BE SURE study: Bimekizumab achieves PASI 90 at 16 weeks in psoriasis

The investigational IL-17A and IL-17F inhibitor bimekizumab was superior to adalimumab in achieving a 90% improvement in Psoriasis Area and Severity Index score after 16 weeks, according to a press release from UCB.

The randomized, double-blind BE SURE study is the third phase 3 trial of bimekizumab for the treatment of moderate to severe plaque psoriasis.

“Collectively, the results seen in the BE SURE, BE READY and BE VIVID studies support the potential of bimekizumab to be a meaningful new treatment option,” Kristian Reich, MD, PhD, professor of Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany, and BE SURE lead study investigator, told Healio. “Bimekizumab selectively and effectively neutralizes both IL-17A and IL-17F, two key cytokines that drive keratinocyte activation in psoriasis. Preclinical results in disease-relevant cells have shown that neutralizing both these cytokines reduces skin inflammation.”

BE SURE enrolled 478 patients with chronic plaque psoriasis for at least 6 months before screening and 10% or greater affected body surface area. Patients also had a Psoriasis Area and Severity Index (PASI) score of 12 or higher and an Investigator Global Assessment (IGA) score of 3 or higher.

Coprimary endpoints included PASI 90 response and IGA response of clear or almost clear and at least a two-category improvement from baseline.

The study met all the secondary endpoints: Bimekizumab achieved statistically significant superior total skin clearance at weeks 16 and 24 (PASI 100) compared with Humira (adalimumab, AbbVie), as well as rapid response (PASI 75) at week 4.

Additionally, bimekizumab was associated with maintained levels of skin clearance during the dose-blind maintenance period through week 56.

Complete results of the trial will be presented at a scientific congress in 2020, according to the release.

“Based on the strength of the results from the phase 3 program to date, UCB plans to submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate to severe plaque psoriasis in mid-2020,” Reich told Healio. “The safety and efficacy of bimekizumab are also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, with first top-line results expected by the end of 2021.”

Disclosure: Reich reports he has served as an advisor and paid speaker and has participated in clinical trials for AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Celgene, Covagen, Forward Pharma, Fresenius Medical Care, GlaxoSmithKline, Janssen, Janssen-Cilag, Kyowa Kirin, Leo Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotec, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, XBiotech and XenoPort.