Bimekizumab-Related HS Improvements at 1 Year Sustained Up to 2 Years

Christos C. Zouboulis, MD, PHD

Credit: Global Melanoma Initiative

Clinically meaningful hidradenitis suppurativa (HS) improvements may be seen among patients with bimekizumab (Bimzelx) therapy over 1 year of treatment and then maintained up to 2 years, according to recent findings presented at the European Academy of Dermatology & Venereology (EADV) Congress in Amsterdam.¹

These recently-presented findings were presented by UCB, the global biopharmaceutical company and resulted from the BE HEARD trial program.

“Hidradenitis suppurativa is a chronic, relapsing and painful inflammatory skin disease that significantly impacts patients’ quality of life,” Christos C. Zouboulis, MD, PhD, the president of the European Hidradenitis Suppurativa Foundation (EHSF), said in a statement. “The bimekizumab data presented at EADV 2024 showed maintained improvements in clinical response, symptoms, severity and quality of life over two years.”

Hidradenitis Suppurativa

HS is an inflammatory skin disease which is long-term, painful, and debilitating involving systemic symptoms. The disease commonly results in flare-ups and is characterized primarily by the formation of abscesses, nodules, and tunnels that appear in regions such as the groin, armpits, and buttocks.

The condition typically becomes emergent in the early adulthood period and impacts close to 1% of the population in countries that have been studied. Those impacted by HS are often in significant pain, and these results can substantially affect their quality of life.

Study Design and Background

Bimekizumab, a dual interleukin (IL)-17A and IL-17F inhibitor, were evaluated by the investigators of BE HEARD I and II in adult individuals with moderate to severe HS. These studies were phase 3, randomized, multicenter, double-blind, placebo-controlled trials which involved the recruitment of 1,014 participants.

Patients were randomly assigned either to different bimekizumab dosing regimens or to the placebo arm over a 48-week time period. A total of 556 of the 1,014 involved participants who initially had been in the bimekizumab treatment arm finished up the 48-week study and enrolled in the open-label extension period. The team noted that 446 continued through to the 96-week mark.

The main goal of both studies was to assess HS Clinical Response 50 (HiSCR50). HiSCR50 was noted as being a 50% or greater reduction in the count of abscesses and nodules, without any increase in patients’ draining tunnels. The research team sought this finding by Week 16 and determined their secondary endpoint would be HiSCR75, requiring a 75% reduction within the same timeframe.

Major Findings

By the 96-week mark, the team reported that 85.4% of the subjects achieved HiSCR50, adding that a total of 77.1% were successful in achieving HiSCR75 and 44.2% in achieving HiSCR100 In terms of improvements in disease severity, the investigators noted that reductions in draining tunnels, and enhanced life quality were maintained over the 2-year treatment period.

Overall, these findings on disease severity improvements had been measured by the International HS Severity Score System (IHS4). The aforementioned improvements in subjects’ health-related quality of life were measured by the Dermatology Life Quality Index (DLQI), and these persisted through the 2-year period, with 1 in 3 individuals reporting minimal to no effects from the disease.

The drug was also found to be well-tolerated over 2 years, with the investigators finding no new safety signals among those involved in the study. Out of 995 patients who received at least a single bimekizumab dose, 917 experienced treatment-emergent adverse events (TEAEs), with serious TEAEs being seen among 122. The most frequent side effects were shown to be coronavirus infection, hidradenitis, and oral candidiasis.

“These findings are particularly encouraging given the need for new treatment options that offer sustained relief for patients,” Zouboulis and colleagues wrote.

References

1. ^{UCB announces late-breaking two-year data for BIMZELX[®] (bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024. September 27, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-late-breaking-two-year-data-for-BIMZELXRVbimekizumab-in-moderate-to-severe-hidradenitis-suppurativa-at-EADV-2024. Date accessed: October 1, 2024.}