Under-representation of racial and ethnic minorities in nail psoriasis randomized clinical trials: A call to action

Ricardo, José; Lipner, Shari R.

doi:10.1016/j.jaad.2022.01.043

Cited by 6 publications

(2 citation statements)

References 5 publications

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“… 12 , 21 , 22 In HS, a disease predominantly affecting females of childbearing age, these requirements may pose a significant barrier to participation and prohibitively exclude a crucial demographic. 22 , 23 While awareness of the problem is a necessary first step, additional considerations are needed to improve clinical trial access for female patients. The major limitation of clinical trial enrollment seems to be pregnancy concerns, both by the patients and by strict requirements for enrollment.…”

Section: Discussionmentioning

confidence: 99%

“…Despite enrollment conditions designed to prevent pregnancy, there continue to be many pregnancies in HS trials, calling into question whether these requirements achieve their aim. 22 , 23 It may be beneficial to consider the likelihood of pregnancy and potential impact of the drug on the fetus. Allowing more leniency for female patients, such as exempting patients who are infertile or postmenopausal or those whose exclusive sexual activity is with same-sex partners, seems like a reasonable step to increase clinical trial availability for more female patients.…”

Section: Discussionmentioning

confidence: 99%

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Evaluating minority representation across health care settings in hidradenitis suppurativa and psoriasis

Greif,

Gibson,

Kimball

et al. 2024

International Journal of Women’s Dermatology

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Background: Females and minorities have been underrepresented in clinical research despite legislative efforts, including in hidradenitis suppurativa (HS) and psoriasis (PsO) clinical trials. Objective: To identify differences in demographic breakdowns of HS and PsO patients between health care settings to uncover any causative health disparities. Methods: This study reports racial, ethnic, and sex of HS and PsO patient populations across the emergency department (ED), inpatient, clinical trial, and registry settings. In addition, 95% confidence intervals are used as proxies of statistical significance to compare demographics between settings. Results: Female, Hispanic, and Black patients were underrepresented in HS clinical trials compared to their population prevalence (female: 63.7% vs 73.5%; Hispanic: 3.8% vs 12.0%; Black: 9.1% vs 20.3%). Female and Black patients were underrepresented in PsO trials compared to their population prevalence (female: 33.0% vs 54.8%; Black: 2.2% vs 5.7%). Black patients were overrepresented in the inpatient and ED settings in HS (inpatient vs ED vs population prevalence: 49.9% vs 49.9% vs 20.3%) and in the inpatient setting in PsO (inpatient vs population prevalence: 19.8% vs 5.7%). Limitations: The main limitation is the reliability and generalizability of the published studies used to compare demographics across settings. Conclusion: Underrepresentation of females and minorities in HS and PsO clinical trials is consistent with published literature. Overrepresentation of Black patients in acute care settings is likely multifactorial.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluating minority representation across health care settings in hidradenitis suppurativa and psoriasis

Greif,

Gibson,

Kimball

et al. 2024

International Journal of Women’s Dermatology

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A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis

Alexis,

Gooderham,

Kwatra

et al. 2024

Dermatol Ther (Heidelb)

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Introduction Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395). Methods Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years. Results A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100. Conclusion While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected.

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Treatment of Nail Psoriasis

Hwang,

Lipner

2024

Dermatologic Clinics

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Under-representation of racial and ethnic minorities in nail psoriasis randomized clinical trials: A call to action

Cited by 6 publications

References 5 publications

Evaluating minority representation across health care settings in hidradenitis suppurativa and psoriasis

Evaluating minority representation across health care settings in hidradenitis suppurativa and psoriasis

A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis

Treatment of Nail Psoriasis

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