A new prospective, observational study from the Lupus Research Alliance (LRA) aims to enroll 3,500 patients in an effort to accelerate the development of personalized treatments for individuals living with systemic lupus erythematosus (SLE).
The LRA on May 23 announced the launch of the Lupus Landmark Study (LLS). The study will be conducted in partnership with Lupus Therapeutics, the clinical research affiliate of the LRA.
The study will be a key feature of the Lupus Nexus, a unique combination of lupus patient registry, biorepository, and portal for data sharing and analysis.
“The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities,” according to the LRA press release.
“SLE is a debilitating autoimmune disease that disproportionately impacts women and people from minority groups, but the cause of lupus is unknown, and no single laboratory test can definitively identify lupus,” lead investigator S. Sam Lim, MD, of Emory University, Atlanta, told this news organization.
“Nevertheless, early detection and treatment can often lessen the progression and severity of the disease. Although there are numerous contributing factors to the lag in research discoveries and new treatments for patients with lupus, limited access to standardized, high-quality biological samples and natural history data provides a significant roadblock to advancing lupus research,” Dr. Lim said.
“Existing registry and biorepository resources in the lupus field are largely siloed, mostly limited to relatively small or discrete patient populations, and frequently not designed for broad sharing across all stakeholders of the research community,” Dr. Lim said. The LRA and its affiliate Lupus Therapeutics are committed to developing Lupus Nexus, a first-of-its-kind registry and biorepository, to serve as a collaborative research platform for lupus and a leading source of prospective, longitudinal patient data and biological samples for the research community, Dr. Lim added.
“The Lupus Landmark Study will form the foundation of this registry and biorepository and will provide a critical resource to enable the understanding of lupus heterogeneity at the molecular level,” Dr. Lim said. The molecular data can be linked to clinical phenotypes, he explained, “while providing an opportunity to better understand the holistic experience of patients with lupus, thus helping patients address the daily life challenges they face.”
The Lupus Accelerating Breakthroughs Consortium (Lupus ABC) was announced earlier this spring by the LRA. It represents a collaboration between the U.S. Food and Drug Administration and the lupus community to improve and accelerate the development of safer and more effective treatments for people with lupus, Dr. Lim said. “Data and other results from the LLS will inform this collaboration,” he said.
“The LLS will provide greater insight into the pathogenesis and evolution of the condition, providing much needed information and guidance to clinicians so that the disease can be detected and treated earlier and with better precision,” Dr. Lim said. “The partnership with patients will ensure that advances will not only be meaningful to clinicians but their patients and caregivers as well,” he added.
Individuals living with lupus were essential to the development of the Lupus Nexus, and patients will continue to be engaged through participation in the LLS, which will not only generate data to promote patient-centered treatments but will also give participants more insight into their health data, according to the LRA press release.
The clinical coordinating center and biorepository elements of the Lupus Nexus will be managed by Embleema and Azenta Life Sciences, respectively, according the LRA.
Biomarker analysis will be conducted by DxTerity Diagnostics via the company’s proprietary DxCollection MicroCollection Device and Modular Immune Profile platform.
The LLS is scheduled to begin enrolling patients through select academic medical centers in the Lupus Therapeutics Lupus Clinical Investigators Network later in 2023, with an expanded roll-out in 2024, according to the press release. More information about the Lupus Landmark Study is available from Lupus Nexus at LupusNexus@lupusresearch.org.
A version of this article first appeared on Medscape.com.