CAR-T Cell Therapy for Lupus at Sheba Medical Center, Israel

What is Lupus?

Lupus is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues, leading to widespread inflammation. It can affect various parts of the body, including the skin, joints, kidneys, heart, and lungs. Symptoms commonly include fatigue, joint pain, swelling, skin rashes (often a butterfly-shaped rash across the face), sensitivity to sunlight, and fever. The severity of lupus varies greatly, with some experiencing mild symptoms and others facing life-threatening complications. Early diagnosis and proper management are crucial for improving the quality of life of those affected by lupus.

CAR-T Therapy for Lupus at Sheba Medical Center

At the forefront of innovative treatment in Israel, Sheba Medical Center offers CAR T-cell therapy for lupus under the leadership of Prof. Merav Lidar, Director of the Rheumatology Unit. A renowned expert in rheumatology, Prof. Lidar also serves as the President of the Israeli Society of Rheumatology. She is an active member of the American College of Rheumatology and the ASAS group, with a vast background in clinical research. Her pioneering work in familial Mediterranean fever has earned her international recognition for improving patient outcomes. In 2024, Sheba Medical Center began offering CAR T-cell therapy for lupus, providing treatment to both Israeli and international patients. While local data is still emerging, the program is grounded in the expertise and global successes of CAR T-cell treatments for autoimmune diseases. The hospital draws upon international case studies and research to ensure high-quality care for patients with refractory lupus.

Groundbreaking Study of 15 Patients in Germany

A landmark study conducted at Friedrich-Alexander University Erlangen-Nürnberg and Universitätsklinikum Erlangen, Germany, between February 2021 and May 2023, explored the use of CD19 CAR T-cell therapy for patients with severe autoimmune diseases, including systemic lupus erythematosus (SLE), idiopathic inflammatory myositis, and systemic sclerosis. Published in The New England Journal of Medicine, the study followed 15 patients who were unresponsive to standard immunosuppressive therapies. The results were highly encouraging: all patients experienced significant clinical improvement, with SLE patients meeting DORIS remission criteria, myositis patients showing major clinical responses, and systemic sclerosis patients displaying decreased disease activity based on the European Scleroderma Trials and Research Group (EUSTAR) index. The study also found that B-cell depletion induced by CAR T-cell therapy lasted for approximately 112 days, after which B-cell populations reappeared in a healthier state. Patients were able to discontinue immunosuppressive medications, and long-term follow-up showed sustained remission with minimal side effects. This case series highlights the potential of CAR T-cell therapy in treating refractory autoimmune diseases, though further clinical trials are needed to confirm its long-term efficacy and safety.

A Case Study of a 41-Year-Old Patient

One of the notable cases from the study involved a 41-year-old man with refractory antisynthetase syndrome, a rare autoimmune disorder affecting muscles, lungs, skin, and joints. The patient had previously undergone multiple treatments, including glucocorticoids, rituximab, and intravenous immunoglobulins, but his condition continued to deteriorate. He experienced severe muscle weakness, interstitial lung disease, and required oxygen support. As a last resort, the medical team at Friedrich-Alexander University initiated CD19 CAR T-cell therapy. Although the patient initially experienced a brief worsening of symptoms, his condition soon improved dramatically. He regained muscle strength, his respiratory function normalized, and key disease markers, such as creatinine kinase and anti-Jo-1 antibodies, significantly decreased. MRI scans confirmed the resolution of muscle and lung inflammation, demonstrating the effectiveness of CAR T-cell therapy in treating this previously untreatable condition. This case underscores the potential of CAR T-cell therapy to significantly improve outcomes in complex autoimmune diseases.

Publication in Pubmed by Prof. Lidar Merav