Diversifying psoriasis trials to expand clinical knowledge | Takeda Stories
Diversifying psoriasis trials to expand clinical knowledge
Above photo courtesy of IFPA project ‘All the colors we are’, February 2024, International Federations of Psoriasis Associations, Stockholm Sweden
This information is available to the public for information purposes only; it should not be used for diagnosing or treating a disease. This information is not intended to substitute consultation with a healthcare provider. If you or a loved one is concerned about psoriasis, please consult your healthcare professional.
Takeda does not have any product approved for the treatment of psoriasis at the time of this publication and there's no assurance of approval for such products in the future. The investigational compound TAK-279 has not been approved for use or validated by the U.S. Food and Drug Administration, the European Commission/ European Medicines Agency or any other regulatory authority.
When Chesahna Kindred was training to become a dermatologist, she looked to medical literature and textbooks for guidance on treating psoriasis in people like her who have black or brown skin.
She reflects, “The information wasn’t there. When their skin doesn’t look like the photos in textbooks, patients of color with psoriasis can be overlooked or misdiagnosed with a host of other conditions. My goal became to give all patients an accurate and timely diagnosis.”
Kindred is now a board-certified dermatologist whose practice serves patients in the greater Baltimore, Maryland, area. She also serves as an investigator for clinical trials for Takeda and other companies.
“Clinical trials can lead to peer-reviewed scientific publications,” she says. “Once validated, those publications can form the basis of textbooks. Those textbooks and publications become important resources for both new and practicing healthcare providers. And, new evidence and new understanding can lead to new clinical care and treatment approaches for patients.”
When patients of color with psoriasis face barriers to seeking treatment, dermatologists don’t gain necessary experience and knowledge in regard to the treatment of these populations. Diversifying clinical trial participation can broaden the body of knowledge in dermatology. The International Psoriasis Council notes that “most clinical trials for psoriasis treatments have been performed in white individuals.” A systematic review investigating the diversity of dermatology clinical trials discovered that US psoriasis studies reporting or capturing race had 84.3% white participants.1,2
"Clinical trials can lead to peer-reviewed scientific publications. Once validated, those publications can form the basis of textbooks. Those textbooks and publications become important resources for both new and practicing healthcare providers. And, new evidence and new understanding can lead to new clinical care and treatment approaches for patients.”
Dr. Chesahna Kindred, M.D., M.B.A., F.A.A.D., Dermatologist and a paid consultant and investigator for Takeda
Dermatologist Warren Winkelman, M.D., Ph.D., who leads the Takeda Global Medical Affairs team for Dermatology, points out that when patients of color don’t see themselves in psoriasis information and don’t believe they could have the condition, this can lead to a “vicious cycle of denial, suffering and stigma. Lack of awareness and underreporting of symptoms can lead to missed diagnosis and delayed treatment, which results in worsening of patient outcomes.”
Diversifying participation in psoriasis clinical trials is essential, he says, because “trials are crucial learning opportunities, challenging unconscious biases and overcoming uncertainty with proof.”
Given Takeda’s legacy of innovating on behalf of patients, Dr. Winkelman adds that Takeda has launched Phase 3 trials in psoriasis for its investigative oral therapy, TAK-279, and that “From the start, our ambition is to have unprecedented patient diversity in our Phase 3 trials, so our trials closely reflect the real world.”
“From the start, our ambition is to have unprecedented patient diversity in our Phase 3 trials, so our trials closely reflect the real world.”
Dr. Warren Winkelman, M.D., Ph.D., Takeda Global Medical Affairs lead for Dermatology
Monica Merino-Lopez aims to help Takeda achieve that goal. She is a site manager for Direct Helpers, a clinical trial research organization in the diverse community of Hialeah, Florida, and one of the trial sites for TAK-279. She believes it is important for patients with skin of color and diverse backgrounds to see themselves in the health information they encounter and “to be truly seen and heard in clinical trials.”
Monica Merino-Lopez, Site manager for Direct Helpers clinical trial research organization, and a paid consultant for Takeda
So how does Merino-Lopez approach diverse trial enrollment?
“Communicating with transparency and setting expectations are key to building trust with patients,” which enables informed and appropriate recruitment for clinical trials, Merino-Lopez says. “I do that with my community, and Takeda has done that with me. We are trying to make things better for the patients as we work together to create these diverse clinical trials. After all, clinical research is here for the good of all people.”
To support trial sites in serving diverse patients, Dr. Winkelman says that “we’re supporting study investigators by sharing best practices to promote inclusivity in our trials.”
Dr. Kindred, who serves as an investigator in the clinical studies on TAK-279 in psoriasis, describes those efforts as a “serious and real commitment to diversifying clinical trials,” that can, in turn, contribute to the evidence and education needed to inform clinical practice.
She says she is hopeful about what diverse trials can mean for dermatologists and their patients.
“We need to address the science to learn about patients who’ve been underserved," Dr. Kindred says. “Diversifying clinical trials – that’s how you start to eat that elephant, to generate the evidence that’s needed.”
Prevalence, Clinical Presentations, Disease Severity Appreciation, and Assessment of Psoriasis in the Context of Skin of Color. International Psoriasis Council. Accessed February 16, 2024. https://psoriasiscouncil.org/expert-insights/skin-of-color-psoriasis-disease-severity-assessment/
Charrow A, Xia FD, Joyce C, Mostaghimi A. Diversity in dermatology clinical trials: a systematic review. JAMA Dermatol. 2017;153(2):193-198. doi: 10.1001/jamadermatol.2016.4129.
