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Since the first description of systemic lupus erythematosus (SLE) by Laurent Théodore Biett nearly two centuries ago, the medical community has achieved great strides in the understanding and management of lupus. Advances in drug therapies have improved morbidity and health-related
quality of life. That said, this enigmatic disease continues to challenge us to improve on early diagnosis, anticipating and preventing flare-ups, optimizing old and new drugs and, most importantly, finding a cure.
At Cleveland Clinic, specialists in our Lupus Clinic are collaborating to advance science and patient care with the goal of reducing and eventually eliminating the toll lupus takes on an estimated 5 million people worldwide.
Here are a few highlights of what we are doing in our Lupus Clinic.
Our multidisciplinary clinic operates under the direction of rheumatologist Emily Littlejohn, DO, MPH, in collaboration with Laura Provenzano, MD, a specialist in lupus nephritis. The clinic was born of the wish for closer collaboration among physicians who treat patients with complex disease and multiple organ involvement.
Lupus Clinic patients meet with both specialists on the same day, allowing for clear, immediate communication. This is especially important for patients with lupus nephritis, which can damage the kidneys and put patients at higher risk for some cancers and cardiovascular complications. Between 30% and 50% of patients with lupus will develop related kidney disease. It is the lupus manifestation that is most urgent to control.
Patients seen in the clinic also benefit through our team’s involvement in trials for lupus and lupus nephritis. They’re at the cutting edge of potential new research trials.
Within the 22,000-square-foot Cleveland Clinic BioRepository, the lupus biorepository banks blood and urine specimens of our lupus patients. Specimens are tagged with information about general health, lupus activity, smoking and recreational drug use, exposure to heavy metals and other substances, reproductive health history, medications and more. This provides longitudinal data on nearly 400 participating patients across multiple races and ethnicities.
This resource is invaluable. Uncommon diseases present challenges for collecting specimens longitudinally and for establishing cohorts. We collect specimens from a given patient about every six months – sometimes sooner if they’re experiencing a flare-up. This rich research platform has
provided insight into variables that affect lupus activity and can identify changes in markers for disease over time. It also provides blood and urine specimens for myriad future research projects.
The Lupus Clinic and the biobank also are resources for medical students and medical residents on rotation. Students get hands-on experience with lupus patients and have access to the biobank for use in clinical and translational research projects.
Two exciting new clinical trials are getting underway in fall 2023:
• Brain fog in lupus. Neuropsychiatric lupus (NPSLE) is among the most vexing conditions for patients and their physicians. A high percentage of patients with lupus experience the associated memory
problems, difficulty finding words and sense of decline in mental acuity. However, these symptoms do not always correlate with lupus activity in the blood, and the mechanisms involved are unknown.
NPSLE remains hard to define, diagnose and treat. ClearMEMory is a phase 1 randomized, placebo-controlled trial to test the safety and efficacy of memantine to treat cognitive impairment in systemic lupus erythematosus. The primary outcome is the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total index at 12 weeks in the memantine and placebo groups for those with substantial neuropsychiatric manifestations of lupus.
• CAR-T therapy in multi-organ disease refractory lupus. A pivotal study done in Germany under Georg Schett published in 2022 in Nature Medicine reported on five patients with severe lupus involving multiple organs who entered remission after receiving chimeric antigen receptor (CAR) T cell therapy. Cleveland Clinic will begin a dose-ranging study exploring the potential utility of depletion of CD19+ B cells and plasmablasts with CD19-specific CAR T cells to induce disease remission. CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus is a phase 1 study.
Our Lupus Clinic creates an environment that allows us to give today’s patients with SLE the best care available while we pursue the newest science and train the minds that will yield benefits for the
patients of tomorrow.