Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

Abstract

<b><i>Introduction:</i></b> Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs). <b><i>Methods:</i></b> A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included. <b><i>Results:</i></b> Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with <1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; <i>p</i> < 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting (<i>p</i> < 0.05 all comparisons). <b><i>Discussion/Conclusion:</i></b> Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.

Where are the older adults? Age distribution of nail psoriasis randomized clinical trials’ participants: a systematic review

“…It is unknown whether therapeutic safety and efficacy data from NP clinical trials pertain to this population. In this letter, we present a subanalysis of our systematic review on the ethnoracial composition of NP randomized clinical trials (RCTs), 2 characterizing age distribution and participation of older adults in NP RCTs.…”

“…Using Preferred Reported Items for Systematic review and Meta‐analysis (PRISMA) reporting guidelines, we conducted a systematic review (PROSPERO protocol: CRD42020213662) 2 of RCTs examining pharmacologic treatments for NP and/or cutaneous psoriasis/psoriatic arthritis where a number of patients with NP was described. Variations of the terms “psoriasis” and “nails” were used to search MEDLINE via PubMed and Ovid on 2/12/2021, with no date restrictions.…”

“…Forty‐five published studies (1973–2020) comprising 12,943 participants were identified (Figure 1). 2 Mean age was 44.4 years (range 12–88). Overall, 30/45 (66.7%) did not include an upper age limit.…”

“…1 In these patients, psoriasis management is challenging. 2 Indeed, comorbidities, polypharmacy, drug interactions, and side effects are more frequent as well as conventional systemic treatments (methotrexate, cyclosporine, and acitretin) are often contraindicated and show a higher risk of adverse events or drug interactions. 2 We have read with great interest the article recently published by Ricardo et al 3 entitled "Where are the older adults?…”

“…2 Indeed, comorbidities, polypharmacy, drug interactions, and side effects are more frequent as well as conventional systemic treatments (methotrexate, cyclosporine, and acitretin) are often contraindicated and show a higher risk of adverse events or drug interactions. 2 We have read with great interest the article recently published by Ricardo et al 3 entitled "Where are the older adults? Age distribution of nail psoriasis-randomized clinical trials' participants: a systematic review" presenting a sub-analysis of a systematic review assessing the ethnoracial composition of randomized clinical trials.…”