Bimekizumab shows long-term efficacy in hidradenitis suppurativa


By Michael Woodhead

13 Mar 2024

Patients with hidradenitis suppurativa treated with the interleukin-17 A and F antagonist bimekizumab-bkzx (Bimzelx) showed clinically meaningful improvements in skin pain up to 48 weeks, according to results released at AAD 2024.

Post-hoc analyses of pooled Phase 3 data from the BE HEARD I and BE HEARD II studies showed that bimekizumab produced sustained improvements in skin pain and draining tunnels compared to placebo in adults with moderate-to-severe hidradenitis suppurativa (HS).

In the study, 1014 patients were randomised to receive either bimekizumab 320 mg every two weeks, four weeks or placebo.

The results showed that patients treated with bimekizumab reported clinically meaningful improvements in skin pain up to 48 weeks across various assessed outcomes, including the HS Symptom Questionnaire (HSSQ) skin pain item, the Patient Global Impression of Severity of Skin Pain (PGI-S-SP) and the Change in Severity of Skin Pain (PGI-C-SP).

At Week 48, HSSQ skin pain response was achieved by 64.6–75.7% of patients and a HSSQ skin pain score of 0 was achieved by 12.7–19.8% of patients. Skin pain scores reduced by 36.9–43.7% across treatment groups.

Additionally, patients treated with bimekizumab demonstrated greater reductions in draining tunnel count compared to those on placebo at Week 16. Responses were either sustained or improved to Week 48.

At week 16, the draining tunnel percent change from baseline was higher with bimekizumab vs. placebo (-43.9% to -45.7% vs -21.5%). The bimekizumab-treated patients also saw greater absolute changes in draining tunnel count vs. placebo. The percentage and absolute change from baseline increased through Week 48 across all bimekizumab groups.

At week 16, greater proportions of bimekizumab-treated patients saw draining tunnel reductions of three or more vs. those on placebo (58.0%–70.6% vs 35.0%), with responses sustained or improved to Week 48 across regimens (79.4%–88.7%).

“The majority of patients with hidradenitis suppurativa experience disease-associated pain that can impact their quality-of-life. Data from the Phase 3 studies show that after 48 weeks of bimekizumab treatment approximately six out of ten patients rated their skin pain ‘much better’,” said study investigator Associate Professor Hadar Lev-Tov of the Department of Dermatology and Cutaneous Surgery, University of Miami, Florida.

“These long-term results are encouraging, especially given that pain is a common complaint in people with HS that dermatologists struggle with daily.”

The IL-17 monoclonal antibody is currently approved for the treatment of psoriasis in the US and study sponsor UCB said it is now pursuing regulatory applications across the globe to have bimekizumab approved for patients with hidradenitis suppurativa.

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