Full clearance rates were substantially higher with bimekizumab a phase 3 test with 743 patients with moderate to severe plaque psoriasis, But oral candidiasis (oral thrush) arose again as a particular problem with the agent.
Clinical improvements seen with bimekizumab have outpaced those with two standard options for adult plaque psoriasis: the tumor necrosis factor blocker adalimumab and the interleukin (IL) inhibitor 12/23 ustekinumab – In phase 3 trials of the manufacturer UCB Pharma, and is in the process of being revised for indication by the US Food and Drug Administration and the European Medicines Agency.
Results of the trial comparing bimekizumab with secukinumab, bent BE RADIANT, were presented at the American Academy of Dermatology Virtual Meeting Experience and published online simultaneously on April 23 at New England Journal of Medicine.
The results “suggest that inhibition of both interleukin-17A and interleukin-17F with bimekizumab may provide greater clinical benefit for patients with moderate to severe plaque psoriasis than inhibition of interleukin-17A alone.” , as with secukinumab, the researchers said. per Kristian Reich, MD, professor of dermatology at the Hamburg-Eppendorf University Medical Center in Hamburg, Germany.
The trial randomly assigned 373 adults to bimekizumab 320 mg every 4 weeks at week 16, and then rearranged them to maintenance doses every 4 weeks or every 8 weeks at week 48; another 370 adults were randomly assigned to 300 mg secukinumab weekly for the first 4 weeks, then every 4 weeks at week 48. Baseline Psoriasis and Severity Index (PASI) scores were about 20 points in both treatment groups.
At one point in the month, 71% of the group with bimekizumab, compared with 47.3% of secukinumab, had a 75% or greater reduction from baseline PASI score. At 4 months, 61.7% of those taking bimekizumab but 48.9% of the secukinumab group had a complete clearance with a PASI score of 100.
At 48 weeks, 67% of those taking bimekizumab had a PASI 100 response, which was numerically similar between the two bimekizumab dosing regimens after week 16, compared with 46.2% in the secukinumab group (Pg for all <.001).
The incidence of serious adverse events was just under 6% in both groups, with adverse events leading to discontinuation in 3.5% of bimekizumab and 2.7% of subjects with secukinumab. The rate of serious infections was similar in both groups.
However, as in previous tests, orally candidiasis was a problem, which occurred in 19.3% of subjects with bimekizumab versus 3% of secukinumab. Half of the 72 cases of bimekizumab were classified as mild and all but two were moderate. More than 40% of affected subjects reported more than one case, but none caused treatment to be discontinued.
More than 85% of the study’s oral candidiasis cases were treated with antifungal therapy and resolved during the trial.
Inflammatory bowel disease is a concern about IL-17 blockade, but this has not emerged as a particular problem with bimekizumab. There was one case each ulcerative colitis in both the bimekizumab and secukinumab groups, and only one case of ulceration colitis in three previous phase 3 trials with bimekizumab, according to the researchers.
Trial limitations: Patients who had previously been on bimekizumab or secukinumab were excluded, as well as patients who had no response to a biological IL-17 or more than one biological agent of any other class during the 12 weeks. previous. Limitations could reduce generalization, the researchers said.
Patients in the trial were about 45 years old, on average, and about two-thirds were men; more than 90% were white.
The study was funded by UCB Pharma. The researchers had numerous disclosures, including the Reich, which reported grants and personal fees from companies such as UCB Pharma. The full list of disclosures can be found in the New England Journal of Medicine article.
Experience of virtual meetings of the American Academy of Dermatology: presented on April 23, 2021.
N Engl J Med. Published online April 23, 2021. Summary
M. Alexander Otto is an assistant physician with a master’s degree in medical sciences and a Newhouse degree in journalism from Syracuse University. He is an award-winning medical journalist who worked for McClatchy and Bloomberg before joining Medscape, and also a member of the MIT Knight Science Journalism. Email: [email protected]