The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting..
ORLANDO – Biosimilar BI 695501 demonstrated non-inferior efficacy and similar safety profile compared with the reference product adalimumab in patients with active Crohn disease, according to research presented at the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Annual Meeting, held December 12-14, 2019 in Orlando, FL.
Investigators conducted a randomized, double-blind, multicenter, non-inferiority, phase 3 trial (Study 1297.4) evaluating the efficacy and safety of BI 695501 compared with adalimumab reference product (RP) in patients with moderate to severe active Crohn disease for at least 4 months with evidence of mucosal ulceration. The primary endpoint was the proportion of patients with clinical response, defined as Crohn Disease Activity Index (CDAI) decrease of ≥70 from baseline, at Week 4. Safety profiles up to Week 24 were also analyzed and compared between the two patient groups.
Study findings showed that biosimilar BI 695501 is non-inferior to adalimumab RP in efficacy after 4 weeks of treatment. Patients in both groups demonstrated similar response rates, with 89.7% of patients with CDAI response in the BI 695501 group, compared with 94.4% of patients in the adalimumab RP group (RR 0.945; 90% CI: 0.870, 1.028). The investigators found similar safety profiles up to Week 24 between the two groups, with no unexpected safety findings. Infection rates were similar for BI 695501 and adalimumab RP (23.6% vs 22.7% respectively), and no patient experienced injection site reactions with BI 695501 (6.7% with adalimumab RP).
In this actively controlled study, the authors concluded that BI 695501 is comparable to its reference product for Crohn disease, with high clinical response and remission rates at Week 4 between the two groups.
Hanauer S, Schreiber S, Balser S, Liedert B. Biosimilar BI 695501 Demonstrates Non-inferior Efficacy and Comparable Safety to Adalimumab Reference Product in Patients with Active Crohn’s Disease. Presented at the 2019 AIBD Annual Meeting on December 12-14 in Orlando, FL.