March 28, 2024

Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, has announced an innovative expansion of the highly successful Patient Advocates for Lupus Studies (PALS) program with the introduction of a first-in-lupus “Trial Buddy” component made possible by a partnership with Bristol Myers Squibb. The Trial Buddy addition provides extra support to people with lupus while they are involved in the Phase 3 POETYK SLE trials to evaluate how personal interaction can impact study retention and participation.

PALS, a peer-to-peer clinical trial early 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. As part of the program, individuals living with lupus who have participated in clinical research are trained to serve as peer educators to those who have never been in a trial.  Many trials struggle to recruit enough participants and often do not represent the diverse groups most affected by lupus. 1,2 Insufficient enrollment and under-representation by people of color in clinical trials can lead to results that do not accurately reflect the effect of potential therapies among all patients.1,3  The pilot PALS program successfully met its objectives to increase knowledge, attitudes, and intentions among people with lupus to participate in clinical trials.

PALS Expansion Increases People Reached
Now that it has been proven effective, the PALS program will expand and provide similar peer education at Yale University, University of Texas Southwestern Medical Center, and Oklahoma Medical Research Foundation in addition to Emory University, one of the original sites. Increasing the number of sites aims to extend the demonstrated benefit of the program to foster greater and more diverse participation in lupus trials.

The new Trial Buddy program will also be implemented at these four sites, as well as Columbia University, to enable PALS to assist adults living with lupus who are enrolled in the POETYK SLE clinical trials. These Phase 3 trials are evaluating deucravacitinib as a potential treatment for active systemic lupus erythematosus. To prepare for meaningful interactions with the trial participants, the PALS have received additional training in clinical trials and the POETYK SLE trials specifically. Independent of the formal clinical protocols for POETYK SLE, the PALS will be equipped to provide their assigned Trial Buddy with resources and answer any questions related to participation in the study. Each PAL will have regularly scheduled check-ins with their Trial Buddy to provide consistent support throughout the course of the trial.

Alyssa Johnsen, MD, PhD, vice president and head of late clinical development, Immunology at Bristol Myers Squibb noted, “We are proud to partner with the Lupus Research Alliance to bring forth innovative initiatives like the Patient Advocates for Lupus Studies program and look forward to piloting its use in the POETYK SLE Phase 3 trials.”

Lupus Therapeutics Executive Vice President Stacie Bell, PhD commented, “The aim of the Trial Buddy program is to encourage and support continued participation throughout clinical studies. This approach will be evaluated in association with the POETYK Phase 3 trials and may be expanded for use to increase diverse participation in other lupus trials.”

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References:

1. The Society for Women’s Health Research. (2011). Dialogues on Diversifying Clinical Trials:Successful Strategies for Engaging Women and Minorities in Clinical Trials.September 22-23, 2011.
2. Mitka, M. (2011). Treatment for lupus, first in 50 years, offers modest benefits, hope to patients. JAMA, 305(17), 1754-1755.
3. Dirks N. L., et al. Pharmacokinetics of immunosuppressants: a perspective on ethnic differences. Int J Clin Pharacol Ther. 2004 Dec; 42(12):701‐18