ACR Convergence 2022 Included LRA-Authored Research on Measures to Demonstrate Treatment Efficacy for Patients with Lupus

NEW YORK, NY–November 8, 2022 — The Lupus Research Alliance and its affiliate Lupus Therapeutics will present 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 intentions 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,” said Albert Roy, President and CEO, Lupus Research Alliance. “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.”

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.[1]

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 will be 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.

Dr. Sheikh will detail 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 will present 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.

Abstracts:

2245: Feasibility and Efficacy of a Peer Education Program to Improve Patient Engagement in Lupus Clinical Trials 114 Nutter Theatre, Mon. Nov. 14, 5:00pm – 5:10pm ET

 2055: SRI-4 and BICLA: How Well Do They Agree Across Trials of Active Systemic Lupus Erythematosus? Virtual Poster Hall, Mon. Nov. 14, 1:00pm – 3:00pm ET

More than thirty researchers will also present at ACR data from intriguing foundational research funded by the Lupus Research Alliance that point to possible causes of lupus as well as pathways for potential treatments.

About Lupus
Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. Nine out of 10 people with lupus are women; lupus most often strikes during the childbearing years of ages 15 to 45. African Americans, Latinx, Asians, and Native Americans are two to three times at greater risk than Caucasians. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints.

About the Lupus Research Alliance
The Lupus Research Alliance (LRA) is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the LRA board of directors funds all administrative and fundraising costs, 100 percent of all donations supports lupus research programs.

About Lupus Therapeutics
LRA’s affiliate Lupus Therapeutics aims to accelerate drug discovery and diagnostic innovation for all patients living with lupus. Lupus Therapeutics collaborates with biotechnology and pharmaceutical partners through its unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization aims to place the patient voice and community stakeholders at the center of the clinical research process with the most innovative and renowned experts throughout North America.

Contact:
Caren Begun, TellMed Strategies at 201-396-8551 or caren.begun@tmstrat.com
Margy Meislin, Lupus Research Alliance at mmeislin@lupusresearch.org

[1] Falasinnu T, Chaichian Y, Bass MB, Simard JF. The Representation of Gender and Race/Ethnic Groups in Randomized Clinical Trials of Individuals with Systemic Lupus Erythematosus. Curr Rheumatol Rep. 2018 Mar 17;20(4):20. doi: 10.1007/s11926-018-0728-2. PMID: 29550947; PMCID: PMC5857270.