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Rheumatology Practice Management September 2013 Vol 1 No 1 — September 11, 2013

The US Food and Drug Admini­stration (FDA) approved a new indication for golimumab (Simponi Aria for infusion; Janssen Biotech) for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA) to be used in combination with methotrexate. Only 2 months earlier, the FDA approved golimumab injection for the treatment of patients with ulcerative colitis.

This is the first FDA approval of a fully human anti–tumor necrosis factor (TNF) therapy for infusion. The approval was based on findings from the phase 3 clinical trial known as GO-FURTHER (Golimumab, an Anti- TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy). The study included 592 patients with moderate-to-severe active RA who had at least 6 tender and 6 swollen joints, as well as elevated C-reactive protein levels, and who had been receiving background methotrexate for ≥3 months.

At week 14, 30% of the patients receiving golimumab plus methotrexate achieved at least a 50% improvement in American College of Rheumatology (ACR) response criteria (ACR50) compared with 9% of the patients receiving placebo plus methotrexate (95% confidence interval, 15.3-27.2). Significant improvements in ACR20 were seen as early as week 2: 33% of patients achieved an ACR20 response after 1 infusion of golimumab versus 12% of patients receiving placebo.
Golimumab is administered as an intravenous dose of 2 mg/kg at weeks 0 and 4 and then every 8 weeks. The drug is infused over a 30-minute period.

In the GO-FURTHER trial, golimumab significantly improved the signs and symptoms of RA by week 24 “and inhibited the progression of structural damage in patients with moderate to severe RA at week 24 and 52,” said Sergio Schwartzman, MD, Director, Inflammatory Arthritis Center, Hospital for Special Surgery, and Associate Professor, Weill Cornell Medical College, New York, NY. This approval “offers rheumatologists a new anti-TNF infusible treatment for patients who demonstrate an inadequate response to methotrexate; having treatment options remains critical for us to continue to meet the needs of our patients,” Dr Schwartzman added. (July 18, 2013)

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