Bimekizumab demonstrated a favorable safety profile and high levels of efficacy with up to 2 years of treatment in patients with moderate to severe hidradenitis suppurativa: Pooled results from two phase 3 randomized, controlled trials and their open-label extension

Abstract

Background: Hidradenitis suppurativa is a chronic inflammatory disease, requiring treatment with durable efficacy and tolerability.

Objective: To report the safety and efficacy of bimekizumab up to 2 years.

Methods: Data from the BE HEARD I&II phase 3 trials and their open-label extension, BE HEARD Extension, were pooled to assess the safety and efficacy of bimekizumab in patients with moderate to severe hidradenitis suppurativa up to 2 years. For safety, exposure-adjusted incidence rates of treatment-emergent adverse events per 100 patient-years (TEAEs/100 PY) were evaluated. For efficacy, lesional-/skin pain-/health-related quality of life (HRQoL) outcomes were assessed.

Results: Five hundred fifty-six patients entered the open-label extension; 446 received bimekizumab to Year 2. TEAEs did not increase with longer bimekizumab exposure (Year 1: 261.6/100 PY; Year 2: 235.7/100 PY). In Year 2, the most common TEAEs were hidradenitis (26.6/100 PY), coronavirus infection (23.1/100 PY), and oral candidiasis (12.5/100 PY). Most patients achieved HiSCR50/75/90/100 at Year 2 (85.4%/77.1%/57.6%/44.2%). Improvements in skin pain and HRQoL achieved at Year 1 were sustained at Year 2.

Limitations: Patient inclusion criteria limit real-world generalizability.

Conclusions: Bimekizumab was well-tolerated up to 2 years; no new safety signals were identified with longer exposure. Bimekizumab provided deep, durable improvements in clinical and HRQoL outcomes.

Keywords: BE HEARD; IL-17 inhibitors; bimekizumab; cytokines; hidradenitis suppurativa; inflammatory skin disease; open-label extension; randomized controlled trial.