An Ambition to Reflect Unprecedented Patient Diversity in Psoriasis Studies

^{(Photo courtesy of IFPA project ‘All the colors we are’, February 2024) International Federations of Psoriasis Associations, Stockholm Sweden}

Taking early action to help address health disparities in psoriasis 

Last year marked Takeda’s entry into dermatology. It was the first time the company shared results from a Phase 2b study in psoriasis of TAK-279, an investigational oral compound which is currently not approved for use by any regulatory authorities.

Since then, Takeda, a Japanese company that has been serving patients for over 240 years, has applied its extensive expertise in developing therapies for inflammatory diseases to shape a global development program for TAK-279. Takeda has adopted a listen and learn approach, working with the psoriasis community to understand how to support the millions of people worldwide living with psoriasis.

A core part of this effort has been to identify health inequities among individuals with psoriasis and take tangible actions to address health disparities that disproportionately impact underrepresented communities.

“We must first understand the needs of all patients in order to create more inclusive practices and develop innovative medicines that enable everyone to achieve their highest level of health, inclusive of their race, ethnicity, gender and location,” said LaShell Robinson, Head of Diversity, Equity & Inclusion in Clinical Research, Takeda. “As of June 2022, all our new clinical trials require a diversity action plan, and we are embedding diversity, equity and inclusion from the start of our Phase 3 TAK-279 trials before we even screen or enroll patients.”

Takeda’s ambition is to have unprecedented patient diversity in its Phase 3 trials in psoriasis, part of the Latitude Psoriasis program, to reflect the real-world population. The company hopes to fulfill this mission by fostering community partnerships and implementing strategies anchored in education, access and awareness.   

Disparities in dermatology 

These efforts will be particularly important in dermatology, where there are significant racial and ethnic disparities in care. Patients with skin of color[i] are historically underrepresented in dermatologic education and research.[ii] In fact, a systematic review of randomized controlled dermatology trials in psoriasis found them to be the least diverse, with 84.3% of total study participants recorded as ‘White’.[iii] These disparities can have a severe impact on patients’ outcomes and quality of life and must be addressed. A critical part of the solution includes evaluating the safety and efficacy of potential new therapies in all patients who could benefit.

“As a dermatologist, I have seen firsthand how the lack of diversity and inclusion in psoriasis clinical research can compromise access to care and result in errors and delays in diagnosis and treatment,” said Warren Winkelman, M.D., Ph.D., Medical Head for Dermatology, Takeda. “There’s so much to learn from diverse patients’ experiences and so much work to be done to address their unmet needs.”

Vital work is already being done by patient and professional organizations, including the International Federation of Psoriasis Associations (IFPA) and Skin of Color Society, to improve education about how psoriasis manifests among people with different skin types and to advance research to meet the needs of diverse populations. It is essential that companies, including Takeda, bolster these efforts and embed inclusivity throughout their ways of working.

“As a global organization representing all people with psoriatic disease, we call for the elimination of disparities in access to care and treatment,” said Frida Dunger, Executive Director, IFPA. “In collaboration with member associations and a global network of patients, our project, 'All the Colors We Are,' seeks to bring attention to the ways psoriatic disease presents on diverse bodies and uncover unmet needs in the journey to diagnosis. We believe companies, like Takeda, have an opportunity to promote diversity and close the diagnosis gap in psoriasis, starting with inclusive clinical research.”

Diversity, equity and inclusion in action

For Takeda, improving diversity, equity and inclusion begins with clinical trials and ensuring that programs accurately reflect the patient populations healthcare providers treat. To achieve this, Takeda established clear trial diversity goals based on real-world prevalence data and is implementing tools to actively track its progress.

Takeda prioritizes education, conducting sessions at investigator meetings to train medical professionals on accurately diagnosing psoriasis in skin of color. The company offers resources to study sites, such as multi-language and culturally sensitive educational toolkits on clinical research and training to support study staff to foster patient inclusivity within trials.

Through community engagement, Takeda identified community-based trial sites in diverse geographies and is working closely with organizations with missions to increase clinical research participation in historically underrepresented populations. The company prioritized study sites with greater ethnic and racial diversity by including an assessment of site-level diversity within its feasibility questionnaires, which evaluate the possibility of conducting trials at specific sites. Takeda also works with partners to develop culturally relatable patient materials, using imagery of psoriasis that reflects diversity of skin types within the patient population.

Striving towards improved care for all patients

It will be a marathon, not a sprint, but Takeda has the global scale and skillset required to make valuable contributions to patient care in dermatology. Instilling a culture of diversity and inclusion into the TAK-279 clinical research program is a critical step towards supporting different populations of patients with psoriasis and creating solutions that address their needs.

“We will partner with the psoriasis community, dermatologists and patients, whose support is essential to our clinical program, to ensure our trials reflect the real-world population,” said Dr. Winkelman. “Together, we strive towards greater health equity and improved treatment options to reduce the disease burden for everyone living with psoriasis.”

Visit booth #5115 to learn more about the ongoing Latitude Psoriasis Clinical Trials or click here.