Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic, immune-mediated skin condition characterized by inflammatory lesions that can cause pain, impaired physical activity, and reduced quality of life. This study evaluated the efficacy and safety of risankizumab, a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit, for the treatment of HS. Methods: This phase II multicenter, randomized, placebo-controlled, double-blind study investigated the efficacy and safety of risankizumab in patients with moderate-to-severe HS. Patients were randomized 1:1:1 to receive subcutaneous risankizumab 180 mg; risankizumab

Emerging Treatments and the Clinical Trial Landscape for Hidradenitis Suppurativa Part I: Topical and Systemic Medical Therapies

“…Risankizumab is a humanized monoclonal antibody that inhibits IL-23p19. A phase 2 trial in 243 participants evaluated two dosing regimens of risankizumab compared with placebo [ 111 ]. The study was terminated early, as the primary endpoint was not met: 46.8% of patients in the risankizumab 180 mg group, 43.4% of the risankizumab 360 mg group, and 41.5% of the placebo group achieved HiSCR at week 16.…”

Adalimumab-Induced Paradoxical Psoriasis Treated with Biologics Targeting the IL-17/IL-23 Axis in Patients with Hidradenitis Suppurativa

“…Moreover, the results from two phase III trials have demonstrated sustained efficacy and safety of secukinumab on HS for up to 52 weeks of treatment, when given every 2 weeks [16]. On the contrary, phase II studies did not provide strong evidence to support the efficacy of IL-23 inhibitors on HS, putting into question the central role of the IL-23/T-helper 17 axis in HS pathophysiology [17, 18].…”

Hidradenitis Suppurativa: An Understanding of Genetic Factors and Treatment

“…HiSCR was achieved by 46.8%, 43.4%, and 41.5% at week 16, respectively, indicating that risankizumab does not appear to be an effective treatment for moderate-to-severe HS [98].…”

“…A phase II trial allocated patients randomly to receive risankizumab 180 mg, risankizumab 360 mg, or placebo subcutaneously. HiSCR was achieved by 46.8%, 43.4%, and 41.5% at week 16, respectively, indicating that risankizumab does not appear to be an effective treatment for moderate-to-severe HS [98].…”