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Ethnoracial representation in hidradenitis suppurativa clinical trials

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Abstract

Background

Hidradenitis suppurativa (HS) is an inflammatory skin disorder characterized by recurring painful and suppurating lesions, with the disease disproportionately affecting black populations in the United States. Ethnoracial representation in clinical trials is vital to ensuring results are generalizable. The purpose of this study is to examine whether ethnic or racial disparities exist in HS clinical trials.

Methods

The US National Library of Medicine clinical trials database (clinicaltrials.gov) was queried to identify HS clinical trials. Trials that did not present ethnic or racial data on either the website or publication were not considered.

Results

A total of 57 HS trials were identified. Of these, 23 trials, containing 2530 patients, included racial or ethnic data (Table 1). White patients made up 76.1% (1435/1886) of the study population, followed by Blacks or African Americans (13.7% (238/1732)), Hispanics or Latinos (7.2% (20/279), Asians (2.6% (26/1016)), American Indians or Alaska Natives (1.3% (14/1051)), and Native Hawaiians or Other Pacific Islanders (0.4% (4/926)).

Discussion

Our results establish a significant lack of minority ethnoracial representation in HS clinical trials. Since HS prevalence is highest among Blacks or African Americans, it is imperative that future clinical trials are conducted with a larger proportion of this population. Furthermore, clinical trials that did not report racial or ethnic information were conducted in countries with predominantly White populations, which likely skewed the results of this study and caused underreporting of these patients.

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Data availability statement

The data that support the findings of this study are available at clinicaltrials.gov.

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Funding

None. This research was supported by AbbVie, Castle Biosciences, CorEvitas, Dermavant, Galderma, Mindera, Pfizer, Novartis, Regeneron Pharmaceuticals, Arcutis, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen Biotech, Leo, Lilly, Sun, UCB and Amgen.

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Authors and Affiliations

  1. Department of Dermatology, University of California, San Francisco, 515 Spruce Street, San Francisco, CA, 94118, USA

    Kareem G. Elhage, Mitchell S. Davis, Marwa Hakimi, Riley K. Spencer, Joy Q. Jin, Samuel Yeroushalmi, Mimi Chung, Erin Bartholomew, Tina Bhutani & Wilson Liao

Authors
  1. Kareem G. Elhage
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  2. Mitchell S. Davis
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  3. Marwa Hakimi
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  4. Riley K. Spencer
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  5. Joy Q. Jin
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  6. Samuel Yeroushalmi
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  7. Mimi Chung
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  8. Erin Bartholomew
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  9. Tina Bhutani
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  10. Wilson Liao
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Contributions

KE, MD, and MH drafted and wrote the main manuscript text. RS, JJ, SY, MC, and EB were involved in critical revision of the manuscript. TB and WL were involved in conceptualization and planning of the manuscript text as well as critical revision of the manuscript.

Corresponding author

Correspondence to Kareem G. Elhage.

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Conflict of interest

Tina Bhutani is a principal investigator for trials sponsored by Abbvie, Castle, CorEvitas, Dermavant, Galderma, Mindera, and Pfizer. She has received research grant funding from Novartis and Regeneron. She has been an advisor for Abbvie, Arcutis, Boehringer-Ingelheim, Bristol Myers Squibb, Janssen, Leo, Lilly, Novartis, Pfizer, Sun, and UCB. Wilson Liao has received research grant funding from Abbvie, Amgen, Janssen, Leo, Novartis, Pfizer, Regeneron, and TRex Bio. The remaining authors have nothing to disclose.

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Elhage, K.G., Davis, M.S., Hakimi, M. et al. Ethnoracial representation in hidradenitis suppurativa clinical trials. Arch Dermatol Res 315, 1793–1796 (2023). https://doi.org/10.1007/s00403-022-02510-4

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  • DOI: https://doi.org/10.1007/s00403-022-02510-4

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