BE HEARD: Bimekizumab Benefit in Hidradenitis Suppurativa Persists for 3 Years

Use of bimekizumab (Bimzelx) for hidradenitis suppurativa (HS) was associated with disease control lasting up to 3 years, according to new data from the European Association of Dermatology and Venereology (EADV) 2025 Congress.

An analysis of data from the BE HEARD trial program, results demonstrate improvements seen in Hidradenitis Suppurativa Clinical Response (HiSCR) 75, HiSCR90, and HiSCR100 were sustained out to 3 years, with the EADV Congress presentation also shedding light on other key efficacy and safety outcomes from the trials.1

“A crucial goal for treating people with hidradenitis suppurativa is achieving and maintaining long term disease control at the most stringent levels,” said study presenter John Ingram, DM, MSc, MA, professor of Dermatology at Cardiff University.1 “These data for bimekizumab – including HiSCR100 and IHS4-100 – showed disease control can be maintained long-term. Importantly, the resolution of inflammatory lesions highlights the potential to prevent long-term structural damage commonly associated with this disease.”

Billed as the first medicine approved to selectively inhibit both interleukin 17A and interleukin 17F, bimekizumab received approval for treatment of HS in 2024 based on the BE HEARD program. Prior to 2024, the agent had received approvals for psoriatic arthritis and psoriasis in 2024 and 2023, respectively.1 ,2

The BE HEARD program consisted of 2 phase 3 trials: BE HEARD I and BE HEARD II. Between the trials, more than 1000 patients were randomized 2:2:2:1 to bimekizumab 320 mg every 2 weeks, 4 weeks, or a combination.

Per trial design, those who participated through 48 weeks were invited to participate in an open-label extension period. Of 1014 patients enrolled in the trials, 556 patients received bimekizumab in BE HEARD I and II completed week 48. Of these, 446 patients in the open-label extension study completed week 96 and 367 completed week 148.

Data highlighted at EADV included the following results:

• HiSCR responses at 3 years: HiSCR50 achieved in 90.2%, HiSCR75 in 81.2%, HiSCR90 in 64.3%, and HiSCR100 in 50.1%.
• Quality of life (DLQI 0/1): 27.4% at year 1 improved to 38.1% at year 3.
• International Hidradenitis Suppurativa Severity Score (IHS) 4 responses at 2 years: Among those with responses at week 48, 90.8% maintained IHS4-55, 85.1% IHS4-75, 71.2% IHS4-90, and 64.3% IHS4-100.

Safety data indicated treatment was generally well tolerated, with no new safety signals observed up to 3 years and the overall safety profile up to 3 years consistent with years 1 and 2. The most common treatment-emergent adverse events were hidradenitis (19.6/100 patient years [PY]), coronavirus infection (14.1/100 PY), and oral candidiasis (9.3/100 PY).1

“The 3-year data on bimekizumab presented at EADV demonstrated deep and sustained responses across stringent efficacy endpoints, as well as long-term improvements in health-related quality of life – raising the treatment bar for people living with hidradenitis suppurativa,” said Donatello Crocetta, head of Medical and Chief Medical Officer, UCB.1 “Long-term efficacy and safety data are vital for advancing understanding of chronic inflammatory conditions like hidradenitis suppurativa, and these findings underscore UCB’s commitment to advancing science-led insights and providing transformative treatment options to improve outcomes for patients.”

References:

1. UCB. BIMZELX[®]▼(bimekizumab) new three-year data in hidradenitis suppurativa at EADV showed sustained disease control across the most stringent clinical endpoints | UCB. Ucb.com. Published September 17, 2025. Accessed September 17, 2025. https://www.ucb.com/newsroom/press-releases/article/bimzelxrvbimekizumab-new-three-year-data-in-hidradenitis-suppurativa-at-eadv-showed-sustained-disease-control-across-the-most-stringent-clinical-endpoints

2. UCB. UCB receives U.S. FDA approval for BIMZELX[®] (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa | UCB. Ucb.com. Published November 20, 2024. Accessed September 17, 2025. https://www.ucb.com/newsroom/press-releases/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa