Race and Ethnicity Gaps in Global Hidradenitis Suppurativa Clinical Trials.

BACKGROUND: Hidradenitis suppurativa (HS) is an often-debilitating disease characterized by chronic and recurrent painful nodules, abscesses, and sinus tracts affecting the intertriginous areas. Despite evidence in the literature of varying prevalence of HS among different racial and ethnic groups, no studies have evaluated the overall generalizability of clinical trial results considering the increased prevalence of HS among African American populations. Additionally, there is a paucity of data exploring the distribution of race and ethnicity in randomized controlled trials (RCTs) for HS. The goal of this analysis is to explore the distribution of race and ethnicity in recent HS RCTs.

SUMMARY: Using ClinicalTrials.gov and PubMed, race and ethnicity demographics were extracted from phase II and III trials published from 2000 to August 2019. Fifteen trials were included and among these trials 669 (68.0%) participants were Caucasian and 138 (14.0%) were of African descent. Asians, American Indian or Alaskan Natives, and Native Hawaiian or other Pacific Islanders comprised 29 (2.9%), 3 (0.3%), and 1 (0.1%) participant respectively. Only 15 participants were reported as Hispanic as only three trials reported ethnicity data. The remaining 144 (14.6%) participants were recorded as "other/unspecified" (36 self-identified, 108 lacked race reporting). None of the trials included sub-analysis of treatment efficacy based on race or ethnicity.