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Arthritis Drug Simponi (Golimumab) Gets Expanded Indication for Ulcerative Colitis
The FDA has approved a new use for Simponi (golimumab; Janssen Ortho Biotech) injection to treat adults with moderate-to-severe ulcerative colitis.
Golimumab works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses. Previously approved to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, the drug is now indicated for adults with moderate-to-severe ulcerative colitis that is refractory to prior treatment or requires continuous steroid therapy.
Ulcerative colitis is a chronic disease that affects approximately 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease. The inflammation can lead to abdominal discomfort, gastrointestinal bleeding, the production of pus, and diarrhea.
The safety and effectiveness of Simponi (golimumab) for ulcerative colitis were established in two clinical studies. Patient evaluations included measures of stool frequency, rectal bleeding, endoscopic findings, and the physician’s overall assessment.
In the first study, 513 patients with moderate-to-severe ulcerative colitis who could not tolerate or failed to respond to other therapies were randomly assigned to receive golimumab or a placebo. A greater proportion of golimumab-treated patients achieved a clinical response, clinical remission, and an improved appearance of the colon (as seen during endoscopy) after 6 weeks of treatment compared with the placebo group.
In the second study, 310 patients with moderate-to-severe ulcerative colitis who were responders to golimumab were randomly assigned to receive golimumab or placebo. A greater proportion of golimumab-treated patients maintained a clinical response through week 54; had achieved clinical remission at weeks 30 and 54; and, as seen during endoscopy, had an improved appearance of the colon at weeks 30 and 54 compared with the placebo group.
The most common side effects in patients treated with golimumab include upper respiratory-tract infection and redness at the site of injection. Patients treated with golimumab are at increased risk of developing serious infections, invasive fungal infections, reactivation of hepatitis B infection, lymphoma, heart failure, nervous system disorders, and allergic reactions.
Source: FDA; May 15, 2013.