Bimekizumab Safe and Effective in Moderate-to-Severe Plaque Psoriasis
By Marielle Fares, PharmD
Washington, DC -- March 8, 2019 -- Bimekizumab, a selective and potent inhibitor of interleukin (IL)-17A and IL-17F, shows rapid, effective, and safe results with long-term, subcutaneous dosing every 4 weeks, according to a study presented here at the 2019 Annual Meeting of the American Academy of Dermatology (AAD).
Andrew Blauvelt, MD, MBA, Oregon Medical Research Center, Portland, Oregon, presented the results on March 2.
Dr. Blauvelt and colleagues recruited 217 Psoriasis Area and Severity Index [PASI] 90 responders (percentage of patients who have achieved a ≥90% reduction in their PASI score from baseline) from the 12-week phase 2a BE ABLE 1 study into their extension trial.
The researchers administered placebo or bimekizumab 64, 160, or 160 mg with a 320-mg loading dose every 4 weeks for 48 weeks. They switched nonresponders (PASI
BE ABLE 1 responders maintained complete or near-complete skin clearance for 48 weeks, with a PASI90 of 80% to 100%. Furthermore, 70% to 83% of responders achieved PASI100, and 78% to 100% achieved the Investigator’s Global Assessment 0/1.
The safety profile of bimekizumab was similar to that observed in previous studies. The most frequent treatment-emergent adverse events (TEAEs) included nasopharyngitis and oral candidiasis. The exposure-adjusted incidence rate for serious TEAEs (defined as the number of patients with an adverse event divided by the total exposure time among total patients) was 6.2/100 patient-years (15 [7%] of 217 patients).
These results represent the longest-term data showing durable response with bimekizumab at 60 weeks, as measured by PASI90 and PASI100.
Dr. Blauvelt highlighted the unique mechanism of action of bimekizumab and the role of dual inhibition of IL-17A and IL-17F in maintaining long-term response and skin clearance in psoriasis and targeting multiple inflammatory processes.
Funding for this study was provided by UCB (Union Chimique Belge), Brussels, Belgium.
Presentation title: Dual Neutralization of Interleukin (IL) 17A and IL 17F With bimekizumab in Moderate-to-Severe Plaque Psoriasis: 60-Week Results From a Randomized, Double-Blinded, Phase 2b Extension Study. Abstract 11180