Bimekizumab Demonstrates Sustained Reduction in Flares in Moderate to Severe HS Over 2 Years

Recent data from the BE HEARD EXT extension trial (NCT04901195) presented as a poster at the 2025 Fall Clinical Dermatology Conference in Las Vegas, Nevada, details the promising role of bimekizumab, a humanized monoclonal antibody targeting interleukin (IL)-17F and IL-17A pathways, in long-term hidradenitis suppurative (HS) management. This pivotal study pooled data from the core BE HEARD I (NCT04242446) and BE HEARD 2 (NCT04242498) trials and an ongoing extension phase, assessing the impact of bimekizumab on flare frequency over 2 years.¹

Authors Naik et al stressed the importance of reducing flares in patients with HS to achieve disease control and improve quality of life. Flare-ups, defined as exacerbations of lesions, are a hallmark feature, contributing to disease burden and complicating management strategies.

The study enrolled 1014 patients with moderate to severe HS, with 556 patients receiving bimekizumab and completing week 48 before entering the extension phase. Patients received open-label bimekizumab at either 320 mg every 2 weeks or every 4 weeks, with dose adjustments permitted based on clinical response.

The primary findings revealed that a significant majority of patients remained flare-free across the 2-year period. Specifically, at week 48, 83.8% (466/556) of patients reported no flares, a rate that was largely maintained through week 96, with 83.4% (372/446) remaining flare-free. Conversely, the proportion experiencing at least one flare during the observation period was minimal: only 2.2% at week 48 and 1.1% at week 96. These results are notable, indicating a sustained efficacy in preventing exacerbations.

According to the authors, this consistency in flare control over 2 years aligns with the primary goal of HS treatment—to stabilize disease activity and improve patient outcomes. The criteria for dose adjustments involved predefined reductions in lesion counts, allowing flexibility to optimize individual patient responses.

Overall, bimekizumab demonstrated a durable effect in maintaining flare-free status among patients with moderate to severe HS. Its dual inhibition of IL-17A and IL-17F may offer a valuable long-term therapeutic option, potentially transforming disease management paradigms.

Three-Year Data

Also recently, UCB presented 3-year safety and efficacy data from the BE HEARD 1 and 2 trials at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.²

"HS involves scarring, so there is a need to have effective medical therapy early in the disease course to prevent disease progression and scarring," said John Ingram, MA, MSc, DM, FRCP, FAcadMEd, professor of dermatology at Cardiff University, during the late-breaking presentation at EADV.

At 3 years, Hidradenitis Suppurativa Clinical Response (HiSCR) scores remained high, with 90.2% of patients maintaining HiSCR50, 81.2% maintaining HiSCR75, 64.3% maintaining HiSCR90, and 50.1% maintaining HiSCR100. Improvements in quality of life were also sustained: 38.1% of patients achieved a Dermatology Life Quality Index (DLQI) score of 0/1, indicating no impact of HS on daily life.

Safety findings were consistent with earlier years of study. Bimekizumab was generally well tolerated, with no new safety signals identified up to 3 years. The most common treatment-emergent adverse events included hidradenitis (19.6/100 patient years), coronavirus infection (14.1/100 PY), and oral candidiasis (9.3/100 PY).

References

1. Naik H, Daveluy S, Prens E, et al. Bimekizumab impact on flare hidradenitis suppurativa over 2 years: data from BE HEARD EXT. Presented at: 2025 Fall Clinical Dermatology Conference; October 23-26, 2025; Las Vegas, NV.
2. Ingram J. Bimekizumab efficacy and safety through 3 years in patients with hidradenitis suppurativa: results from the phase 3 BE HEARD I&II trials and their open-label extension BE HEARD EXT. Presented at: 2025 European Academy of Dermatology and Venerology Congress; September 17-20, 2025; Paris, France.