Infliximab biosimilar safe and effective for inflammatory bowel disease

Last Updated: 2017-03-13

By Will Boggs MD

NEW YORK (Reuters Health) - The infliximab biosimilar CT-P13 (Remsima) is safe and effective against inflammatory bowel disease (IBD), according to a systematic review and meta-analysis.

"Physicians should not be hesitant to use or switch to biosimilars,” Dr. Atsushi Sakuraba from the University of Chicago told Reuters Health by email. “Just like in EU and Asian countries, the trend of widespread use of biosimilars is inevitable.”

Dr. Sakuraba’s team assessed the clinical efficacy and safety of CT-P13 in their systematic review and meta-analysis of 11 observational studies reporting outcomes in 829 patients.

Pooled rates of clinical response to CT-P13 were high: 79% at 8 to 14 weeks and 77% at 24 to 30 weeks among Crohn's disease patients, and 74% at 8 to 14 weeks and 77% at 24 to 30 weeks among ulcerative colitis patients, according to the February 26th Alimentary Pharmacology and Therapeutics online report.

Clinical remission rates for Crohn's disease patients were 66% at 8 to 14 weeks and 60% at 24 to 30 weeks, and clinical remission rates for ulcerative colitis patients were 50% at 8 to 14 weeks and 52% at 24 to 30 weeks.

Overall adverse event rates were 8% for both groups of patients.

Results were equally favorable or better in studies where patients were switched from infliximab to CT-P13 and appeared to be comparable to outcomes seen with infliximab.

“Our current study did not include any randomized controlled trials as there have been none performed in IBD,” Dr. Sakuraba explained, “but our meta-analysis in rheumatoid disease, which was recently published in another journal and included RCTs, demonstrated similar findings.”

Dr. Fernando Gomollon, chief of the IBD unit at Hospital Clinico Universitario “Lozano Blesa,” Facultad de Medicina, Zaragoza, Spain, told Reuters Health by email, “Biosimilarity as defined by EMA, Health Canada, FDA, or other reliable regulatory agencies is a well developed concept. If EMA or FDA approves a biosimilar, you can be confident in clinic and use it in your patients.”

“We do use biosimilars, and this summary of evidence gives us no real new data,” he said. “Market forces and payers’ decisions will be key in the biosimilar arena. One hopes access for complex and expensive drugs will be easier for patients, but maybe different barriers could make this a bit difficult.”

SOURCE: http://bit.ly/2ne60cJ

Aliment Pharmacol Ther 2017.