Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study
Department of Medicine, Division of Rheumatology
Aged; Antibodies, Monoclonal; Antirheumatic Agents; Arthritis, Rheumatoid; Dose-Response Relationship, Drug; Double-Blind Method; Drug Resistance; Female; Humans; Immunologic Factors; Male; Methotrexate; Middle Aged; Severity of Illness Index
Musculoskeletal Diseases | Rheumatology | Skin and Connective Tissue Diseases
OBJECTIVE: To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX).
METHODS: Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo.
RESULTS: The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P=0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P < 0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group.
CONCLUSION: Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.
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Citation: Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383. Link to article on publisher's site
Arthritis and rheumatism
Kay, Jonathan; Matteson, Eric L.; Dasgupta, Bhaskar; Nash, Peter; Durez, Patrick; Hall, Stephen; Hsia, Elizabeth C.; Han, John; Wagner, Carrie; Xu, Zhenhua; Visvanathan, Sudha; and Rahman, Mahboob U., "Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study" (2008). Rheumatology Publications and Presentations. 86.