Bimekizumab clinical efficacy responses translate into improvements in patient outcomes to Week 48 in patients with moderate to severe hidradenitis suppurativa: Results from BE HEARD I&II

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease whereby debilitating symptoms reduce patients’ health-related quality of life (HRQoL).^1,2 Previously, achievement of higher HS Clinical Response (HiSCR) thresholds with bimekizumab (BKZ; a humanized IgG1 monoclonal antibody that selectively inhibits interleukin [IL]‑17F and IL-17A) translated into better patient outcomes.^3,4 We report how achieving increasingly higher HiSCR thresholds associates with improvements in HRQoL in patients with moderate to severe HS, using data from the phase 3 BE HEARD I&II trials. We also assess how achieving increasingly higher HiSCR thresholds is associated with improvements in patient-reported skin pain with BKZ treatment in patients with moderate to severe HS.

Procedure: Data were pooled from phase 3 BE HEARD I&II studies.⁵ Patients were grouped by achievement of mutually exclusive HiSCR thresholds at Week16/48: <50% improvement from baseline (<HiSCR50); 50–<75% improvement (HiSCR50–<75); 75–<90% improvement (HiSCR75–<90); 90–100% improvement (HiSCR90–100). Associations between the level of clinical efficacy and achievement of clinically meaningful within-patient improvements in HS QoL questionnaire (HiSQOL) response (≥21oint reduction) and HS symptom questionnaire (HSSQ) skin pain response (30% and ≥1oint reduction) were assessed at Week16/48. Data reported as observed case for patients randomized to BKZ (BKZ Total).

Results: Overall, 1,014 patients were randomized. For BKZ Total (N=868), 90.0%/70.9% completed Week16/48. At Week16, increasing HiSQOL response rates were observed with increasing HiSCR threshold achievement: <HiSCR50: 25.0%; HiSCR50–<75: 27.6%; HiSCR75–<90: 39.2%; HiSCR90–100: 57.8%. At Week16, increasing HSSQ skin pain response rates were observed with increasing HiSCR thresholds: <HiSCR50: 42.5%; HiSCR50–<75: 52.9%; HiSCR75–<90: 63.9%; HiSCR90–100: 80.4%. Similar trends were observed at Week48: HiSQOL: <HiSCR50: 24.7%; HiSCR50–<75: 43.9%; HiSCR75–<90: 45.3%; HiSCR90–100: 57.6%; HSSQ skin pain: <HiSCR50: 50.9%; HiSCR50–<75: 60.9%; HiSCR75–<90: 77.3%; HiSCR90–100: 82.7%.

Conclusion: Achieving higher efficacy thresholds with BKZ treatment translated into clinically meaningful improvements in HRQoL and skin pain. Higher treatment goals should be targeted to provide better patient reported outcomes.