- The Lupus Landmark Study, the largest prospective observational study in lupus, will enroll 3,500 patients throughout North America over five years
- The Lupus Landmark Study is a key component of the Lupus Nexus, a first-of–its-kind in lupus registry, biorepository and data/knowledge portal
NEW YORK, NY (May 23) – The Lupus Research Alliance and its clinical research affiliate Lupus Therapeutics today announced the launch of the Lupus Landmark Study, a groundbreaking observational research study to accelerate the development of personalized treatments for people living with lupus. The Lupus Landmark Study, the largest study of its kind in lupus, will prospectively recruit and longitudinally follow 3,500 adults diagnosed with systemic lupus erythematosus (SLE). The Lupus Landmark Study is a key component of the Lupus Nexus, a state-of-the-art, patient-centric, collaborative research resource.
The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities. The platform will provide a collaborative solution that is inclusive of diverse patient populations disproportionally affected by lupus. The Lupus Nexus will be a source of highly curated clinical data, patient reported data, biological samples, and raw analyzed data to catalyze global collaboration, innovation, and precision medicine approaches in lupus.
“We are thrilled to launch the Lupus Landmark Study as the first phase of the Lupus Nexus,” said Teodora Staeva, PhD, VP and Chief Scientific Officer of the Lupus Research Alliance. “This is a significant milestone for the lupus community and an opportunity to enable major breakthroughs in our understanding and treatment of lupus. We are immensely grateful to all our collaborative partners who have brought us to this stage, including people with lupus, clinicians, researchers, industry, government, and non-profit entities.”
People with lupus have played a key role in the development of the Lupus Nexus and will continue to be at the core of this effort through their participation in the Lupus Landmark Study. Their engagement will generate the data needed to drive patient-centric treatments as well as allow participants greater visibility into their own personal health data.
“Not only is it important to understand lupus from the vantage point of each person living with this disease, but it’s important that researchers and patients have a voice in these important initiatives,” said Ruth Wilson, member of the Lupus Nexus Steering Committee and the Executive Committee of LRA’s Young Leaders Board. “It’s exciting to see this study come to life and an honor to provide my perspective and feedback as both a researcher and lupus patient advocate.”
The Lupus Nexus will support both discovery and clinical development research. Scientists will correlate deidentified data from the Landmark Study with analyzed biosample data to identify or validate drug targets, biomarkers, and hypothesis, with the goal of ultimately understanding disease heterogeneity and developing more effective diagnostic, prognostic, and treatment approaches for lupus.
“A critical part of unlocking new insights into this complex disease is greater collaboration and data sharing among the global lupus research community,” said S. Sam Lim, MD, MPH, lead investigator of the Lupus Landmark Study, and Professor of Medicine, Emory University and Chief of Rheumatology at Grady Memorial Hospital. “My hope is that with the Lupus Landmark Study and the Lupus Nexus, we’ll not only have better data, but we’ll be able to better collaborate to find more treatments that will enable more personalized care for people with lupus.”
In addition to the Lupus Landmark Study, other key structural components of the Lupus Nexus include its clinical coordinating center, biorepository, and data/knowledge portal. The Lupus Research Alliance has engaged Embleema and Azenta Life Sciences as the clinical coordinating center and biorepository, respectively. DxTerity Diagnostics, Inc. will conduct biomarker analysis using their proprietary DxCollection MicroCollection Device and Modular Immune Profile (MIP) platform.
The Lupus Landmark Study and Lupus Nexus are part of the Lupus Research Alliance’s bold Strategic Plan for Research that addresses critical needs for advancing research, including defining lupus heterogeneity, stratifying patients by active disease mechanism, and establishing motivated and collaborative global research/technology teams.
The Lupus Landmark Study will begin enrolling in select academic medical centers in the Lupus Therapeutics Lupus Clinical Investigators Network (LuCIN) later this year with expanded roll-out in 2024. To find out more information about the Lupus Landmark Study, please contact the Lupus Nexus team at LupusNexus@lupusresearch.org.
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. Black/African American, Hispanic/Latino, Asian, and Native American populations 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 support lupus research programs. Visit LupusResearch.org to learn more, and follow us on LinkedIn, Twitter, Facebook, and Instagram.
About Lupus Therapeutics
Lupus Therapeutics, an affiliate of the Lupus Research Alliance, 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. Visit LupusTherapeutics.org to learn more.
Thanks go to the following companies for their sponsorship support of the Lupus Landmark Study and Lupus Nexus development:
Bristol Myers Squibb, GSK, AbbVie Inc., and EMD Serono Inc.