Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

Summary

The management of active systemic lupus erythematosus (SLE) is challenging due to the heterogeneous nature of the disease and lack of specific treatment. Current treatment regimens mainly rely on corticosteroids and immunosuppressive agents which are associated with substantial adverse effects including various infections. Therefore, there is an unmet need for new therapies with better efficacy and less adverse effects. Defective IL-2 production contributes to the unbalanced immune system in SLE. Previous short term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active SLE. It was suggested that low-dose IL-2 treatment promoted regulatory T cells (Treg) and inhibited T helper 17 cells (Th17) and follicular helper T cells (Tfh). The immunological rebalancing was associated with the induction of remission in SLE patients. To establish that which low doses of IL-2 would be more efficacious and safe in active SLE, we carried out a multi-center, randomized, double-blind, placebo-controlled trial of three doses of IL2 (0.2 MIU, 0.5 MIU or 1 MIU) versus placebo.

Timeline

Start

2019-09-10

Primary completion

2024-03-07

Completion

2024-08-30

Publications

• Zhang X, Feng R, Wang Y, Fan W, Gao X, Ma M, Gao G, Jiang D, Li T, Guo H, Lei L, Xu K, Li Y, Wang K, Ding Y, Wei W, Zhang N, Pan W, Wang Q, He J, Cai Y, Mao T, Zhang R, Mu R, Wang Y, Wang H, Jia Y, Sun X, Li Z, He J. Low dose IL-2 therapy restores regulatory T cells in patients with systemic lupus erythematosus in a dose-dependent manner: a phase IIb trial. Nat Commun. 2026 Apr 21;17(1):5493. doi: 10.1038/s41467-026-72245-7.

Drugs

Indications