Use of FK-adalimumab biosimilar (MSB 11022) in context of biologic switch in Inflammatory Bowel Diseases : 6 months data of the real-world IDEA study

Abstract

Background: Biosimilars offer similar efficacy and safety when compared to their originators, thereby enhancing patient access to more affordable treatments. FK-adalimumab (FK-ada) is an adalimumab biosimilar approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). FK-ada development included 1,234 subjects treated up to 52 weeks (total 420 patients-year). Since first approval, there have been no unexpected safety signals despite more than 115,000 patient-years of exposure. IDEA is an ongoing real-world study aimed to assess persistence with FK-ada and develop a predictive model of persistence at 12 months. In this study, adult patients with IBD who switched from adalimumab originator or another adalimumab biosimilar to FK-ada are followed up to one year.