Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial

• DOI: 10.1038/s41392-022-00887-2
• Publication Date: 2022-03-07T01:02:32Z
• Authors: Xiaoying Zhang; Miao Miao; Ruijun Zhang; Xu Liu; Xiaozhen Zhao; Miao Shao; Tian Liu; Yuebo Jin; Jiali Chen; Huixin Liu; Xia Zhang; Yun Li; Yunshan Zhou; Yue Yang; Ru Li; Haihong Yao; Yanying Liu; Chun Li; Yuhui Li; Limin Ren; Yin Su; Xiaolin Sun; Jing He; Zhanguo Li
• Keywords: Clinical endpoint

Abstract Rheumatoid arthritis (RA) is an aggressive autoimmune arthritis, and current therapies remain unsatisfactory due to low remission rate substantially adverse effects. Low-dose interleukin-2 (Ld-IL2) potentially a therapeutic approach further improve the disease. This randomized, double-blind, placebo-controlled trial was undertaken evaluate efficacy safety of Ld-IL2 in patients with active RA. Patients were randomly assigned (1:1) receive Ld-IL2, defined as dose 1 million IU, or placebo 12-week follow-up. Three cycles administered subcutaneously every other day for 2 weeks (a total 7 doses), followed by 2-week break. All received stable methotrexate (MTX). The primary outcomes proportion achieving ACR20, DAS28-ESR <2.6, change from baseline CDAI SDAI at week 24. Secondary endpoints included clinical responses safety. achieved per-protocol population. improvements significantly greater across time points + MTX group ( n = 17) than placebo+MTX 23) P 0.018 0.015, respectively). More ACR20 response those 12 (70.6% vs 43.5%) 24 (76.5% 56.5%) 0.014). In addition, Treg high IL-21 associated good Ld-IL2. Ld-IL-2 treatment well-tolerated this study. These results suggested that effective safe ClinicalTrials.gov number: NCT 02467504.