Racial and Ethnic Representation in Clinical Trials of Janus Kinase Inhibitors for Dermatologic Conditions: A...

Janus kinase (JAK) inhibitors represent promising therapies for dermatologic conditions, including psoriasis, hidradenitis suppurativa (HS), atopic dermatitis (AD), systemic lupus erythematosus (SLE), and vitiligo. There are little data available evaluating the composition of research cohorts for this emerging treatment modality. Adequate racial representation in clinical trials is essential.

To characterize the study populations of clinical trials for Janus kinase inhibitors for dermatologic indications.

Clinical trials were identified from January 2000 to March 2025 through PubMed using the following keywords: "Janus kinase inhibitor," "JAK inhibitor," "alopecia areata," "atopic dermatitis," "hidradenitis suppurativa," "systemic lupus erythematosus," "systemic sclerosis," "psoriasis," and "vitiligo." Additional trials were retrieved from ClinicalTrials.gov using the search term "JAK inhibitor." Each trial was reviewed for demographic data, including race and ethnicity. Additional variables collected included Fitzpatrick skin type and quality-of-life measures. The distribution of race among trial participants was compared to the current US population and the condition-specific prevalence data where available.

Of 399 identified studies, 207 clinical trials were included in our analysis, including 57,112 study participants were analyzed. Among studies reporting race (57.5%), representation was predominantly White (75.1%), followed by Asian (13.2%), Black (6.6%), American Indian/Alaska Native (0.48%), Native Hawaiian (0.11%), and multiple races (0.43%). Underrepresentation was pronounced among Black participants in psoriasis (1.3%), SLE (1.0%), and vitiligo trials (5.1%), although higher in HS (27.9%). Representation in these trials significantly differed from the racial distribution of US patients with vitiligo (P=0.012) and AD (P=0.00088). White patients were overrepresented in vitiligo and AD trials (Pearson residual=1.06, 2.71), while Black patients were underrepresented in these trials (Pearson residual=-2.66, -2.14). Additionally, a minority of studies (28.98%) reported on QoL metrics, which are essential tools for measuring disease burden and impact on patients.

Reporting on racial data, Fitzpatrick skin type, and quality of life measures is lacking in clinical trials for Janus kinase inhibitors. These factors play a key role in addressing comorbidities and mitigating disease burden. These findings highlight a need for improved recruitment strategies targeting underrepresented populations in dermatologic clinical research.  .