Non-white subjects are underrepresented in phase III trials for psoriasis treatments
Plaque psoriasis is a common chronic inflammatory skin disease. Treatment for plaque psoriasis includes oral systemic, topical, and biologic medications. Although biologic therapies continue to be increasingly utilized in treating moderate-to-severe psoriasis, evidence has shown that non-white ethnicity is associated with a reduced likelihood of responding to biologics up to one year in patients with psoriasis. A recent cross-sectional literature review revealed a lack of diversity in subjects included in phase III clinical trials for the treatment of psoriasis.
The selected trials evaluated eleven biologic medications, one phosphodiesterase type-4 inhibitor, ten topical, and two oral systemic agents currently approved for the treatment of plaque psoriasis in adults. Of note, only sixty-two of the eighty-two trials reported ethnoracial data of subjects with the majority of these without comprehensive data. In total, 85.8% of enrolled subjects were white, highlighting a severe underrepresentation of people of color.
Increasing diversity in future clinical trials is critical.
For example, estimates have shown that approximately one-fifth of newly developed medications demonstrate interracial/ethnic variability in regard to various factors such as pharmacokinetics, safety and efficacy profiles, dosing, and pharmacogenetics. This research letter highlights the importance of new strategies to diversify clinical trials and data registries. The authors conclude the importance of increasing recruitment of people of color, employing community partners in marginalized communities to enhance recruitment efforts, and funding the provision of translation services during the recruitment and informed consent processes whenever necessary to ensure equitable distribution of resources globally.
Byline: Sarah B.W. Patton, MSHS, PA-C
Posted September 8, 2020
Reference: Reddy VD, Myers BA, Chan SU, Thibodeaux QG, Brownstone ND, Bhutani T et al. A review of current phase III clinical trials of plaque psoriasis: Underrepresentation of non‐white subjects and need for reform. British Journal of Dermatology 2020; Epub ahead of print.