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New psoriasis injection bests secukinumab, adalimumab in separate tests

Journal
The New England Journal of Medicine
Reuters Health - 23/04/2021 - In patients with moderate-to-severe plaque psoriasis, bimekizumab therapy clears lesions more effectively that either adalimumab or secukinumab, according to results of the BE RADIANT and BE SURE clinical trials.

Both studies, published in the New England Journal of Medicine, were funded by Brussels-based UCB Pharma. The experimental humanized monoclonal IgG1 antibody inhibits two cytokines, IL-17A and IL-17F, that help drive inflammation.

In the BE RADIANT phase-3b study, 373 patients received 320 mg subcutaneous injections of bimekizumab every four weeks while 370 were given 300 mg injections of secukinumab weekly for four weeks, followed by injections of secukinumab every four weeks.

After just four weeks, 71% of bimekizumab patients saw a 75% reduction in the severity of their condition based on the 73-point Psoriasis Area and Severity Index (PASI) scale. In contrast, 47% of secukinumab recipients had a comparable reduction.

By the 16th week, 62% in the bimekizumab group saw a 100% reduction in their plaques compared with 49% of secukinumab patients. At week 48, the figures were 67% versus 46.2%, respectively.

Bimekizumab was judged superior (P<0.001) to secukinumab, which is sold under the brand name Cosentyx by Novartis. Both are anti-IL-17 treatments.

Bimekizumab "is the first biologic to achieve PASI 100 as 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," said coauthor Dr. Mark Lebwohl, dean for clinical therapeutics at the Icahn School of Medicine at Mount Sinai in New York City.

The larger BE SURE phase-3 study gave bimekizumab at the same dose to 158 patients but in another 161 volunteers, the researchers throttled back administration to every eight weeks beginning at week 16 and lasting to week 56. A third group, with 159 subjects, received subcutaneous adalimumab at a dose of 40 mg every two weeks for 24 weeks before they were switched to bimekizumab every four weeks until the end of the 56-week trial.

As in BE RADIANT, all participants had been plagued by plaque psoriasis for at least six months and scored at least a 3 on the 5-point Investigator's Global Assessment (IGA) scale, where higher numbers reflected more severity.

The target goal with BE SURE was a reduction of at least 90% in a patient's PASI score. At week 16, that occurred in 86% of the bimekizumab recipients and 47% of those treated with adalimumab, making bimekizumab superior (P<0.001).

In addition, 85% treated with bimekizumab and 57% given adalimumab therapy had clear or almost-clear skin on the IGA at week 16.

Adalimumab, a TNF inhibitor, is sold under the brand name Humira by AbbVie.

However, the BE RADIANT research team, led by Dr. Kristian Reich of the University Medical Center Hamburg-Eppendorf, found that bimekizumab seemed to increase the risk of oral candidiasis more than six-fold, to 19%, versus 3% with secukinumab. The cases were typically mild or moderate.

BE SURE patients getting bimekizumab had an oral candidiasis rate of 11% compared with no cases in the adalimumab group during the first 24 weeks of therapy, according to that team, led by Dr. Richard B. Warren of the University of Manchester.

Diarrhea was also more common during the first 24 weeks in the patients assigned to bimekizumab.

Preliminary BE RADIANT results were released July 24. BE SURE preliminary findings were released December 6, 2019, and detailed results were released October 31.

The earlier BE VIVID trial, published in The Lancet, showed that bimekizumab was superior to Johnson and Johnson's Stelara (ustekinumab).

SOURCES: https://bit.ly/3grxN4e and https://bit.ly/32uzXYD The New England Journal of Medicine, online April 23, 2021.

By Reuters Staff



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