The study met the primary objective of establishing dose response for bimekizumab and demonstrated significant efficacy compared with placebo. At Week 12, 79% of bimekizumab-treated patients achieved at least 90% skin clearance in the Psoriasis Area and Severity Index (PASI90). A secondary efficacy objective was complete skin clearance at Week 12 as measured by PASI100. Up to 60% of bimekizumab-treated patients achieved this endpoint.
The safety profile of bimekizumab showed no new safety signals. The most common adverse events observed were nasopharyngitis and upper-respiratory tract infection. Phase 3 studies are currently planned.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Boehringer Ingelheim Pharmaceuticals Inc. News release: Boehringer Ingelheim Pharmaceuticals Inc. receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases. 2017 Aug 29.
- Eli Lilly and Co. News release: Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018. 2017 Aug 30.
- Eli Lilly and Co. News release: U.S. FDA issues complete response letter for baricitinib. 2017 Apr 14.
- Pfizer Inc. News release: FDA advisory committee votes in favor of Xeljanz (tofacitinib citrate) for the treatment of active psoriatic arthritis. 2017 Aug 3.
- Walsh N. FDA panel says yes to tofacitinib for PsA—clear efficacy for symptoms, but radiographic progression benefit remains unclear. Medpage Today. 2017 Aug 3.
- UCB. News release: Bimekizumab demonstrates skin clearance in phase 2b psoriasis study with first monoclonal antibody neutralizing both IL-17A and IL-17F. 2017 Jul 21.
