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

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.

Posted on 15 May 202317 May 2024