Bimekizumab Improves Draining Tunnel Outcomes in Patients with Moderate to Severe HS Regardless of Prior Biologic Use: 3-Year Data from BE HEARD EXT

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease characterized by painful lesions, including draining tunnels (DTs). DTs cause irreversible structural damage, negatively impact quality of life, and are indicative of HS disease progression. Delays in initiating biologic treatment beyond the therapeutic “window of opportunity” may lead to increased DT counts. Use of a greater number of prior therapies may also reduce biologic responsiveness. Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody selectively inhibiting IL-17F in addition to IL-17A. We report BKZ impact on DT outcomes, including in prior biologic use subgroups, in patients with moderate to severe HS over 3 years (148 weeks). Procedure: Data were pooled from phase 3 BE HEARD I&II trials (NCT04242446, NCT04242498; BHI&II) and BE HEARD EXT (NCT04901195; BHEXT), for patients with moderate to severe HS. Data are reported for patients randomized to BKZ 320mg from baseline in BHI&II who entered BHEXT and continued BKZ (BKZ Total group). Data are presented for subgroups of biologic-naïve and biologic-experienced patients. Mean (standard deviation [SD]) DT count for all patients and those with ≥1 DT at baseline, proportion of patients with ≥1 DT at baseline with 0, 1–2, 3–5, or >5 DTs are reported at baseline, Year1 (Wk48) and Year3. The proportion of patients with 1–2, 3–5, or >5 DTs at baseline achieving DT=0 are reported at Year1 and Year3. Results: Of 1,014 patients in BHI&II, 868 were randomized to BKZ at baseline. Of those, 556 patients completed Year1 and entered BHEXT. Within the BKZ Total group, 444 patients were biologic-naïve and 112 were biologic-experienced; 425 had ≥1 DT at baseline. In the BKZ Total group, mean (SD) DT count at baseline, Year1, and Year3 was 3.8 (4.3), 1.4 (2.6), and 0.9 (2.0) for all patients, respectively; for biologic-naïve: 3.3 (3.7), 1.2 (2.3), and 0.8 (2.0); for biologic-experienced: 5.6 (5.7), 2.5 (3.3), and 1.3 (2.0). In patients with ≥1 DT at baseline, mean (SD) DT count at baseline, Year1, and Year3 was 4.9 (4.3), 1.8 (2.8), and 1.1 (2.2) for all patients; 4.4 (3.7), 1.5 (2.6), and 0.9 (2.2) for biologic-naïve; and 7.0 (5.5), 3.0 (3.4), and 1.5 (2.1) for biologic-experienced. At Year1, the proportion of patients (%) with 1–2, 3–5, and >5 DTs at baseline, respectively, achieving DT=0 was 64.4, 48.3, and 29.5 for all patients in BKZ Total; for biologic-naïve: 66.7, 50.8, and 36.8; for biologic-experienced: 50.0, 37.0, and 14.3. At Year3, BKZ Total: 79.0, 64.0, and 44.0; biologic-naïve: 78.8, 69.1, and 48.3; biologic-experienced: 80.0, 42.1, and 35.5. Conclusion: Biologic-naïve patients treated with bimekizumab displayed greater achievement of DT outcomes than biologic-experienced patients to Year3, though improvements in DT counts were maintained through 3 years, regardless of prior biologic use. These results may support early initiation of bimekizumab to prevent disease progression.