A novel drug almost entirely cleared moderate to severe psoriasis in over 60% of the patients who took part in two phase three clinical trials of a new drug.
The University of Manchester and Salford Royal NHS Foundation Trust led studies on Bimekizumab , both published in the prestigious New England Journal of Medicine today, were funded by UCB Pharma; the company that developed the treatment which could be available in as little as 12 months.
Given as an 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.
Interleukin 17A and Interleukin 17F are two types of special proteins called cytokines which regulate the immune system. Other psoriasis drugs have only been able to block 17A.
One trial called BE RADIANT, compared the drug with Secukinumab, an IL17 A blocker: 743 patients were enrolled and 373 patients were assigned to Bimekizumab
The BE SURE trial compared Bimekizumab with Adalimumab: of the 478 patients enrolled, 319 patients were assigned to Bimekizumab.
Bimekizumab in both studies 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 .
Secukinumab and Adalimumab were given as per label.
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 or 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.
Side effects were rare, though oral candidiasis- usually an easily treatable mouth infection – occurred in some patients.
Professor Richard Warren from The University of Manchester is also a Consultant Dermatologist at Salford Royal NHS Foundation Trust.
He has been leading some parts of the Bimekizumab development programme over the last 5 years as well as working with others on the design of the phase 3 programmes.
He said: “These trials show that Bimekizumab offers much hope to patients with moderate to severe psoriasis.
“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 over active Interleukin 17A and Interleukin 17F will also lead to improvements in patient care .”
The papers Bimekizumab versus Adalimumab in Plaque Psoriasis and Bimekizumab versus Secukinumab in Plaque Psoriasis are published in New England Journal of Medicine