KAUAI, HAWAII –
And that’s not all: Much the same was true in patients with psoriatic arthritis in the parallel phase 2b BE ACTIVE study and for ankylosing spondylitis in the BE AGILE study. BE ABLE was a double-blind, 12-week, multicenter, five-arm, placebo-controlled, dose-ranging study of 250 psoriasis patients randomized to various doses of subcutaneous bimekizumab or placebo every 4 weeks. The primary outcome – the PASI 90 response rate at 12 weeks, rather than the lower-bar PASI 75 endpoint more typically used in clinical trials – was 79% at the optimal dose. The PASI 100 rate – complete clearance of disease – at 12 weeks was 60%, Craig L. Leonardi, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
lthough Dr. Leonardi is a distinguished psoriasis clinical trialist, he wasn’t involved in the BE ABLE study. Only top line results have been announced to date, although publication of the BE ABLE, BE AGILE, and BE ACTIVE results and presentations at major medical meetings are pending.
Bimekizumab is a humanized IgG1 monoclonal antibody which uniquely neutralizes both IL-17A and IL-17F. In contrast, secukinumab (Cosentyx) and ixekizumab (Taltz) specifically inhibit IL-17A, while brodalumab (Siliq) is a pan-IL-17 receptor antagonist, inhibiting the IL-17 A, A/F, E, F, and C receptors. The impressive clinical outcomes of the three BE phase 2b studies validate the notion that IL-17F is an important cytokine in tissue inflammation across a range of dermatologic and rheumatologic diseases.
A long-term extension of BE ABLE is ongoing. In addition, a phase 3 randomized trial of bimekizumab versus adalimumab (Humira) versus placebo in 450 psoriasis patients is now recruiting, as is a separate phase 3 placebo-controlled head to head comparison of bimekizumab versus ustekinumab (Stelara).
The BE ACTIVE study included 206 psoriatic arthritis patients. At the top dose of bimekizumab, the week 12 rate of at least a 50% improvement in joint symptoms, or ACR 50 response, was 46%, compared with 7% in placebo-treated controls. Patients with concomitant psoriasis over at least 3% of their body surface area demonstrated a 65% PASI 90 response rate at 12 weeks.
BE AGILE included 303 patients with ankylosing spondylitis. Forty-seven percent of those randomized to the top-performing dose of bimekizumab had at least a 40% improvement in their Ankylosing Spondylitis Activity Score, or ASAS 40, at week 12, as did 13% in the placebo arm.
Bimekizumab is being developed by UCB, which is planning additional studies advancing the biologic in all three diseases studied in the phase 2b trials.
Dr. Leonardi reported receiving research grants from well over a dozen pharmaceutical companies and serving as a consultant to UCB and others.
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