Vito Annese
Valiant Clinic Dubai, UAE
Title: Biosimilars in inflammatory bowel disease: A review of post-marketing experience
Biography
Biography: Vito Annese
Abstract
The introduction of anti-tumor necrosis factor alpha (anti-TNFa) antibodies about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients. Inflximab has been the first anti-TNFα agent to be used and the first to lose the patent, whereas CT-P13 (Celltrion) has been the first infliximab biosimilar to be available. The clinical trial program of CT-P13 have been performed in patients with ankylosing spondylitis (AS) and rheumatoid arthritis (RA). Both were randomized, double-blind, multinational trials with 30 weeks of treatment, subsequently followed-up to 54 weeks with a further open-label 48-week extension and switch from infliximab to CT-P13. All these studies have demonstrated pharmacokinetic equivalence and clinical efficacy in both AS and RA up to 102 weeks, also after switching. The indication of CT-P13 has been extended since 2013 by EMA and more recently by FDA and Health Canada also to IBD.
So far no controlled trials are available in IBD, therefore we have made an extensive review of the available open label case series of IBD patients treated across the world. More than 600 IBD patients were evaluated, 39 in paediatric age, and 183 switched from inflximab. In most cases, only a clinical evaluation was performed. The mean efficacy was 72%, the rate of adverse events 10.4%, and the rate of infusion reactions was 5.5%. These findings are very much comparable to the experience with infliximab, waiting for the data of the controlled trials.
