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

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. 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. 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. 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. ClinicalTrials.gov identifiers, NCT04242446; NCT04242498. Hidradenitis suppurativa (HS) is a long-term skin condition that causes painful sores, known as lesions, and negatively impacts patients’ quality of life. Bimekizumab is a drug that can treat the symptoms of HS, leading to what is known as ‘clinical response’. This study evaluated whether improvements in clinical response with bimekizumab enhanced quality of life for patients living with HS. We collected data from two clinical trials (BE HEARD I and II). Patients received bimekizumab or a treatment that did not contain any medication (a ‘placebo’). Patients were grouped into categories based on their clinical response level after 16 weeks of treatment. Clinical response was measured by the reduction in the number of lesions each patient had after 16 weeks compared with the start of the trial. Patients completed questionnaires that asked how their HS affected their day-to-day lives; their answers were measured over 48 weeks of treatment. Out of 1,014 patients, 868 received bimekizumab from the start of the trials. Patients with higher clinical response after 16 weeks generally showed greater improvements in their quality of life over 48 weeks of bimekizumab treatment. Patients with the highest clinical response levels showed particularly large improvements in their quality of life. These results suggest that, for patients with HS, achieving a higher level of clinical response with bimekizumab treatment leads to greater improvements in quality of life, highlighting the importance of aiming for high clinical response levels.