Lupus Nexus Builds a 3,500-Patient SLE Research Platform
Key Takeaways
- Lupus Nexus integrates the prospective Lupus Landmark Study with a clinical coordinating center, biorepository, and DREAM data platform to link longitudinal clinical, patient-reported, biospecimen, and molecular data in systemic lupus erythematosus.
- As of March 25, 2026, 705 participants had enrolled across four cohorts: 13.3% new-onset SLE, 23.3% active lupus nephritis, 27.4% extrarenal flare, and 35.0% prevalent SLE; enrolled participants included 37.6% Black, 38.0% White, and 12.6% Asian/Pacific Islander participants.
- Retention was 95% at 2.5 years, with more than 1,373 patient-reported outcome sets completed and 15,452 unique biospecimens collected, supporting ongoing longitudinal clinical and translational research.
Within Lupus Nexus and the Lupus Landmark Study, the Lupus Landmark Study serves as the prospective clinical component of the platform. Lupus Nexus also incorporates a clinical coordinating center, biorepository, and the Data Repository, Exchange, and Analytics platforM, or DREAM.
The Lupus Landmark Study is a prospective, longitudinal observational study designed to enroll approximately 3,500 adults with systemic lupus erythematosus at Lupus Clinical Investigators Network sites in the United States and Canada. Participants are enrolled into four cohorts representing new-onset SLE, active lupus nephritis, extrarenal lupus flare, and prevalent SLE and undergo longitudinal follow-up.
Eligibility includes adults aged 18 years or older who can provide informed consent and comply with study procedures. Participants can qualify on the basis of established SLE classification criteria, including the 2012 Systemic Lupus International Collaborating Clinics criteria, 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology criteria, or 1997 revised American College of Rheumatology criteria, or based on clinical assessment of SLE.
The study collects medical and treatment information, clinician-reported outcomes, patient-reported outcomes, social and environmental information, and longitudinal biospecimens. Biospecimen collections include blood-derived materials, urine, saliva, stool, and tissue, allowing clinical observations to be linked with biological measurements over time.
DREAM serves as the data infrastructure for Lupus Nexus, bringing clinical and biospecimen-derived data into a common research environment. The platform includes access mechanisms for researchers as well as patient-facing resources. Molecular analyses, including genomic, transcriptomic, proteomic, autoantibody, and other biospecimen-based assessments, are intended to expand the data available through the platform.
As of March 25, 2026, 705 participants had enrolled in the Lupus Landmark Study. Of those participants, 13.3% were enrolled in the new-onset SLE cohort, 23.3% in the active lupus nephritis cohort, 27.4% in the extrarenal flare cohort, and 35.0% in the prevalent SLE cohort.
The enrolled population included 37.6% Black participants, 38.0% White participants, and 12.6% Asian/Pacific Islander participants. These data describe the racial composition of the cohort at this stage of enrollment.
Longitudinal study operations included 95% retention at 2.5 years, more than 1,373 completed patient-reported outcome sets, and 15,452 unique biospecimens collected. Most recorded Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index values were low, and analyses of baseline molecular, autoantibody, and medication-level data were underway.
Follow-up and biospecimen collection vary according to cohort and clinical events. The study includes scheduled longitudinal assessments as well as additional evaluations associated with disease flares, allowing clinical changes to be paired with patient-reported and biological data. Lupus Nexus is designed to support research into SLE heterogeneity, biomarkers, disease trajectories, and treatment response as longitudinal clinical and molecular data accumulate.
Recruitment through participating lupus research centers may affect the representativeness of the enrolled population, and the observational design requires consideration of confounding and treatment-selection factors in future analyses of treatment response and clinical outcomes.
Lupus Nexus is structured as a shared research resource in which longitudinal clinical information, patient- and clinician-reported outcomes, biospecimens, and molecular data can be analyzed together. Biospecimen-derived data generated through the resource are returned to DREAM under the platform's data-sharing framework, allowing the dataset to expand as additional analyses are completed.
The platform has established enrollment across four predefined SLE cohorts, ongoing longitudinal follow-up, and accumulation of linked clinical, patient-reported, and biospecimen data. Continued enrollment and follow-up are expected to expand the resource for biomarker discovery, disease stratification, prediction, and treatment-response research.
Clinician Questions
Who is eligible for the Lupus Landmark Study within Lupus Nexus? The study enrolls adults aged 18 years or older who can provide informed consent and comply with study procedures. Participants can qualify based on established SLE classification criteria, including the 2012 SLICC, 2019 EULAR/ACR, or 1997 revised ACR criteria, or based on clinical assessment of SLE. Participants enter one of four cohorts: new-onset SLE, active lupus nephritis, extrarenal lupus flare, or prevalent SLE. Pregnancy at enrollment is an exclusion criterion.
What are the four Lupus Landmark Study cohorts? The study enrolls participants with new-onset SLE, active lupus nephritis, an extrarenal lupus flare, or prevalent SLE. The cohort structure captures patients at different stages and clinical states of the disease while allowing longitudinal follow-up.
How are flares and follow-up handled in the Lupus Landmark Study? Participants undergo cohort-specific longitudinal assessments, with additional evaluations associated with disease flares. These assessments allow changes in disease activity to be linked with clinical information, patient- and clinician-reported outcomes, medication data, and biospecimens collected over time.
What kinds of data and biospecimens are linked through Lupus Nexus? The platform collects longitudinal medical information, medication data, clinician-reported outcomes, patient-reported outcomes, social and environmental information, and biological specimens. Biospecimens include blood-derived materials, urine, saliva, stool, and tissue. DREAM provides the infrastructure for linking these resources with molecular data generated from biospecimen analyses.
What can Lupus Nexus support as longitudinal data accumulate? The linked clinical, patient-reported, biospecimen, and molecular data can support research into SLE heterogeneity, biomarkers, disease trajectories, disease stratification, prediction, and treatment response. The observational design requires appropriate methods to address confounding when evaluating treatment-response and clinical-outcome questions.