The approval of the biologic drug golimumab has been expanded to include the treatment of adults with moderate to severe ulcerative colitis that is refractory to prior treatment or requires continuous steroid therapy, the Food and Drug Administration announced on May 15.
Golimumab (Simponi), a tumor necrosis factor–blocker, was approved in 2009 for treatment of moderate to severe active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, all in adults. Simponi is marketed by Janssen Ortho Biotech.
The approval for ulcerative colitis was based on two studies of patients with moderate to severe ulcerative colitis, according to the FDA statement announcing the approval. In one study, which enrolled 513 patients who could not tolerate or had not responded to other treatments, "a greater proportion of Simponi-treated patients achieved clinical response, clinical remission and, as seen during endoscopy, had improved appearance of the colon after 6 weeks," compared with those on placebo, the statement said.
In a study of 310 patients who had responded to golimumab and were then randomized to continue treatment with golimumab or were switched to placebo, "a greater proportion of Simponi-treated patients maintained clinical response through week 54, had clinical remission at both weeks 30 and 54 and, as seen during endoscopy, had improved appearance of the colon at both weeks 30 and 54 compared with the placebo group," the FDA said. The most common adverse effects associated with golimumab are upper respiratory infection and redness at the injection site.
The risks of serious infections, invasive fungal infections, reactivation of hepatitis B infection, lymphoma, heart failure, nervous system disorders, and allergic reactions are increased with treatment.
Serious adverse events associated with golimumab should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch/.
