PALS program effective in ensuring diverse representation in lupus clinical trials

The Lupus Research Alliance and its affiliate Lupus Therapeutics presented data at ACR Convergence 2022 with results showing the effectiveness of a pilot peer education program called the Patient Advocates for Lupus Studies (PALS), in increasing knowledge, perception, and willingness among people with Systemic Lupus Erythematosus (SLE) to participate in clinical trials. Results of this study (Abstract #2245) offer promise especially among groups who are traditionally underrepresented in clinical studies, including those of Black ancestry.

We created the PALS program because of the need for equal representation in clinical trials by all those living with SLE, particularly given its greater prevalence among racial and ethnic minorities. Underrepresentation by people of color in clinical trials can lead to results that do not accurately reflect the effect of potential therapies among all patients, making it difficult for healthcare professionals to optimally manage their treatment."

Albert Roy, President and CEO, Lupus Research Alliance

According to a published analysis from Stanford University, white patients constitute 33% of SLE cases but represent 51% of participants in clinical trials, while Black patients make up 43% of SLE cases but comprise only 14% of trial participants.

Piloted at five academic medical centers belonging to Lupus Therapeutics' Lupus Clinical Investigators Network, the peer-to-peer clinical trial education program was co-designed with lupus patients to improve clinical trial awareness, knowledge, and enrollment, with a focus on ensuring diverse representation in lupus clinical trials. Lupus patients who had participated in a clinical trial were trained as peer educators to connect with clinical trial-naïve lupus patients. Drawing from their experience, the peer advocates effectively built awareness and understanding of the risks and benefits, empowering others to actively share in decision-making about participation in a future clinical trial, all while increasing patient diversity in research.

The research analysis was presented at ACR by Dr. Saira Sheikh, Vice-Chair of Lupus Therapeutics' Lupus Clinical Investigators Network. She is the Linda Coley Sewell Distinguished Professor of Medicine Rheumatology, Allergy & Immunology at University of North Carolina at Chapel Hill; Director, UNC Rheumatology Lupus Clinic; and Director, Clinical Trials Program at Thurston Arthritis Research Center.

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Dr. Sheikh detailed results of the study designed as a randomized pre-test/post-test evaluation of four outcomes related to trial participation: knowledge, attitudes, self-efficacy, and intentions among a diverse group of people with lupus -; 64 in the intervention group who received education from trained peer advocates versus the control group of 72 people who did not. Scores for all four measures were significantly higher among those who received training. There was also a high level of satisfaction with the program, particularly among people of color, suggesting a viable path forward in engaging this group in trials.

"This work serves as a model of patient-engaged research and provides evidence of a practical program that can be adapted and implemented to increase participation of underrepresented racial and ethnically diverse patients in lupus clinical trials," notes Dr. Sheikh.

In the second LRA study (Abstract # 2055), the LRA Lupus Industry Council presented its preliminary analysis of the two most common endpoints used to evaluate the effectiveness of new drugs for lupus in clinical trials -; the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA). Although many factors can contribute to the high failure rates of late-stage clinical trials in lupus, it is thought that the measurement tools currently used to assess the efficacy of tested drugs may be inadequate to fully capture the efficacy signals. As these two endpoints at times have not provided the same results within a trial, it raises questions on the utility of the measurement items included in these two endpoints-; which of those capture the efficacy of the drug and which contribute to noise or factors that distract from the outcome measure.

Using data from patients in placebo groups in lupus trials, participating companies compared the response for SRI-4 and BICLA and identified factors that drive their response and non-response. The analysis will detail what drives the two measurement tools to produce similar and divergent results. The goal is to better understand the fundamentals underlying the endpoints so that they can be improved and better employed in lupus clinical trials.