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Dual inhibition of interleukins by bimekizumab appears to be a promising
therapeutic approach for Hidradenitis suppurativa, with a good potential to
attain deep responses in the clinical outcomes.
In people diagnosed with moderate-to-severe Hidradenitis suppurativa, bimekizumab (a monoclonal IgG1 antibody that selectively suppresses interleukin 17A and 17F) showed remarkable improvements across all the outcome measures, including the stringent outcomes, as deciphered from a randomized clinical trial published in JAMA Dermatology. Researchers undertook this phase II, placebo-controlled, double-blind study (with an active reference arm) for determining bimekizumab's efficacy and safety for the management of Hidradenitis suppurativa.
This study incorporated a 2-4 week screening duration, a 12-week therapy duration, and a twenty-week safety follow-up. Out of 167 subjects screened, 90 subjects (age 18-70 years) with Hidradenitis suppurativa diagnosed 2 months or more prior to baseline were recruited. The subjects were randomly assigned to (i) Bimekizumab group (n=46, 640 mg at week 0, 320 mg every two weeks), (ii) placebo group (n=22), and (iii) reference arm adalimumab group (n=22, 160 mg at week 0, 80 mg at second week, and 40 mg every week for weeks 4-10).
The exploratory variables incorporated the percentage attaining a modified Hidradenitis Suppurativa Clinical Response [HiSCR] with 75% decline of HiSCR criteria (HiSCR75) or a modified HiSCR with 90% decline of HiSCR criteria (HiSCR90), Dermatology Life Quality Index (DLQI) scores, and alteration in pain. The percentage of people with a 50% or higher decline from the baseline in total abscess and inflammatory nodule count with no rise in abscess or draining fistula count (HiSCR) at the 12th week was the major efficacy endpoint.
In total, 88 people were administered at least 1 dose of study medication. The study, including the safety follow-up was completed by 79 people. At Week 12, a greater HiSCR rate and improvements in International Hidradenitis Suppurativa Severity Score (IHS4) were noted in the bimekizumab group vs. the placebo group, as shown in Table 1:
In comparison with placebo-treated people, bimekizumab-treated people showed higher clinical improvements and attained better positive results on stringent outcome measures. At week 12, the percentage of people attaining HiSCR75 and HiSCR90, and the occurrence of serious adverse events in the study groups are shown in Table 2.
Notably, 1 participant withdrew due
to noxious events. Bimekizumab's safety profile displayed consistency with the
studies of other indications, favoring additional research in Hidradenitis
suppurativa patients.
JAMA Dermatology
Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial
Sophie Glatt et al.
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