Racial and ethnic disparities in clinical research and the dermatology workforce: Part 2

Omar, Deega; Syder, Nicole; Brown-Korsah, Jessica; McKenzie, Shanice A; Elbuluk, Nada; Taylor, Susan C.

doi:10.1016/j.jaad.2022.03.052

Cited by 4 publications

(4 citation statements)

References 27 publications

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“…Factors that may play a role in the lack of minority involvement in clinical trials are the historical mistreatment of racial/ethnic minorities in clinical trials such as the Tuskegee Syphilis Study, lack of enrollment targets, lack of advertising in communities through religious venues like churches and mosques, or cultural events, and disparities in research investigators [5, 6]. In 2020, only 1.8% of National Institutes of Health (NIH)-funded research investigators were Black, 4.8% were Hispanic, and 22% were Asian [7].…”

Section: Discussionmentioning

confidence: 99%

Racial and Ethnic Diversity in Janus Kinase Inhibitor Alopecia Areata Clinical Trials: A Systematic Review

Ezemma¹,

Devjani²,

Jothishankar³

et al. 2023

Skin Appendage Disord

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Background: Alopecia areata (AA) is a chronic autoimmune disease that causes non-scarring alopecia. A few studies have shown increased odds of AA in Black individuals compared to White individuals and increased odds of AA in Latinos compared to non-Latinos. Another study showed that Asians have lower odds of AA compared to Whites. Baricitinib, a Janus kinase inhibitor (JAKi), became the first Federal Drug Administration (FDA)-approved medication for adult patients with severe AA in June 2022. Objectives: The aim of this review was to analyze published JAKi AA randomized controlled trials to characterize and assess the racial and ethnic representation of participants. Animal studies, studies unrelated to AA, and studies not investigating JAKis were excluded. Methods: PubMed and clinicaltrials.gov were searched for systematic reviews of clinical trials between 1990 and 2022. Results: Six clinical trials were included with a total of 1,690 subjects. Four trials were industry-sponsored, while two were university-sponsored. The three largest races represented included White (59.9%), Asian (28.0%), and African American/Black (8.1%). Three out of the 10 patients identified as Hispanic. None of the trials included sub-analyses of clinical efficacy based on race and/or ethnicity. Conclusions: Our results show that populations with lower odds of AA (Whites and Asians) are overrepresented in JAKi AA clinical trials compared to Black and Hispanic/Latino patients.

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Section: Discussionmentioning

confidence: 99%

Racial and Ethnic Diversity in Janus Kinase Inhibitor Alopecia Areata Clinical Trials: A Systematic Review

Ezemma¹,

Devjani²,

Jothishankar³

et al. 2023

Skin Appendage Disord

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“…Generalizability to underrepresented racial and ethnic populations is unclear. Future trials should aim to increase diversity among clinical research participants …”

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confidence: 99%

“…Future trials should aim to increase diversity among clinical research participants. 12 Psoriasis is a complex and systemic clinical disease that affects patients of all ages. Based on the clinical trials by Lebwohl et al, roflumilast cream is a promising addition to the psoriasis armamentarium, potentially filling an important treatment gap.…”

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confidence: 99%

Roflumilast for Chronic Plaque Psoriasis

Cordoro

2022

JAMA

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Plaque psoriasis is a multisystem inflammatory disease that affects children and adults. Skin lesions are the most prominent manifestation, appearing as localized or widespread red plaques with silvery scale. Psoriasis may be associated with arthritis, obesity, metabolic syndrome, psychiatric disease, impaired quality of life, and increased risk of cardiovascular disease. 1 The etiology and precise pathogenesis of psoriasis remain unclear. Treatment selection depends on body surface area affected, lesion characteristics (thickness, location), symptoms such as itch and pain, and comorbidities. Topical medications are prescribed in almost all cases, alone or in combination with other therapies. 2 Complex topical regimens using several drugs are often prescribed because different body sites have unique characteristics (skin thickness, hair, skin-to-skin occlusion) that require different vehicle formulations (cream, ointment, oil, foam) and alternating treatment schedules to increase effectiveness and reduce toxicity. 3 As opposed to new systemic agents, few new topical treatments for psoriasis have been identified in the recent past. Prior to 2022, when the US Food and Drug Administration (FDA) approved tapinarof (in May), an aryl hydrocarbon receptor modulating agent for adults, and roflumilast, a PDE4 inhibitor for adults and children 12 years and older (in July), there has not been a new topical mechanism approved for psoriasis in more than a decade. A topical PDE4 inhibitor, crisaborole, and an oral PDE4 inhibitor, apremilast, are currently FDA approved for treatment of atopic dermatitis in patients aged 3 months and older and treatment of psoriasis in patients aged 18 years and older, respectively.In this issue of JAMA, Lebwohl and colleagues 4 present data from the PDE4 Inhibition with Roflumilast for the Management of Plaque Psoriasis (DERMIS-1 and -2) clinical trials. These identically designed, randomized, double-blind, vehicle-controlled phase 3 trials randomized a total of 881 patients to test the safety, efficacy, and patient-reported outcomes of the PDE4 inhibitor roflumilast cream, 0.3%, compared with vehicle, applied once daily to plaque psoriasis for 8 weeks. Participants were aged 2 years and older (mean age, 47.5 years) with plaque psoriasis involving the face, extremities, trunk, or intertriginous areas affecting 2% to 20% of body surface area (BSA) and a minimum of mild disease as defined by the Investigator Global Assessment 5 (IGA) and the Psoriasis Area and Severity Index 6 (PASI). The IGA and PASI are investigator-reported scales used in clinical trials to measure severity and extent from 0 (clear) to 4 (severe) and 0 (no disease) to 72 (maximal disease), respectively. Itch and other patient-reported symptoms and experiences are captured with Worst Itch Numerical Rating Score 7 (WI-NRS) and

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“…Dermatologist Dr. Albert Kligman, in cooperation with the NIH, U.S. Army, and pharmaceutical companies, oversaw the Holmesburg Prison Experiments from 1951 to 1973, which investigated topical treatments and chemical warfare. A disproportionate number of imprisoned subjects were Black men who were denied informed consent 6 . In 1976, the Belmont Report was formed to dictate basic ethical principles (respect for persons, beneficence, and justice) that must be respected when conducting research with human subjects.…”

mentioning

confidence: 99%