The United States Food and Drug Administration (USFDA) has approved Simponi (Golimumab) injections for the treatment of severe forms of ulcerative colitis in adults.
Simponi, an anti-TNF monoclonal antibody, is previously approved for the treatment of ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis. The approval is mainly for refractory forms of ulcerative colitis that is unresponsive to treatment or that need continuous corticosteroid therapy.
According to Dr. Andrew Mulberg, Deputy Director, Division of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research, Simponi (Golimumab) is an important therapeutic option for moderate to severe forms of ulcerative colitis. Approval of the drug for serious ulcerative colitis now paves an additional option for treatment of painful condition that responds to therapies in a different manner.
The safety and efficacy of Simponi was assessed in two clinical trials among 823 ulcerative colitis patients. The patients were evaluated by stools frequency, rectal bleeding with endoscopic results and clinical examinations.
Around 513 patients with moderate to severe forms of ulcerative colitis were evaluated in the first study. All the patients were either unresponsive to treatment or could not tolerate the adverse events of therapy. The participants randomly received either Simponi or a placebo.
When compared to the placebo group, a greater degree of treatment response was observed in Simponi-treated patients. In the treatment group, notable clinical response, clinical remission was observed in endoscopic studies. Improved colonic morphology was observed after six weeks of Simponi treatment.
In the second clinical trial study, nearly 310 participants were included. Greater degree of clinical response was observed in Simponi-treated patients, and the clinical response was maintained through week 54. However, remissions were reported in weeks 30 and 54. Colonosopic examinations reported improved colonic appearance in both 34th and 54th weeks. No such benefits were observed in the placebo group.
The commonly reported adverse events were injection site reaction including redness and upper respiratory tract infections. Other serious adverse events (SAEs) include remission of Hepatitis B infection, heart failure, allergic reactions, serious sepsis, invasive mycotic infections, nervous system disorders and anaphylactic reactions.