Phase 3 Data on Bimekizumab for Hidradenitis Suppurativa Show Meaningful Improvements

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The findings from these 2 trials for bimekizumab may lead to greater treatment options for patients with HS, an often debilitating and chronic skin condition.

Clinically-meaningful improvements in moderate-to-severe hidradenitis suppurativa (HS) may be seen among individuals treated with bimekizumab (Bimzelx), according to new data announced by UCB at the 2023 European Academy of Dermatology and Venereology (EADV) Congress in Berlin.1,2

Bimekizumab is humanized monoclonal IgG1 antibody which is used to selectively-inhibit interleukin 17A (IL-17A) and selectively inhibit IL-17F, known to be pivotal cytokines that play a major role in driving inflammatory processes in the human body.

The newly-announced findings on bimekizumab resulted from two phase 3 clinical trials—titled BE HEARD I and BE HEARD II—which incorporated several clinical endpoints such as HS Clinical Response (HiSCR)-75, HiSCR90, and HiSCR100, in addition to the standard HiSCR50.

“In these studies, bimekizumab demonstrated clinical meaningful improvements for these outcomes over placebo at Week 16, with improvements increasing for patients remaining in the studies through Week 48,” Christos C. Zouboulis, Md, PhD, President of the European Hidradenitis Suppurativa Foundation and founding professor of dermatology and venereology at the Brandenburg Medical School, said in a statement.

The BE HEARD I and BE HEARD II trials were phase 3, randomized, double-blind, multicenter, placebo-controlled, parallel group studies that were conducted to assess the efficacy and the safety of bimekizumab in adults. Both of the trials collectively recruited 1,014 subjects who had all been diagnosed with moderate-to-severe forms of HS.

The investigators’ primary endpoint that was used for both studies centered on assessing HiSCR50 at the 16-week mark, and a pivotal secondary endpoint used by the team was the assessment of HiSCR75 at the same point. Both HiSCR50 and HiSCR75 are known to be characterized by a minimum of 50 or 75% reduction from the point of baseline as far as total abscesses and total inflammatory nodules.

The investigators pooled the BE HEARD I and II data, including an initial 0–16 weeks and the later maintenance treatment period going from Week 16 to 48. They randomized the subjects 2:2:2:1 (initial/maintenance) to be given 320 mg every 2 weeks (Q2W) /Q2W, or Q2W/every 4 weeks (Q4W), or Q4W/Q4W, or placebo/bimekizumab Q2W.

Subjects treated with the drug were found to have shown higher response rates for the primary endpoint of HiSCR50 at 16 weeks compared to those in the placebo arm. The investigators also observed that those who switched from the placebo to the drug at 16 weeks had a response that approached that reached by individuals on the treatment from baseline.

The research team noted that across each of the groups that had been treated, over 80% of subjects who had reported HiSCR50 at 16 weeks were shown to have maintained their response through to the 48-week mark. Furthermore, over all of the treatment groups, more than 80% of subjects who reported an abscess and inflammatory nodule (AN) count of 0, of 1, or of 2 at the point of 16 weeks were found to have maintained the response up to the 48-week mark.

The team noted that the greater proportion of subjects receiving a clinical response by Week 16, compared to placebo, was shown to be the case regardless of participants’ weights and body mass index category. The team added that they saw increasing levels of such responses between Week 16 and Week 48 in the study population.

The safety profile of the drug in the BE HEARD I and BE HEARD II trials was shown by the investigators to have remained consistent with prior research, with the team noting no new safety problems. The most commonly-recorded treatment-emergent adverse events (AEs) included oral candidiasis, hidradenitis, and COVID-19 infections.

Serious treatment-emergent AEs were reported by the team in varying percentages over different dosing regimens of the drug.

The investigators also added that the safety and the efficacy of bimekizumab for HS patients have both not yet been fully established, adding that the drug has not received approval for its use among those with HS by any regulatory authority worldwide.

References

  1. Phase 3 Data Analysis Presented at EADV 2023 Showed Bimekizumab Achieved High Thresholds of Clinical Response in Hidradenitis Suppurativa. UCB. October 12, 2023. Date accessed: October 12, 2023. https://www.prnewswire.com/news-releases/phase-3-data-analysis-presented-at-eadv-2023-showed-bimekizumab-achieved-high-thresholds-of-clinical-response-in-hidradenitis-suppurativa-301955218.html.
  2. Kimball A, et al. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicenter studies. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17 – 21. New Orleans, LA. Accessed March 20, 2023.
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