Association Between Bimekizumab’s Clinical Response and Patient-Reported Benefits on Health-Related Quality of Life: Results from BE HEARD I and II

Introduction: Hidradenitis suppurativa (HS) is a chronic skin disease that greatly affects patients’ health-related quality of life (HRQoL). Bimekizumab, a humanised monoclonal antibody that inhibits interleukin (IL)-17A and IL‑17F, has demonstrated efficacy in HS. This study aimed to assess the association between clinical response and patient-reported benefits on HRQoL, using pooled 48-week data from BE HEARD I&II, in moderate to severe HS. Methods: Patients received (initial/maintenance; treatment switch at Week 16) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, Q2W/every 4 weeks (Q4W), Q4W/Q4W or placebo/Q2W. Data are reported for patients randomised to bimekizumab from baseline (bimekizumab Total group) and Q2W/Q4W (Supplement). Patients were grouped into Week 16 HS Clinical Response (HiSCR) bands (HiSCR<50/50–<75/75–<90/90–100). Proportions of patients meeting pre-defined thresholds in HRQoL outcomes are reported at Weeks 16/48: meaningful improvements in HS QoL questionnaire (HiSQOL) total response and domain scores, no/mild impact of HS on HRQoL and Dermatology Life Quality Index (DLQI) scores 0/1 and 0–5. Results: At Weeks 16/48, greater proportions of patients achieved HiSQOL total score responses with higher Week 16 HiSCR bands (HiSCR<50: 28.2%/35.9%; HiSCR50–< 75: 34.6%/37.2%; HiSCR75–< 90: 36.1%/47.5%; HiSCR90–100: 57.4%/66.2%). Similar patterns were observed across HiSQOL domains and in the proportions of patients who reported no/mild impact on HRQoL (HiSQOL total score ≤14). At Weeks 16/48, greater proportions of patients who achieved Week 16 HiSCR75–<90/HiSCR90–100 reported DLQI 0/1 (HiSCR75–< 90: 19.1%/27.3%; HiSCR90–100: 34.8%/43.3%) compared with patients who achieved HiSCR<50/HiSCR50–<75 (HiSCR<50: 16.1%/19.6%; HiSCR50–<75: 12.9%/17.2%). Similar trends were observed in the proportions of patients reporting DLQI scores of 0–5. Across HiSCR bands, HiSQOL/DLQI outcomes were maintained or improved from Weeks 16–48. Conclusions: For patients with HS, achievement of greater lesion reduction with bimekizumab (at Week 16) translated into greater clinically meaningful improvements in HRQoL over the longer term. Trial registration: ClinicalTrials.gov identifiers, NCT04242446; NCT04242498.