Golimumab, a Human Anti–Tumor Necrosis Factor Monoclonal Antibody, Injected Subcutaneously Every 4 Weeks in Patients With Active Rheumatoid Arthritis Who Had Never Taken Methotrexate: 1‐Year and 2‐Year Clinical, Radiologic, and Physical Function Findings of a Phase III, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Study

Abstract

Objective. To assess 2-year golimumab efficacy/safety in patients with active rheumatoid arthritis (RA) who had never taken methotrexate (MTX).Methods. RA patients who had never taken MTX (n ‫؍‬ 637) were randomized (1:1:1:1) to placebo ؉ MTX (group 1), golimumab 100 mg ؉ placebo (group 2), golimumab 50 mg ؉ MTX (group 3), or golimumab 100 mg ؉ MTX (group 4) every 4 weeks. Nonresponders based on week 28 swollen/tender joint counts changed treatment as follows: group 1 added golimumab 50 mg, group 2 added MTX, group 3 increased golimumab to 100 mg, and group 4 had no change. Most group 1 patients (85%) initiated golimumab 50 mg ؉ MTX at week 28 or subsequently at week 52. After the last patient completed week 52 and blinding was broken, the investigator could escalate golimumab to 100 mg and/or adjust MTX.

Efficacy and safety results from a Phase 3, randomized, placebo‐controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy

“…Through week 56, half of all patients who received ≥ 1 golimumab injection reported ≥ 1 AE. The safety events observed in this trial were consistent with those observed in previous trials of golimumab in patients with RA, with infections being the most common type of AE. During the placebo‐controlled phase of the trial, rates of AEs were similar between patients who received either placebo or golimumab in addition to MTX.…”

Clinical efficacy, radiographic, and safety results of golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior therapy with disease-modifying antirheumatic drugs: Final results of the GO-MONO trial through week 120

“…The incidence and type of AEs observed in GO-MONO were consistent with previous phase 3 trials of SC golimumab in patients with rheumatic diseases [21][22][23][24][25], including the GO-FORTH trial of Japanese patients with RA who received golimumab plus MTX [26]. No apparent dose effect was observed.…”

Maintenance of Clinical and Radiographic Benefit With Intravenous Golimumab Therapy in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy: Week‐112 Efficacy and Safety Results of the Open‐Label Long‐Term Extension of a Phase III, Double‐Blind, Randomized, Placebo‐Controlled Trial

“…The safety results of this trial were consistent with the safety profile of other trials of anti‐TNF therapies administered either as IV infusion or subcutaneous injection , and no unexpected safety events occurred through week 112. As seen with other anti‐TNF agents, infections were the most common type of AE reported.…”