INTRODUCTION
Hidradenitis suppurativa (HS) is a chronic inflammatory dermatologic condition presenting with recurrent inflammatory nodules, abscesses, tunnels, and subsequent scarring with predilection for intertriginous areas.1
HS has significant impact on quality of life and is associated with metabolic syndrome and other comorbidities.2 Despite this, there has been a lack of research and treatment development until recent years. The only treatment currently Food and Drug Administration (FDA)-approved for HS is adalimumab, but a growing number of clinical trials are planned and underway. Our aim is to summarize the current clinical trial landscape and potential therapeutic targets.
HS prevalence is estimated to be between 0.1% and 1.2%.1 Women are affected at 2 to 3 times the rate of men,2 and Black patients at 2.5 times the rate of white patients. The highest incidence of HS is in patients aged 18 to 44.2
HS has significant impact on quality of life and is associated with metabolic syndrome and other comorbidities.2 Despite this, there has been a lack of research and treatment development until recent years. The only treatment currently Food and Drug Administration (FDA)-approved for HS is adalimumab, but a growing number of clinical trials are planned and underway. Our aim is to summarize the current clinical trial landscape and potential therapeutic targets.
MATERIALS AND METHODS
Interventional studies in clinicaltrials.gov were identified using search criteria "hidradenitis suppurativa" and included in this review if the study listed HS as a diagnosis and involved a systemic or topical treatment. The review was completed on 10/03/2022. Studies were excluded if they were never initiated or were completed more than 6 months prior to the search being performed.
IL-17 Inhibitors
IL-17 is a proinflammatory cytokine involved in T cell and neutrophil activation. The use of multiple IL-17 inhibitors has been reported for HS. Secukinumab, a human monoclonal antibody binding IL-17A, is currently approved for use in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Twenty subjects participated in a phase 1 open label clinical trial between 2016 and 2019, which demonstrated safety and improvement with 70% of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) in 24 weeks.3 Subsequently, dual phase 3 randomized double blind, placebo-controlled studies (SUNRISE and SUNSHINE) from 2019 to 2022 enrolled 1088 participants receiving 2 different subcutaneous secukinumab dosing regimens or placebo for 16 weeks followed by open-label crossover. SUNRISE reported significant improvement in the primary end point, HiSCR, for secukinumab 300mg q2w (P=0.0149) and q4w (P=0.0022) compared with placebo. The SUNSHINE study demonstrated significant superiority of 300mg q2w compared with placebo (P=0.0070), but not at q4w dosing.4 Application for US FDA approval of secukinumab for the treatment of HS was filed in Fall 2022 and is pending at the time
