Bimekizumab Elicits Clinically Meaningful Responses in Moderate to Severe Hidradenitis Suppurativa

In newly published findings from the pivotal phase 3 BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) trials, bimekizumab was well tolerated and elicited clinically meaningful responses in patients with moderate to severe hidradenitis suppurativa (HS). The data were published in The Lancet.¹

HS is a chronic, systemic inflammatory skin condition that can lead to disability and comorbidities that substantially impact patients’ lives, but there are few therapeutic options for this patient population. The BE HEARD I and BE HEARD II trials were identically designed to assess bimekizumab, a first-in-class monoclonal immunoglobulin G1 antibody that selectively inhibits IL-17F and IL-17A, in adult patients with moderate to severe HS.

Both trials were randomized, double-blind, placebo-controlled, multicenter studies, and both were 48 weeks long. Recruitment for BE HEARD I took place from February 19, 2020, to October 27, 2021, with 505 patients enrolled. BE HEARD II participants were recruited from March 2, 2020, to July 28, 2021, with 509 patients enrolled.

Hidradenitis suppurativa | Image credit: Yurii Kibalnik - stock.adobe.com

The main outcome was a clinical response of at least 50%, defined as a 50% reduction in total abscesses and inflammatory nodules from baseline with no increase in abscess or draining tunnel count (HiSCR50) at 16 weeks. All randomly assigned patients (the intention-to-treat population) were included in efficacy analyses, and all patients who received at least 1 dose of study treatment in the safety set and of bimekizumab in the active medication set were included in the safety analyses.

In BE HEARD I, 289 patients were randomly assigned to receive bimekizumab every 2 weeks, 144 received bimekizumab every 4 weeks, and 72 received placebo. In BE HEARD II, 291 patients received bimekizumab every 2 weeks, 144 received bimekizumab every 4 weeks, and 74 received placebo.

The bimekizumab group experienced higher response rates vs placebo in both trials. In BE HEARD I, 138 (48%) of 289 patients in the bimekizumab group showed HiSCR50 vs 21 (29%) of 72 patients in the placebo group (OR, 2.23; 97.5% CI, 1.16-4.31; P = .006). In BE HEARD II, 151 (52%) of 291 patients in the bimekizumab group experienced HiSCR50 vs 24 (32%) of 74 patients in the placebo group (OR, 2.29; 1.22-4.29; P = .0032). HiSCR50 was also met in the BE HEARD II cohort who received bimekizumab every 4 weeks, with 77 (54%) of 144 patients experiencing HiSCR50 vs 24 (32%) of 74 patients who received a placebo (OR, 2.42; 1.22-4.80; P = .0038).

Responses to treatment were seen as early as 4 weeks into treatment and were either maintained or increased through week 48 of the study.

In both trials, a key secondary outcome was HiSCR75 at week 16, and this outcome was met in patients receiving bimekizumab every 2 weeks. Ninety-seven (33%) of 289 patients in BE HEARD I experienced HiSCR75 vs 13 (18%) of 72 patients who received a placebo, and 104 (36%) of 291 patients who received bimekizumab every 2 weeks in BE HEARD II experienced HiSCR75 vs 12 (16%) of 74 patients treated with placebo. HiSCR75 occurred by week 4 in the BE HEARD I and BE HEARD II groups that received bimekizumab every 2 weeks, and the proportions of patients who experienced HiSCR75 stayed consistent or increased through week 48.

In both trials, the most common treatment-related adverse event through week 48 was hidradenitis. Coronavirus infection and diarrhea were also common in BE HEARD I, as were oral candidiasis and headache in BE HEARD II. Overall, no new safety signals were seen.

“The phase 3 studies with bimekizumab represent a significant milestone for the hidradenitis suppurativa community, and they include HiSCR75, a high threshold end point, as a key ranked secondary outcome. In these studies, bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease,” lead investigator Alexa B. Kimball, MD, MPH, CEO and president of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and a professor of dermatology at Harvard Medical School, said in a statement.² “These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future.”

In April 2024, the European Commission granted marketing authorization for bimekizumab for the treatment of active moderate to severe HS in adults who do not experience adequate responses with conventional therapies, and the FDA accepted a supplemental biologics license application for bimekizumab-bkzx for the treatment of adults with moderate to severe HS.

References

1. Kimball AB, Jemec GB, 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. Lancet. Published online May 22, 2024. Accessed May 23, 2024. doi:10.1016/S0140-6736(24)00101-6

2. UCB announces publication in The Lancet of phase 3 bimekizumab trials in moderate to severe hidradenitis suppurativa. News release. UCB. May 23, 2024. Accessed May 23, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-publication-in-The-Lancet-of-phase-3-bimekizumabV-trials-in-moderate-to-severe-hidradenitis-suppurativa