Bimekizumab shows sustained 2-year efficacy in hidradenitis suppurativa

Long-term treatment with bimekizumab maintained various Hidradenitis Suppurativa Clinical Response (HiSCR) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) scores over 2 years. The corresponding safety monitoring results of the BE HEARD EXT trial were consistent with those observed during year 1.

“Long-term studies give us real information on how new compounds function and what we have to expect for our patients,” Prof. Christos Zouboulis (Dessau Medical Center, Germany) said [1]. He presented 2-year data from the ongoing open-label extension BE HEARD EXT study (NCT04901195), which included 556 participants with hidradenitis suppurativa (HS) from the phase 3 BE HEARD 1 and 2 trials (NCT04242446 and NCT04242498). 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, mean disease duration was 7.4 years, and all participants had Hurley stage II or III. 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. Furthermore, the mean number of draining tunnels changed from 3.8 at baseline to 1.1 after 2 years. Prof. Zouboulis indicated that, until a year ago, only surgical treatment was able to induce a change of disease category.

No new safety signals were observed up to year 2. The most common adverse events were worsening HS (20.5%), COVID-19 (15.3%), and oral candidiasis (10.5%). “We 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 CC, 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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Posted on 6 November 20246 November 2024