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Phase 3 trials in moderate to severe hidradenitis suppurativa

Results from the Phase 3 BE HEARD I and BE HEARD II trials evaluating the efficacy and safety of bimekizumab▼, an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe hidradenitis suppurativa (HS)1 have been published in The Lancet.

The article represents the primary publication of bimekizumab data from the two pivotal Phase 3 HS studies. HS is one of the most burdensome, chronic, systemic, inflammatory skin diseases that can have a profound impact on patients’ health-related quality of life.2,3,4

In April 2024, UCB announced that the European Commission granted marketing authorisation for bimekizumab for the treatment of active moderate to severe HS in adults, with an inadequate response to conventional systemic HS therapy.

UCB also announced that the U.S. Food and Drug Administration accepted for review the supplemental biologics license application for bimekizumab-bkzx, for the treatment of adults with moderate to severe HS. Other regulatory submissions for bimekizumab in the treatment of moderate to severe hidradenitis suppurativa are underway around the world.

Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB said: “Publication of results from the BE HEARD I and II trials in The Lancet reflects the significance of these data to the dermatology community. People living with HS face high unmet medical needs. The positive results from these trials support global regulatory submissions for bimekizumab in this chronic inflammatory skin disease.”


1 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 The Lancet. Published Online May 22, 2024. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00101-6/fulltext

2 Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158–64.

3 Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.

4 Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12(1):785–90.

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Joanna Harvey
Joanna Harvey
Marketing and Communication Executive | Uniphar Commercial


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