Patients with hidradenitis suppurativa (HS) often wait years between symptom onset and diagnosis, a delay linked to greater structural damage and reduced treatment response.¹ Whether earlier systemic therapy can change this trajectory has remained largely theoretical, since designing a prospective trial around disease duration is impractical. Bimekizumab, a dual interleukin-17A and interleukin-17F inhibitor, is approved for moderate to severe HS in adults.²
Raj Chovatiya, MD, PhD, MSCI, is 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. He co-authored a post hoc analysis addressing the earlier-intervention question using existing trial data from the BE HEARD program.
Researchers pooled data from the phase 3 BE HEARD I and BE HEARD II trials of bimekizumab in moderate to severe HS, along with their open-label extension, BE HEARD EXT.³ Patients were stratified by disease duration quartile, with the shortest quartile including those diagnosed less than 2.38 years earlier and the longest quartile including those diagnosed 10.74 years or more earlier.²
By week 96, patients in the shortest-duration quartile reached an IHS4-100 response of 46.1% (53/115), versus 22.8% (23/101) among patients in the longest-duration quartile.² The separation between quartiles widened at each successive response threshold, from IHS4-55 through IHS4-100, and was most pronounced at the strictest benchmarks.² Response rates improved or held steady in both groups between week 48 and week 96, indicating durability rather than an early plateau.²
In the following interview, Chovatiya discusses how the quartile analysis was constructed and what the widening gap in response rates suggests about timing of systemic therapy in HS.
HCPLive: What did this pooled 2-year analysis set out to examine, and why is disease duration quartile a meaningful way to assess bimekizumab in HS?
Chovatiya: At this point, we've seen a lot of different pieces of the overall bimekizumab data package as it relates to HS. But some of the big questions we have in this inflammatory disease are: if we're able to treat earlier, during this hypothetical window of opportunity, can we change the course of disease, or have higher-level outcomes for our patients? It's with this idea that this analysis was undertaken. Of course, it's challenging to design a real study to answer that question, since it might take many years and a large number of patients.
But this was a post hoc analysis trying to take a look at patients who were on medication for about 2 years, the initial 1 year of the pivotal study as well as the initial extension year, and understand what happens if we take patients who've had disease in the shortest quartile versus the longest quartile. We wanted to understand what clinical outcomes and response look like, and whether that gives us insight into whether it's important to treat early.
HCPLive: Can you share a few details about the trial's overall layout?
Chovatiya: For the actual study, patients were treated with placebo or bimekizumab, and all patients eventually transitioned to bimekizumab. Those who completed year 1, about 48 weeks of BE HEARD I or II, could enroll in the extension and receive open-label treatment with bimekizumab every 2 or 4 weeks, largely based on their HiSCR75/90 achievement. For this analysis, overall disease duration was divided into quartiles: the lowest quartile was about 2.4 years or less of disease, and the highest quartile was about 10.7 years or more. We were looking at patients who'd had disease for a relatively short time, and patients who'd had it for more than a decade.
HCPLive: What were the key efficacy findings when comparing the lowest and highest duration quartiles?
Chovatiya: Across both quartiles, whether lower or longer disease duration, the drug was effective, and that largely mirrors what's been seen in other analyses, as well as a lot of our real-world experience: bimekizumab is one of our most effective options for a disease like HS. But what was very interesting is when you look at outcome measures like 75%, 90%, and 100% improvement in the HiSCR, or the IHS4 score at those same thresholds, the proportion of patients in the lower quartile achieving these responses was greater than in the higher quartile. As you moved to higher thresholds, which is what we aim for in this disease space, getting patients under much better control, that gap became even more pronounced between patients with lower and higher disease duration.
HCPLive: Were there notable differences in how quickly or durably patients responded based on prior HS duration?
Chovatiya: We're looking at numerical differences here, so it's difficult to parse out whether there are going to be clear statistical differences. On the whole, we can be reassured that whether a patient has had HS for a few years or many years, durability was still strong, and overall effectiveness was generally good across the board.
It was just smaller, slightly increasing numerical differences in overall efficacy when we looked at the higher-threshold endpoints. I don't think the data here is the end-all, be-all for proving this window-of-opportunity concept, but it's some of the most compelling data we have to date from a large clinical trial program supporting the idea that earlier treatment may incrementally improve our ability to achieve high-level outcomes.
Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.
References
Saunte DM, Boer J, Stratigos A, et al. Diagnostic delay in hidradenitis suppurativa is a global problem. Br J Dermatol. 2015;173(6):1546-1549.
Chovatiya R, Alavi A, Miyagawa T, et al. Bimekizumab 2-year efficacy by hidradenitis suppurativa duration: BE HEARD EXT results. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.70631.
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.
