The Biologics License Application (BLA) and Marketing Authorization Application (MAA) for golimumab were submitted earlier in the year and are currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA), respectively. The filings are based on the extensive clinical development program for golimumab, including data from five pivotal Phase 3 trials in RA, psoriatic arthritis and ankylosing spondylitis.
About the GO-AFTER Trial
GO-AFTER was a Phase 3, multi-center, double-blind trial that included 461 patients with active RA of 8.65 years mean duration. All patients had previously received at least one anti-TNF agent, with 25 percent (n=115) having been treated with two therapies and 9 percent (n=43) with three. Discontinuation of previous anti-TNF therapy was due to lack of efficacy (58 percent), intolerance (17 percent) and other reasons (40 percent). Patients were randomized to one of three treatment groups: subcutaneous placebo, golimumab 50 mg or golimumab 100 mg every four weeks. At baseline, 66 percent of patients were receiving methotrexate; 5 percent and 7 percent of patients were receiving sulfasalazine and hydroxychloroquine, respectively. Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline.
Golimumab was generally well tolerated in this study. Through week 24,
72 percent, 66 percent and 78 percent of patients in the placebo, golimumab
50 mg and golimumab 100 mg groups, respectively, experienced at least one
adverse event (AE). Ten percent of patients in the placebo group
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