Abstract
INTRODUCTION: Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation). METHODS: Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed. RESULTS: A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48. CONCLUSIONS: Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain. TRIAL REGISTRATION: NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.