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Bimekizumab meets primary, secondary endpoints in phase 3 psoriasis study
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UCB announced positive results from BE READY, the second of three phase 3 studies to report on bimekizumab this year.
“Bimekizumab blocks both interleukin-17A and IL-17F, unlike drugs such as ixekizumab (Taltz, Lilly) and secukinumab (Cosentyx, Novartis) that block only IL-17A,” study investigator Andrew Blauvelt, MD, MBA, president of Oregon Medical Research Center in Portland, told Healio Dermatology.
Bimekizumab was statistically superior to placebo in achieving total skin clearance, achieving Psoriasis Area and Severity Index (PASI) 100 at week 16. Bimekizumab was also superior to placebo in achieving rapid response defined as PASI 75 at week 4.
After the initial week 16 response, for the randomized withdrawal period, continued bimekizumab resulted in a statistically superior response at week 56.
The safety and efficacy of bimekizumab in adult patients with chronic plaque psoriasis was explored in BE READY, the 56-week phase 3 study that was randomized, double-blind and placebo-controlled with an initial treatment period followed by a randomized withdrawal period, according to the UCB press release. A total of 435 participants were enrolled with chronic plaque psoriasis for at least 6 months before screening and with an affected body surface area of at least 10% and PASI of at least 12.
“Phase 3 data are now emerging for bimekizumab in the form of several ‘positive’ news releases, but details on the actual efficacy numbers have not yet been presented,” Blauvelt said. “Based upon very impressive phase 2 efficacy results for bimekizumab, it is expected that the phase 3 results will be similarly impressive, and likely better than efficacy results that we have seen with other biologics for psoriasis.”
Additional findings include bimekizumab superiority to placebo in patient-reported reductions in itch, pain and scaling as well as clear or almost clear scalp at week 16.
The safety profile for bimekizumab was similar to earlier clinical studies, according to the release.
These data follow the positive clinical results from the phase 3 BE VIVID study, which evaluated bimekizumab vs. placebo and Stelara (ustekinumab, Janssen) in adults with psoriasis. The full results from BE READY will be presented at a scientific congress in 2020, according to the release. – by Abigail Sutton
Disclosure: Blauvelt is lead study investigator for this study.