• Jonathan Kay, Eric L Matteson, Bhaskar Dasgupta, Peter Nash, Patrick Durez, Stephen Hall, Elizabeth C Hsia, John Han, Carrie Wagner, Zhenhua Xu, Sudha Visvanathan, and Mahboob U Rahman.
• Rheumatology Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts 02114, USA. jkay@partners.org
• Arthritis Rheum. 2008 Apr 1;58(4):964-75.

ObjectiveTo assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX).MethodsPatients 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.ResultsThe 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.ConclusionGolimumab 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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