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Diversifying Lupus Clinical Trials One Patient at a Time

October 05, 2022
by Jane E. Dee

Diversifying clinical trials that are geared toward people with rheumatic and dermatologic diseases, including lupus, is a goal of the faculty leaders of Yale School of Medicine’s combined rheumatology/dermatology clinic.

Fotios Koumpouras, MD, associate professor of clinical medicine (rheumatology), and Sarika Ramachandran, MD, associate professor of dermatology, are cofounders the rheumatology/dermatology clinic. Koumpouras, who is also the director of the Lupus Program at Yale School of Medicine, oversees ongoing clinical and translational research, with the goal to better understand the causes of lupus, and to advance treatment.

A First in Connecticut

Yale’s rheumatology/dermatology clinic was the first of its kind in Connecticut when it began five years ago. Since them, its rheumatologists and dermatologists have seen hundreds of patients, many of whom were referred to them for clinical trials. The patients treated at the clinic have skin disease due to systemic diseases such as lupus, which preferentially affects people of color. These individuals often are referred to the clinic after they have tried other treatments without success, such as immunosuppressive drugs, and are seeking other options.

Overcoming barriers to clinical trials in communities of color, including distrust of the medical establishment, is a key goal of the clinic's. Ramachandran and Koumpourus aim to do this by building on the trust that develops between them and their patients at the clinic.

“One of the fundamental reasons that we are struggling with diversity in clinical trials is because there is distrust. And I think the unique part of our program is that we have a clinic where it's not just one, but two clinicians working together,” Ramachandran said. “And when there are these clinical trials that our patients qualify for, it's really exciting for all of us.”

The dearth of diverse patients in clinical trials, including in lupus, is well documented in medical literature, Koumpouras added. “This is a larger issue in terms of clinical trials, that is, we need to be sure results of clinical trials are reflective of the true diversity of patients you typically see sitting in the clinic,” he said.

By diversifying the clinic's clinical trials, the clinic will better be able to engage with its community of patients, "so that we are actually benefitting our community, and having close interpersonal relationships with our community members so that there is a good sense of trust,” Ramachandran said.

Another goal of the clinic's is to develop a registry of its patients who have cutaneous lupus, a skin disease in lupus, in order to alert them to upcoming clinical trials.

Rheumatology/Dermatology Conference Furthers Education

The rheumatology/dermatology clinic serves as a complex referral center for patients who have diseases that affect them dermatologically but are systemically involving rheumatology. The clinic focuses on lupus, an autoimmune disease; morphea, a rare condition that causes discolored patches on the skin; scleroderma, a group of diseases that involves the hardening and tightening of the skin; and dermatomyositis, an uncommon inflammatory disease marked by muscle weakness and skin rash. Lupus and cutaneous lupus are the most common diseases the clinicians treat.

To help educate other clinicians about these diseases, and to receive input on difficult cases, Koumpouras and Ramachandran launched a rheumatology dermatology conference in 2015. The interdisciplinary conference attracts faculty and trainees from both departments as well as from pathology and other medical specialties at Yale School of Medicine. Four to six conferences are held each year, highlighting different cases and diseases.

Submitted by Jane E. Dee on October 05, 2022