Bimekizumab Impact on Flare in Hidradenitis Suppurativa Over 2 Years: Data from BE HEARD EXT

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Haley B. Naik
Steven Daveluy
Errol Prens
Ziad Reguiai
Pablo Fernandez-Peñas
Sayaka Yamaguchi
Bartosz Lukowski
Christina Crater
Leah Davis
Antonio Martorell-Calatayud

Keywords

hidradenitis suppurativa, flare, bimekizumab

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterised by recurrent nodules, abscesses and draining tunnels, with patients often experiencing periodic worsening of symptoms, known as flares.1 Achieving disease control is important to reduce flare frequency.1 Bimekizumab (BKZ) is a humanised monoclonal IgG1 antibody which selectively inhibits interleukin (IL)-17A and F.2 We report the proportion of patients who experienced a flare at a given visit and the cumulative proportion of patients who remained flare-free up to Weeks (Wks)48 and 96, from the BE HEARD I&II trials and their OLE, BE HEARD EXT, in patients with moderate-to-severe HS.3,4


Procedure: Data pooled from the BE HEARD I&II studies and BE HEARD EXT. Wk48 completers could enroll in BE HEARD EXT and receive open-label BKZ 320 mg Q2W/Q4W based on ≥90% HS Clinical Response (averaged from BE HEARD I&II Wks36, 40 and 44).


Patients randomised to receive BKZ from baseline in BE HEARD I&II and who entered BE HEARD EXT were included (BKZ Total). Flare defined as ≥25% increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of ≥2 relative to baseline. Proportion of patients who experienced a flare at the given visit (single point) and cumulative proportion (any visit up to and including the given timepoint) who remained flare-free up to Wks48 and 96 are reported as OC. 


Results: 556 patients randomised to BKZ in BE HEARD I&II completed Wk48 and entered BE HEARD EXT; 446 of these completed a lesion count assessment at Wk96. At Wk48, (12/556 [2.2%]) patients in BKZ Total experienced a flare. This low rate was maintained at Wk96 (5/446 [1.1%]). Most (466/556 [83.8%]) patients in BKZ Total remained flare-free to Wk48; this was maintained through Wk96 (372/446 [83.4%]).


Conclusion: The majority of patients with moderate-to-severe HS treated with bimekizumab did not experience a flare at any given study visit and remained flare-free through 2 years.


Funding: UCB. Medical writing provided by Costello Medical. Previously submitted to EHSF 2025.

References

1. Masson R et al. Skin Appendage Disord 2024;10:224–28

2. Adams R et al. Front Immunol 2020;11:1894

3. Kimball AB et al. Lancet 2024;403:2504–19 (NCT04242446, NCT04242498)

4. BE HEARD EXT: www.clinicaltrials.gov/study/NCT04901195

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