Dr. Lipner says that primary investigators and sub-investigators can advocate for the diversification of clinical trial participants.
Though nail psoriasis is not featured as prominently as other forms of psoriasis in clinical trials, it is a condition that will affect roughly 80-90% of all skin psoriasis patients at some point in their lifetime. Additionally, patients with psoriasis with nail findings are more likely to have underlying sporadic arthritis, and are candidates for more aggressive with biologic or systemic therapy.
Despite this, data on how nail psoriasis affects patients with skin of color is scarce.
In an interview with HCPLive, Shari Lipner, MD, PhD, Associate Professor of Dermatology at Weill Cornell Medicine, spoke of racial and ethnic underrepresentation in nail psoriasis trials and skin trials in general, and what could be done to promote more inclusive clinical trials.
Lipner and an investigative team reviewed 45 nail psoriasis clinical trials, which featured a total of 13,000 trial participants. Of the 45 studies selected during the review, 16 (36%) reported race and/or ethnicity with 15 (33%) reporting race alone, and only 1 (2%) reported both race and ethnicity.
This lack of diversity in clinical trials has implications that go beyond data on disease severity, as Lipner noted.
“Clearly, there are differences in the way psoriasis may affect different races in terms of severity, (and) it also may affect the uptake of treatments and response to treatments,” Lipner said. “I could just add that there is inter-racial and ethnic variability that affects the response to one-fifth of newly approved FDA medications, so we don't really know how different races will respond to the nail psoriasis treatments that we give.”
Though the National Institutes of Health legislation has recently mandated diversification across research cohorts for new psoriasis trials, which includes psoriatic arthritis and nail psoriasis, Lipner added that institutional change could be made on a local and individualized level.
“I think individual dermatologists can make a big difference,” Lipner said. “The study primary investigators, as well as the sub investigators, can advocate that there should be diversification of clinical trial participants. So, I think there's actually a lot we can do to change things in future trials.”
To hear more from Dr. Lipner, watch the video interview above.