Session Type: Abstract Submissions (ACR)
Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by loss of tolerance to nuclear self-antigens, production of pathogenic autoantibodies and damage tomultiple organs. While corticosteroids and immunosuppressive agents have improved the outcome of patients, there remains a significant unmet need for safe and more effective treatments. Low-dose Interleukin-2 (IL-2) therapy has recently been shown effective to treat autoimmune disease. We aimed to assess the safety and efficacy of low-dose IL-2 therapy in active SLE.
We conducted a clinical trail on active SLE patients (NCT02084238). A total of 40 patients were enrolled. Patients with SLE Disease Activity Index (SLEDAI) scores ≥8 received three courses of low dose recombinant human IL-2 (1 million IU every second day for 2 weeks followed by a 2-week hiatus). The primary end point was the response rate at week 10. Both the safety and efficiency of IL-2 therapy were evaluated.
Total 36 patients(36/40, 90%) achieved an SLE Responder Index (SRI) improvement at week 6. No patients demonstrated high grad adverse events; mild injection-site reaction was observed in 5 patients (5/40, 12.5%). Better response was seen in patients with skin involvement (erythema, photo sensibility, Rdynolds, vasculitis), hematologic abnormities (leukopenia, Thrombocytopenia and anemia) and disease-related fever.Patients showed the improvement of major laboratory indicators, including reduced anti-dsDNA autoantibody titres and 24-hour proteinuria, and increased levels of the complement proteins C3 and C4. Immunological analysis showed significant increase of Treg cells and decrease of effector helper T cells after the therapy.
Our results showed that low-dose IL-2 therapy in active SLE was safe and achieved satisfactory efficacywith increasing Treg and decreasing effector helper T cells.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficiency-of-low-dose-interleukin-2-treatment-in-systemic-lupus-erythematosus/