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Abstract Number: 665

Safety and Efficiency of Low-Dose Interleukin-2 Treatment in Systemic Lupus Erythematosus

Jing He1, Xia Zhang2, Xiaolin Sun3, Jianping Guo3, Yunbo Wei4, Zhaohua Hou4, Yu Di5 and Zhanguo Li3, 1Department of Rheumatology & Immunology, Peking University People's Hospital, Beijing, China, 2Department of Rheumatology & immunology, Peking University People's Hospital, Beijing, China, 3Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China, 4Immunology for Environment and Health, Shandong Analysis and Test Center, Shandong Academy of Science, Shandong, China, 5Molecular Immunomodulation Laboratory, Monash University, Clayton, Austria

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Immune regulation, interleukins (IL), systemic lupus erythematosus (SLE) and treatment

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Session Information

Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies

Session Type: Abstract Submissions (ACR)

Background/Purpose

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.

Methods

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.

Results

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.

Conclusion

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.


Disclosure:

J. He,
None;

X. Zhang,
None;

X. Sun,
None;

J. Guo,
None;

Y. Wei,
None;

Z. Hou,
None;

Y. Di,
None;

Z. Li,
None.

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