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A novel drug has almost completely eliminated moderate to severe psoriasis in over 60% of patients who participated in two Phase 3 clinical trials of a new drug.
The studies of bimekizumab conducted by the University of Manchester and the Salford Royal NHS Foundation Trust, both published today in the prestigious New England Journal of Medicine, were funded by UCB Pharma. the company that developed the treatment that could be available in just 12 months.
Bimekizumab, given as an injection under the skin, is a monoclonal antibody that is the first to block both interleukin 17A and interleukin 17F, which are overexpressed in psoriasis.
Interleukin 17A and Interleukin 17F are two types of special proteins called cytokines that regulate the immune system. Other psoriasis drugs could only block 17A.
A study called BE RADIANT compared the drug with secukinumab, an IL17 A blocker: 743 patients were enrolled and 373 patients were assigned to bimekizumab
In the BE SURE study, bimekizumab was compared with adalimumab: 319 of the 478 patients included were treated with bimekizumab.
Bimekizumab was given every four weeks for 16 weeks in both studies. After that, two maintenance plans were possible: continue every four weeks or switch to an 8-week plan.
Secukinumab and adalimumab were given as labeled.
The team evaluated the effectiveness of the treatments using the Psoriasis Area Severity Index (PASI), with PASI 100 indicating clear skin.
At week 16 of the BE RADIANT study, 230 patients (61.7%) achieved complete skin clearance (PASI 100) on bimekizumab, while only 181 (48.9%) achieved the same result on secukinumab.
At Week 16 of the BE SURE study, 275 or 86.2% of patients on bimekizumab achieved a PASI 90, a primary endpoint of the study where only 75 of the patients on adalimumab (47.2%) achieved the same result.
After approximately one year, there was no difference in results for patients who received bimekizumab every 4 weeks or every 8 weeks.
Side effects were rare, although some patients experienced oral candidiasis – usually an easily treatable mouth infection.
Professor Richard Warren of the University of Manchester is also a consulting dermatologist with the Salford Royal NHS Foundation Trust.
For the past five years he has led some parts of the bimekizumab development program and worked with others to design the phase 3 programs.
He said, "These studies show that bimekizumab offers great hope for patients with moderate to severe psoriasis.
"The higher skin clearance rates with bimekizumab compared to secukinumab and adalimumab were very impressive.
"This drug sets a new standard for the treatment of psoriasis, and we hope that trials of other diseases caused by overactive interleukin 17A and interleukin 17F will also improve patient care."
The articles Bimekizumab versus Adalimumab in "Plaque Psoriasis" and "Bimekizumab versus Secukinumab in Plaque Psoriasis" are published in the New England Journal of Medicine.
Bimekizumab better than ustekinumab for plaque psoriasis
Richard B. Warren et al. Bimekizumab versus adalimumab for plaque psoriasis, New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2102388
Kristian Reich et al. Bimekizumab versus secukinumab in plaque psoriasis, New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2102383
University of Manchester
New drug is game changer in psoriasis treatment (2021, April 26)
accessed on April 26, 2021
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