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<p>Behçet’s syndrome (BS), a chronic vasculitis, leads to recurrent oral ulcers, severely impacting quality of life. Here we report the results of a randomized, double-blind, placebo-controlled trial (NCT04065672) to evaluate the efficacy and safety of low-dose interleukin-2 (LD-IL-2) in BS patients. 60 participants with active oral ulcers are randomly assigned to receive LD-IL-2 or placebo. The primary endpoint is the oral ulcer count at week 12. The LD-IL-2 group has significantly fewer oral ulcers than the placebo group (0.69 ± 1.05 <i>vs</i>. 1.57 ± 0.90, <i>P</i> = 0.001) with greater improvements in ulcer pain, disease activity, and quality of life. No infections or severe adverse events are observed in either group. LD-IL-2 expands regulatory T (Treg) cells and decreased the ratio of effector T cell to Treg cells. Thus, LD-IL-2 therapy might be an effective and safe treatment in BS patients and is associated with the modulation of CD4 + T cell populations.</p>

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Efficacy and safety of low-dose interleukin 2 for Behçet’s syndrome: a randomized, placebo-controlled, double-blind, phase 2 clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月7日

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  • Tian Liu,
  • Wenyan Zhou,
  • Yan Zhu,
  • Weiyi Xia,
  • Jiali Chen,
  • Xian Xiao,
  • Bo Huang,
  • Ruiling Feng,
  • Hua Ye,
  • Shi Chen,
  • Xiaoying Zhang,
  • Miao Shao,
  • Chun Li,
  • Yuan Jia,
  • Miao Miao,
  • Yuebo Jin,
  • Xue Li,
  • Xia Zhang,
  • Yunshan Zhou,
  • Ru Li,
  • Xuewu Zhang,
  • Yin Su,
  • Huixin Liu,
  • Jing Li,
  • Fanlei Hu,
  • Jianping Guo,
  • Xiaolin Sun,
  • Jing He,
  • Zhanguo Li

摘要

Behçet’s syndrome (BS), a chronic vasculitis, leads to recurrent oral ulcers, severely impacting quality of life. Here we report the results of a randomized, double-blind, placebo-controlled trial (NCT04065672) to evaluate the efficacy and safety of low-dose interleukin-2 (LD-IL-2) in BS patients. 60 participants with active oral ulcers are randomly assigned to receive LD-IL-2 or placebo. The primary endpoint is the oral ulcer count at week 12. The LD-IL-2 group has significantly fewer oral ulcers than the placebo group (0.69 ± 1.05 vs. 1.57 ± 0.90, P = 0.001) with greater improvements in ulcer pain, disease activity, and quality of life. No infections or severe adverse events are observed in either group. LD-IL-2 expands regulatory T (Treg) cells and decreased the ratio of effector T cell to Treg cells. Thus, LD-IL-2 therapy might be an effective and safe treatment in BS patients and is associated with the modulation of CD4 + T cell populations.