Frequently Asked Questions:
How was disease duration defined in the BE HEARD EXT analysis?
Disease duration was calculated from date of HS diagnosis and divided into quartiles, with the shortest quartile including patients diagnosed less than 2.38 years earlier and the longest quartile including patients diagnosed 10.74 years or more earlier.
What was the key efficacy finding at week 96?
Patients in the shortest-duration quartile reached an IHS4-100 response of 46.1% (53/115), compared with 22.8% (23/101) in the longest-duration quartile, with the gap widening at higher response thresholds.
Does earlier bimekizumab treatment improve outcomes in HS?
The post hoc analysis cannot establish causation, but shorter disease duration was consistently associated with higher rates of stringent response, supporting a possible window-of-opportunity effect.
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.
