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 the 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 rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis.
About the GO-REVEAL Trial
The GO-REVEAL trial involved 405 adults with psoriatic arthritis. Subjects with at least three swollen and tender joints and active psoriatic skin lesions of at least 2 centimeters in diameter were randomly assigned to receive subcutaneous injections of placebo or golimumab (50 or 100 mg) at week 0 and every 4 weeks thereafter through the end of the study. At week 16, patients with inadequate arthritis response were switched to golimumab 50 mg (patients originally receiving placebo) or golimumab 100 mg (patients originally receiving golimumab 50 mg). At week 24 all placebo patients crossed over to active treatment with golimumab 50 mg. The primary endpoint was ACR 20 response at week 14 for combined golimumab groups and individual golimumab dose groups versus placebo.
Through week 24, the placebo-controlled portion of the study, 2 percent
of golimumab-treated patients experienced serious adverse events (SAE)
compared with 6 percent of patients in the placebo group. Injection site
reactions (ISR) occurred in 5 percent of patients receiving golimumab and 3
percent of patients receiving placebo. One case of prostate cancer and 2
cases of basal cell carcinoma were reported in golimumab-treated patients.
Through week 52, 5 percent of golimumab-treated pat
Copyright©2008 PR Newswire.
All rights reserved