Bimekizumab-Treated Patients With Hidradenitis Suppurativa Remained Flare-Free Through 3 Years in Extension Study
Key Takeaways
- At week 148, 86.1% (316/367) of evaluable bimekizumab-treated patients had no observed flare at any scheduled visit through that timepoint.
- No patients with available data at week 148 (0/367) had a flare at that visit; this differs from the cumulative flare-free measure.
- Observed-case analyses and attrition (189 patients did not complete weeks 48–148) limit interpretation of long-term durability.
Most evaluable patients with moderate-to-severe hidradenitis suppurativa (HS) receiving bimekizumab remained free of observed flares through 148 weeks, according to pooled BE HEARD I and II and BE HEARD EXT data presented at the 2026 Fall Clinical Dermatology Conference.
The analysis included 556 patients originally randomized to bimekizumab 320 mg in the phase 3 BE HEARD studies who completed week 48 and entered the open-label extension. Of these, 303 had baseline Hurley stage II disease and 253 had stage III disease. Mean age was 36.3 years, and 53.8% were women.
Investigators defined a flare as at least a 25% increase in abscess and inflammatory nodule count from baseline, with an absolute increase of at least two lesions. Outcomes were assessed at scheduled visits and reported using observed-case analyses.
Flare-Free Outcomes Through Week 148
The cumulative proportion without an observed flare at any visit was 83.8% (466/556) at week 48, 83.7% (374/447) at week 96, and 86.1% (316/367) at week 148. At the final visit, the corresponding proportions were 86.6% (175/202) for baseline Hurley stage II and 85.5% (141/165) for stage III.
The proportion experiencing a flare at an individual visit declined from 2.2% (12/556) at week 48 to 0.9% (4/447) at week 96 and 0% (0/367) at week 148. Numerically lower flare rates were observed in the Hurley stage II group through the first year.
The findings warrant caution: 189 patients did not complete the extension between weeks 48 and 148, including 23 who withdrew because of lack of efficacy. Patients with more flares may have been more likely to discontinue, potentially affecting observed-case estimates.
“Most patients treated with bimekizumab who stayed in the study remained flare-free at all visits through 3 years,” the investigators concluded.
- Daveluy S, Naik HB, Reguiai Z, et al. Bimekizumab leads to sustained flare-free status in moderate to severe hidradenitis suppurativa: 3-year data from BE HEARD EXT. Poster presented at: Fall Clinical Dermatology Conference 2026; October 8-11, 2026; Las Vegas, NV. Previously presented at AAD 2026.