A multi-centre phase 3 clinical trial found that the novel biologic might be a more effective alternative to current drugs in the treatment of moderate to severe psoriasis.
The novel biologic might be a more effective alternative to current drugs in the treatment of moderate to severe psoriasis.
The 52-week long, multicentre, randomised, double-blind, phase 3 BE VIVID trial compared bimekizumab to ustekinumab and placebo. Bimekizumab differs from other currently available anti-interleukin drugs by selectively targeting IL-17F and IL-17A, which are both over-expressed in psoriasis.
The results of the trial, recently published in The Lancet, suggest that bimekizumab might be a safe and more effective treatment for plaque psoriasis than both ustekinumab and placebo.
The study included 567 patients with moderate to severe plaque psoriasis recruited at 105 locations across 11 countries, including Australia. Participants were stratified by geographical region and previous exposure to biologics and randomly assigned to receive bimekizumab, ustekinumab or placebo. At week 16, patients receiving placebo switched to bimekizumab.
At week 16, 85% of the bimekizumab group participants had a 90% improvement in Psoriasis Area Severity Index score (PASI 90) compared with 50% in the ustekinumab group and 5% in the placebo group. PASI 100 was observed in 59% of patients in the bimekizumab group, 21% of those in the ustekinumab group and none of those in the placebo group. The safety profile of bimekizumab was consistent with that in previous studies.
“It is one of the first phase 3 studies with bimekizumab, a monoclonal antibody with a novel mechanism of action – the blockade of both IL-17 A and IL-17 F,” said Professor Kristian Reich, consultant dermatologist at the Institute for Health Services Research in Dermatology and Nursing at the University Medical Center, Germany, and one of the authors of the study.
“The study shows some of the highest responses ever seen in a phase 3 trial in psoriasis and an impressive superiority of bimekizumab over the IL-12/23 inhibitor ustekinumab,” he said.
Currently approved biological therapies include TNF inhibitors and IL-12/23, IL-17, and IL-23 inhibitors. These are effective treatments for moderate to severe psoriasis, but a proportion of patients do not have a rapid and complete skin clearance that is maintained over time.
“Blockade of IL-17 A and F seems to provide not only a very fast onset of response but also very high response levels in patients with moderate-to-severe plaque psoriasis, further raising the bar of patient care in this indication,” said Reich.
“If these results translate to psoriatic arthritis as well as psoriasis, we will have some great options in the future,” said rheumatology professor Graeme Jones, Head of the Musculoskeletal Research Group at the Menzies Institute for Medical Research in Tasmania.
Bimekizumab is not yet approved by any national regulatory authority, but its approval is expected this year.
