HS: Bimekizumab shows sustained 2-year efficacy

Continuing bimekizumab for 2 years led to maintenance of various Hidradenitis Suppurativa Clinical Response (HiSCR) scores and International Hidradenitis Suppurativa Severity Score System (IHS4) scores. The safety results of the ongoing BE HEARD EXT trial were in line with those observed up to year 1.

Prof. Christos Zouboulis (Dessau Medical Centre, Germany) presented 2-year data from the ongoing BE HEARD EXT open-label extension study (NCT04901195), which included 556 participants with hidradenitis suppurative (HS) from the phase 3 BE HEARD 1 and 2 trials (NCT04242446 and NCT04242498) [1]. In BE HEARD EXT, participants achieving HiSCR≥90 at 1 year continued bimekizumab 320 mg every 4 weeks; those with a HiSCR<90 continued on a dose of 320 mg every 2 weeks.

The baseline characteristics included a mean age of 36.3 years, 53.8% were women, a mean disease duration of 7.4 years, and all participants had Hurley stage 2 or 3. Prof. Zouboulis highlighted a mean count of 16.9 abscesses and inflammatory nodules and 3.8 draining tunnels.

The results for various HiSCR rates over time showed a sustained treatment effect over 2 years with 85.4% reaching HiSCR50, 77.1% HiSCR75, 57.6% HiSCR90, and 44.2% HiSCR100. In addition, the IHS4 score changes from baseline were maintained: -70.3 at year 1 and -79.8% at year 2, with a baseline mean IHS4 of 35.6 and a 96-week mean of 7.2. Further, the mean number of draining tunnels changed from 3.8 at baseline to 1.1 after 2 years. Prof. Zouboulis indicated that until 1 year ago only surgical treatment had been able to induce a change of disease category.

No new safety signals were observed up to year 2. The most common adverse events were HS (20.5%), COVID-19 (15.3%), and oral candidiasis (10.5%). “We can now have drugs that can change disease category from severe to moderate and from moderate to mild, and this is completely new,” Prof. Zouboulis emphasised in his conclusion.

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   1. Zouboulis C, et al. Bimekizumab efficacy and safety through 2 years in patients with hidradenitis suppurativa: Results from the phase 3 BE HEARD I&II trials and open-label extension BE HEARD EXT. D3T01.3A, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.

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Medical writing support was provided by Karin Drooff MPH



Posted on 2 October 20242 October 2024