UCB’s Bimekizumab Outplays the Competition in Two Phase 3 Psoriasis Trials

Bimekizumab is currently under review by the FDA and and EMA for the treatment of moderate to severe plaque psoriasis in adults.

UCB’s Bimekizumab almost entirely cleared moderate to severe psoriasis in more than 60 percent of the patients who took part in two Phase 3 clinical trials.

Given via injection under the skin, Bimekizumab is a monoclonal antibody and the first to block both Interleukin 17A and Interleukin 17F which are overexpressed in psoriasis. It is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of moderate to severe plaque psoriasis in adults.

The BE RADIANT study compared Bimekizumab with Secukinumab, an IL17 A blocker, and The BE SURE trial compared Bimekizumab with Adalimumab.

In both studies, Bimekizumab was given every 4 weeks for 16 weeks after which two maintenance schedules were possible: continue at every 4 weeks or go to an 8-week schedule .

The team assessed the efficacy of the treatments using the Psoriasis Area Severity Index (PASI) with PASI 100 indicating clear skin. At week 16 in the BE RADIANT trial, 230 patients (61.7%) on Bimekizumab reached complete  skin clearance (PASI 100) whereas only 181 (48.9%) on Secukinumab achieved the same result.

At week 16 in the BE SURE trial, 275 (86.2%) of the patients on Bimekizumab achieved a PASI 90, one of the primary endpoints of the study where only 75 of the patients on Adalimumab-(47.2%) had the same result. After approximately a year, there was no difference in outcomes for patients receiving Bimekizumab every 4 weeks, or every 8 weeks, the research showed.

Side effects were rare, though oral candidiasis occurred in some patients. The results are published in the New England Journal of Medicine and presented at at the American Academy of Dermatology Virtual Meeting Experience 2021.

“These trials show that Bimekizumab offers much hope to patients with moderate to severe psoriasis,” says BESURE study author Professor Richard Warren from The University of Manchester is also a Consultant Dermatologist at Salford Royal NHS Foundation Trust. “The higher rates of skin clearance under Bimekizumab compared with Secukinumab and Adalimumab were very impressive. This drug sets a new bar for psoriasis treatment and we are hopeful that trials in treating other diseases triggered by overactive Interleukin 17A and Interleukin 17F will also lead to improvements in patient care .”

Mark G. Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai in New York City, was one of the BERADIANT investigators. “Bimekizumab blocks IL-17A and IL17F, providing greater efficacy for psoriasis than nearly any other drug for psoriasis,” he says. “It is the first biologic to achieve PASI 100 at its primary endpoint in the majority of patients. It is fast and its effect continues with continued treatment even when the frequency of injections is reduced to every 8 weeks. Early data on psoriatic arthritis show greater degrees if improvement than have been seen with other biologics.”