ArticlePain and therapy2025
Bimekizumab Pain Outcomes in Patients with Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II Phase 3 Randomized Clinical Trials.
Article in Pain and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
Who cites it
1 citing paper in PubMed.
- Hidradenitis Suppurativa and IL-17 Inhibitors: A Focus on Trials and Real-Life Data.Medicina (Kaunas, Lithuania) · 2026Review
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPain 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).
methodsPatients 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.
resultsA 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.
conclusionsTreatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.
trial registrationNCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.
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