16 (47% and 44%) and week 24 (53% and 49%).
- Serious adverse events were reported by more golimumab+MTX (4.1%) than placebo+MTX (2%) patients at week 24.