CAR-T cells improve rheumatoid arthritis in all 6 patients; 3 stop medication

CAR-T cell therapy reduced disease activity in all 6 patients with refractory rheumatoid arthritis, and 3 of them stopped taking medication.

The findings were published on the 27th in the international journal Nature Medicine. Researchers at Charité – Universitätsmedizin Berlin in Germany reported results from a clinical trial of CAR-T cell therapy in patients with refractory rheumatoid arthritis.

Rheumatoid arthritis is a chronic autoimmune disease in which the immune system attacks the body's joints, causing inflammation and swelling. Existing treatments suppress inflammation but do not cure the disease, so patients must take medication for life.

The researchers stopped all antirheumatic medications in 6 patients with severe, refractory disease, then administered a single dose of Kyverna-developed autologous fully human CD19 CAR-T cell therapy, miv-cel (miv-cel). The patients were followed for 36–52 weeks.

In terms of safety, all patients developed cytokine release syndrome (CRS), but it was mild, at grade 1 or 2. No neurotoxicity syndrome or serious adverse events occurred.

Regarding treatment effects, CD19-positive B cells decreased substantially in patients' blood and tissues, and autoantibodies also declined persistently. Four of the 6 patients tested negative for anti-mutated citrullinated vimentin (ACPA) antibodies, and 5 tested negative for rheumatoid factor IgM.

Despite discontinuing immunosuppressive treatment, disease activity improved in all 6 patients. The median DAS28-CRP score at the last follow-up decreased by 34%, and 3 patients met the criteria for remission and the American College of Rheumatology 70% response.

The researchers said that CD19 CAR-T cell therapy "showed favorable short-term tolerability in patients with refractory rheumatoid arthritis" and noted that further research is needed.