P080 Bimekizumab efficacy and impact on pain in moderate-to-severe hidradenitis suppurativa: results from BE HEARD I and II
Authors: Ingram John R , Orenstein Lauren A V , Shi Vivian Y , Lev-Tov Hadar , Prens Errol , Lambert Jérémy , Rolleri Robert , Kirby Brian , Rashidghamat Ellie 
Published: June 2024

Abstract
Hidradenitis suppurativa (HS) is a debilitating skin disease, with pain being the most impactful symptom. Treatment options are limited; bimekizumab (BKZ), a humanized monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A, was studied in the phase III BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) studies. Efficacy and pain data were used to assess whether BKZ treatment improves outcomes over 48 weeks. Pooled data from BE HEARD I and II included both initial (weeks 0–16) and maintenance (weeks 16–48) treatment periods. Patients with moderate-to-severe HS were randomized 2 : 2 : 2 : 1 (initial/maintenance) to BKZ 320 mg every 2 weeks (Q2W)/Q2W, BKZ Q2W/every 4 weeks (Q4W), BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. Proportions of patients with ≥ 50/75/90% HS Clinical Response (HiSCR 50/75/90) at week 16 and week 48 were reported using modified nonresponder imputation (mNRI). In this model, patients who discontinued due to lack of efficacy or adverse events, or who received systemic antibiotics, were considered nonresponders; multiple imputation was used for all other missing data. HS Symptom Questionnaire (HSSQ) assessed patients’ perception of core symptoms (including Skin Pain) over the past 7 days (item score 0–10). Changes from baseline at week 16 and week 48 were reported using multiple imputation. Clinically meaningful HSSQ Skin Pain responder rates were defined as ≥ 30% improvement and ≥ 1-point reduction (mNRI) among patients with a baseline score of ≥ 3. In total, 1014 patients were randomized: BKZ Q2W/Q2W (n = 288), BKZ Q2W/Q4W (n = 292), BKZ Q4W/Q4W (n = 288) and PBO/BKZ Q2W (n = 146). Baseline demographics were similar. BKZ-treated patients showed higher response rates in the primary endpoint, HiSCR50, at week 16 compared with PBO (Q2W/Q2W 58.0%, Q2W/Q4W 55.9%, Q4W/Q4W 56.1%, PBO/BKZ Q2W 33.4%). At Wk48, HiSCR50 was sustained from week 16 for patients receiving BKZ from baseline, while PBO/BKZ switchers demonstrated comparable improvements (Q2W/Q2W 61.1%, Q2W/Q4W 62.6%, Q4W/Q4W 58.5%, PBO/BKZ Q2W 57.9%). Similar trends were observed in more stringent endpoints, HiSCR75/90, through week 48. BKZ-treated patients demonstrated numerically greater HSSQ Skin Pain reductions (mean change from baseline) compared with PBO at week 16 (Q2W/Q2W −2.5, Q2W/Q4W −2.0, Q4W/Q4W −1.7, PBO/BKZ Q2W −0.8). Improvements were similar between groups at week 48 (Q2W/Q2W −2.9, Q2W/Q4W −2.5, Q4W/Q4W −2.8, PBO/BKZ Q2W −2.5). Numerically greater HSSQ Skin Pain responder rates were seen with BKZ vs. PBO at week 16 (Q2W/Q2W 60.8%, Q2W/Q4W 52.3%, Q4W/Q4W 49.1%, PBO/BKZ Q2W 30.7%). At week 48, similar responder rates were observed between PBO/BKZ switchers and the continually BKZ-treated groups (Q2W/Q2W 61.0%, Q2W/Q4W 51.7%, Q4W/Q4W 59.0%, PBO/BKZ Q2W 51.8%). A higher proportion of BKZ-treated vs. PBO-treated patients reached clinically meaningful HiSCR50/75/90 and HSSQ Skin Pain improvements at week 16. HiSCR and HSSQ Skin Pain responses were maintained or increased to week 48. This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical.