Home > Dermatology > AAD 2023 > Hidradenitis Suppurativa: What You Need to Know > Bimekizumab could be the new up-and-comer for HS treatment

Bimekizumab could be the new up-and-comer for HS treatment

Presented by
Prof. Alexa Kimball, Harvard Medical School, MA, USA
Medical Writer
Susanne Kammerer
AAD 2023
Therapy of hidradenitis suppurativa (HS) with bimekizumab entailed meaningful ameliorations for patients in the BE HEARD I and II trials. The treatment goal of a 50% hidradenitis suppurativa clinical response (HiSCR50) was attained by about half of the participants.

As IL-17A and IL-17F play an important role in various immune-mediated inflammatory diseases including HS, the principle of dual inhibition of both cytokines appeared promising to increase response rates in HS [1,2]. The pivotal, phase 3 BE HEARD I trial (NCT04242446) and BE HEARD II trial (NCT04242498) included a total of 1,014 patients with moderate-to-severe HS with at least 5 lesions and ≤20 draining tunnels [3]. Concomitant antibiotics were allowed and patients receiving antibiotics were classified as non-responders. The study treatment varied among the 4 study arms of the 2 studies, with an initial period up to week 16, and subsequent maintenance part up to week 48.

Group 1 received 320 mg of bimekizumab every 2 weeks over both study periods (Q2W/Q2W). Group 2 started with bimekizumab at 320 mg bi-weekly and switched to every 4 weeks after week 16 (Q2W/Q4W). Group 3 was kept on an every 4 weeks dose of bimekizumab 320 mg (Q4W/Q4W) from start to week 48. Group 4 began with a placebo until week 16 and continued on 320 mg of bimekizumab every second week (PCO/Q2W). The primary endpoint was the HiSCR50 response at week 16.

Baseline measures in BE HEARD I and BE HEARD II included mean age of 36.7 and 36.6 years, 63.0% and 50.7% were women, mean duration of HS of 9 and 7 years, Hurley stage 3 in 49.7% and 38.9%, and previous biologic medication in 25% and 13.2% of participants.

At the primary endpoint, in BE HEARD I a HiSCR50 was reached in 45.3% of participants in Q4W (P=0.03 vs placebo), 47.8% in Q2W (P=0.006 vs placebo), and 28.7% in the placebo group (see Table). The corresponding results from BE HEARD II were 53.8% (P<0.01), 52.0% (P<0.01), and 32.2%, respectively. As can be expected, the rates for achieving HiSCR75 at week 16 were overall lower. In BE HEARD II, the rates were 33.7% and 35.7% in the 2 bimekizumab arms versus 15.6% in the placebo arm (P<0.01 for both comparisons). During the maintenance period, the responses were overall sustained with a HiSCR75 in 59.8% (PCO/Q2W), 53.9% (Q4W/Q4W), 48.8% (Q2W/Q4W), and 47.3% (Q2W/Q2W) in BE HEARD 2 at week 48. The participants in the placebo group also demonstrated clinical response within the range of the other treatment arms.

Table: Results from BE HEARD I and BE HEARD II

“In particular, the HiSCR results we achieved in the BE HEARD II trial are a huge milestone for our patients,” Prof. Alexa Kimball (Harvard Medical School, MA, USA) underlined in her conclusion.

  1. Glatt S, et al. JAMA Dermatol. 2021;157:1279–88.
  2. Fletcher JM, et al. Clin & Exp Immunol 2020;201:121–34.
  3. Kimball A. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicentre studies. S042, AAD 2023 Annual Meeting, 17–21 March, New Orleans, USA.

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