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<p>Low-dose interleukin 2 (Ld-IL2) has shown therapeutic effects in autoimmune diseases, particularly systemic lupus erythematosus (SLE), yet optimal dosage has not been established in clinical trials. In this multicentre, double-blind, phase IIb trial, 152 patients with active SLE were randomised (1:1:1:1) to receive subcutaneous IL2 (0.2, 0.5, or 1.0 million IU) or placebo every other day for 12 weeks, then weekly for another 12 weeks. At week 12, SRI-4 response rates were higher in the IL2 1 M IU (69.7%), 0.5 M IU (64.7%), and 0.2 M IU (42.9%) groups than the placebo control group (23.5%). Notably, these differences persisted until week 24 (<i>P</i> &lt; 0.001). Moreover, achievement of LLDAS increased in a dose-dependent manner. Patients who received 1 M IU also showed significant reductions in PGA scores, anti-dsDNA antibody titres and prednisone dosages. Infection rates were lower in the IL2 groups compared with placebo. Ld-IL2 drove the expansion of regulatory T cells (Tregs) and altered Treg/effector T cell ratios. These findings highlight the dose-dependent efficacy of IL2 with a favourable safety profile. (Clinicaltrials.gov registration number: NCT04077684).</p>

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Low dose IL-2 therapy restores regulatory T cells in patients with systemic lupus erythematosus in a dose-dependent manner: a phase IIb trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月21日

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  • Xia Zhang,
  • Ruiling Feng,
  • Yifan Wang,
  • Wenqiang Fan,
  • Xiao Gao,
  • Miaomiao Ma,
  • Guanmin Gao,
  • Dongbin Jiang,
  • Ting Li,
  • Huifang Guo,
  • Lingyan Lei,
  • Ke Xu,
  • Yucui Li,
  • Kuanting Wang,
  • Yan Ding,
  • Wei Wei,
  • Na Zhang,
  • Wenping Pan,
  • Qingwen Wang,
  • Juan He,
  • Yueming Cai,
  • Tongjun Mao,
  • Ruijun Zhang,
  • Rong Mu,
  • Yongfu Wang,
  • Hui Wang,
  • Yuan Jia,
  • Xiaolin Sun,
  • Zhanguo Li,
  • Jing He

摘要

Low-dose interleukin 2 (Ld-IL2) has shown therapeutic effects in autoimmune diseases, particularly systemic lupus erythematosus (SLE), yet optimal dosage has not been established in clinical trials. In this multicentre, double-blind, phase IIb trial, 152 patients with active SLE were randomised (1:1:1:1) to receive subcutaneous IL2 (0.2, 0.5, or 1.0 million IU) or placebo every other day for 12 weeks, then weekly for another 12 weeks. At week 12, SRI-4 response rates were higher in the IL2 1 M IU (69.7%), 0.5 M IU (64.7%), and 0.2 M IU (42.9%) groups than the placebo control group (23.5%). Notably, these differences persisted until week 24 (P < 0.001). Moreover, achievement of LLDAS increased in a dose-dependent manner. Patients who received 1 M IU also showed significant reductions in PGA scores, anti-dsDNA antibody titres and prednisone dosages. Infection rates were lower in the IL2 groups compared with placebo. Ld-IL2 drove the expansion of regulatory T cells (Tregs) and altered Treg/effector T cell ratios. These findings highlight the dose-dependent efficacy of IL2 with a favourable safety profile. (Clinicaltrials.gov registration number: NCT04077684).