Bimekizumab Efficacy and Safety Through 3 Years in Patients with Hidradenitis Suppurativa: Results from the Phase 3 BE HEARD I&II Trials and Their Open-Label Extension BE HEARD EXT

Introduction Hidradenitis suppurativa (HS) is a chronic, relapsing skin disease characterized by painful inflammatory nodules, abscesses and draining tunnels that causes disability and reduces patients’ health-related quality of life (HRQoL).1–3 Long-term disease control is essential to prevent irreversible damage and disease progression.4 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated clinically meaningful improvements in patients with HS over 2 years of treatment.5–7 Here, the efficacy and safety of BKZ in patients with moderate to severe HS are reported up to 3 years (efficacy: 148 weeks; safety: 144 weeks) of treatment. Procedure Data were pooled from BE HEARD I&II (BHIⅈ NCT04242446/NCT04242498) and BE HEARD EXTENSION (BHEXT; NCT04901195). We report HS Clinical Response (HiSCR)50/75/90/100 rates, absolute change from baseline (CfB) in draining tunnel (DT) count, and Dermatology Life Quality Index (DLQI) 0/1 achievement at Week 48 and Week 148, plus a safety overview up to 3 years. For efficacy outcomes, we report data for patients who were randomized to BKZ from baseline in BHI&II who entered BHEXT (BKZ Total group; data reported as observed case [OC]). For safety outcomes, we report data for patients who received ≥1 dose of BKZ across BHI&II/BHEXT. Results Of 1,014 total patients, 556 patients randomized to BKZ at baseline in BHI&II completed Week 48 and entered BHEXT; of these, 367 completed Week 148. At Week 48, HiSCR50/75/90/100 responses were 79.9%/64.0%/42.3%/30.2%; responses were maintained to Week 148 at 90.2%/81.2%/64.3%/50.1%. At Week 48, from a baseline mean (standard deviation [SD]) of 3.8 (4.3), the mean absolute CfB (SD) in DTs was −2.4 (3.4); responses were sustained to Week 148 at −3.1 (3.9). The proportion of patients who reported DLQI 0/1 was 27.4% (151/551) at Week 48 and 38.1% (137/360) at Week 148. Up to 3 years, the exposure-adjusted incidence rate (EAIR) for any treatment-emergent adverse event (TEAE) was 226.8/100 participant-years (PY). The EAIRs/100 PY for serious TEAEs and TEAEs leading to discontinuation were 7.2 and 6.0, respectively. The most common TEAEs were hidradenitis (20.7/100 PY), coronavirus infection (15.3/100 PY), and oral candidiasis 10.4/100 PY). Serious infection TEAEs occurred in 37 patients (2.0/100 PY). Safety data were consistent with previous observations and with 2-year data from BHI&II/BHEXT.7 Conclusion Efficacy and HRQoL outcomes observed in the bimekizumab HS phase 3 trials were maintained through 3 years of treatment. Bimekizumab was well-tolerated and no new safety signals were identified up to 3 years of treatment. These data highlight the depth and durability of response to bimekizumab treatment in patients with moderate to severe HS.