Lupus Landmark Study launched to improve research, personalized care

Study is part of Lupus Nexus, a first-of-its-kind registry and research resource

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by Mary Chapman |

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The Lupus Research Alliance (LRA) and its clinical research affiliate, Lupus Therapeutics, have launched the largest, long-term prospective observational study in lupus with the goal of developing new, personalized treatments for the chronic immune system disorder.

The Lupus Landmark Study is a key part of Lupus Nexus, a first-of-its-kind lupus registry and collaborative research resource. Researchers hope to begin enrolling 3,500 adult patients throughout North America later this year and follow them over five years to better understand the disease’s variability and the challenges patients face.

People with lupus have played a fundamental role in developing Lupus Nexus, which seeks to transform lupus study and treatment development through its global data exchange capabilities. It’s expected that patient engagement will help generate the data needed to better understand the disease’s impacts and develop personalized therapies.

“We are thrilled to launch the Lupus Landmark Study as the first phase of the Lupus Nexus,” Teodora Staeva, PhD, LRA’s vice president and chief scientific officer, said in a press release. “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 nonprofit entities.”

Enrollment will occur at a select group of academic medical centers that are part of the Lupus Therapeutics Clinical Investigator Network, with an expanded rollout planned for next year. Participants must be diagnosed with systemic lupus erythematosus, the most common form of the disease that’s often referred to simply as lupus, and be at least 18 years old at enrollment. They also must be able to attend required visits.

The study is expected to give investigators around the world access to much-needed biosamples along with corresponding medical and patient-reported outcomes data toward developing new precision treatments.

“Existing registry and biorepository resources are limited to small patient populations and typically not designed for broad sharing across all stakeholders of the research community. By creating a collaborative solution that is inclusive of diverse patient populations, the Lupus Nexus will fill an information void in the lupus research space,” Lupus Nexus Director Devon Kelly said in an email to Lupus News Today.

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With its curated clinical data, patient-reported data, raw analyzed data, and biological samples, the Lupus Nexus platform is expected to catalyze international collaboration, innovation, and precision medicine approaches. While its data will give scientists their primary datasets, Lupus Nexus intends to over time become the main source of data produced by the Landmark investigation and its biospecimens, as well as future studies LRA will launch, Kelly said.

“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.”

As part of the study, researchers will correlate de-identified data with analyzed biosample data to identify or validate biomarkers, treatment targets, and hypotheses.

Other key components of Lupus Nexus include its biorepository, clinical coordinating center, and data/knowledge portal.

Embleema, which has a precision medicine software platform, has been tapped as the platform’s clinical coordinating center, while Azenta Life Sciences will be its biorepository. Biomarker analysis will be conducted by DxTerity Diagnostics.

“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, the study’s lead investigator. “My hope is that with the Lupus Landmark Study and the Lupus Nexus, we’ll not only have better data, but we’ll also be able to better collaborate to find more treatments that will enable more personalized care for people with lupus.”

The Lupus Landmark Study and Lupus Nexus are part of the LRA’s Strategic Plan for Research. For more information, email [email protected].