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BE HEARD: Bimekizumab 3-Year Data Support Earlier Intervention HS, With Raj Chovatiya, MD, PhD
Extension data from BE HEARD showed that patients with shorter disease duration and lower baseline severity achieved higher response rates than those with longstanding, more severe disease.
Patients with moderate hidradenitis suppurativa (HS) and shorter disease duration demonstrated substantially greater clinical improvement over 3 years of bimekizumab (Bimzelx) treatment than those with severe, longstanding disease — findings that Raj Chovatiya, MD, PhD, MSCI, argues reinforce the urgency of early therapeutic intervention in a condition defined by diagnostic delay.
Chovatiya, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago, Illinois, presented a post hoc analysis of the BE HEARD extension study (BE HEARD EXT) at the 2026 American Academy of Dermatology (AAD) Annual Meeting held in Denver, Colorado, from March 27-31. The BE HEARD program comprised 2 multicenter, randomized, double-blind, placebo-controlled phase 3 trials (BE HEARD I and II) with a combined enrollment of 1,014 participants evaluating bimekizumab — a dual IL-17A and IL-17F inhibitor — in adults with moderate to severe HS. Patients who completed Week 48 were eligible to enroll in BE HEARD EXT, an open-label extension in which participants received bimekizumab 320 mg subcutaneously every 2 or 4 weeks based on response. The analysis reported at the meeting reflects observed-case data from the 367 patients randomized to bimekizumab from baseline in BE HEARD I and II who completed BE HEARD EXT through Week 148.
The post hoc analysis stratified patients by disease duration quartile and baseline Hurley stage. Among patients in the lowest disease duration quartile (less than 2.38 years since HS diagnosis) with moderate baseline disease (Hurley Stage II), HiSCR90 and HiSCR100 at 3 years were achieved by 74.1% (43/58) and 62.1% (36/58), respectively. By contrast, patients in the highest disease duration quartile (10.74 or more years) with severe baseline disease (Hurley Stage III) achieved HiSCR90 and HiSCR100 at rates of 51.5% (17/33) and 33.3% (11/33), respectively. This separation across response thresholds was sustained across the full 3-year treatment period. In a separate post hoc analysis of the same extension dataset, 86.1% (316/367) of patients who completed Week 148 remained free of acute symptom exacerbation — defined as a 25% or greater increase in abscess and inflammatory nodule count from baseline with an absolute increase of 2 or more — at any scheduled clinic visit through 3 years. Bimekizumab also demonstrated efficacy improvements across all evaluated subgroups in a third post hoc analysis, including by age, sex, BMI, baseline disease duration, and Hurley stage.
In his conversation with HCPLive, Chovatiya noted that the concept of a window of opportunity in HS — in which earlier intervention may limit irreversible structural damage — has been theorized but difficult to test prospectively given the challenges of enrolling patients early in the disease course. He characterized this analysis as among the first to operationalize that question using clinical trial data, and expressed interest in seeing analogous analyses conducted across other approved mechanisms, including oral JAK inhibitors and agents targeting the IL-1 family and chemokine pathways, as the HS pipeline continues to expand. These data were post hoc analyses and should be interpreted with caution as the analyses were not prespecified in the original protocols.
“We talk about this window of opportunity with HS all the time, that if we can intervene early enough, can we change the course of disease and limit any functionally impairing outcomes? And this is really the first step in analyses that really try to take a look at individuals that are in the early parts of their disease and see what their overall trajectory looks like,” Chovatiya said.
Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.
References
Chovatiya R. Bimekizumab efficacy by disease duration and severity in moderate to severe hidradenitis suppurativa: 3-year phase 3 results from BE HEARD EXT. 2026. AAD. #73498.
UCB. UCB announces new BIMZELX® (bimekizumab-bkzx) data at AAD showing durable symptom control throughout three years in hidradenitis suppurativa. Press release. March 27, 2026. Accessed [date]. https://www.ucb.com/newsroom/press-releases/article/ucb-announces-new-bimzelxr-bimekizumab-bkzx-data-at-aad-showing-durable-symptom-control-throughout-three-years-in-hidradenitis-suppurativa
Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-2519.
