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

作     者：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 

作者机构：Department of Rheumatology and ImmunologyPeking University People’s Hospital100044 BeijingChina Department of Rheumatology and ImmunologyThe First Affiliated Hospital of Wannan Medical College241000 WuhuAnhuiChina Department of Clinical Epidemiology and BiostatisticsPeking University People’s Hospital100044 BeijingChina Beijing Key Laboratory for Rheumatism Mechanism and Immune Diagnosis(BZ0135)BeijingChina Peking-Tsinghua Center for Life SciencesBeijingChina State Key Laboratory of Natural and Biomimetic DrugsSchool of Pharmaceutical SciencesPeking UniversityBeijingChina 

出 版 物：《Signal Transduction and Targeted Therapy》 (信号转导与靶向治疗（英文）)

年 卷 期：2022年第7卷第4期

页      面：1194-1201页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：National Natural Science Foundation of China(U1903210,31530020,81701598,31570880,81471601,81801617) Beijing SciTech Program(Z171100000417007,Z191100006619114) Macao Science and Technology Fund(0094/2018/A3) 

主　　题：patients placebo methotrexate 

摘      要：Rheumatoid arthritis(RA)is an aggressive autoimmune arthritis,and current therapies remain unsatisfactory due to low remission rate and substantially adverse ***-dose interleukin-2(Ld-IL2)is potentially a therapeutic approach to further improve the *** randomized,double-blind,placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active *** were randomly assigned(1:1)to receive Ld-IL2,defined as a dose of 1 million IU,or placebo in a 12-week trial with a 12-week *** cycles of Ld-IL2 or placebo were administered subcutaneously every other day for 2 weeks(a total of 7 doses),followed by a 2-week *** patients received a stable dose of methotrexate(MTX).The primary outcomes were the proportion of patients achieving the ACR20,DAS28-ESR2.6,and the change from baseline in CDAI or SDAI at week *** endpoints included other clinical responses and *** primary outcomes were achieved in the perprotocol *** improvements from baseline in CDAI and SDAI were significantly greater across time points for the LdIL2+MTX group(n=17)than for the placebo+MTX group(n=23)(P=0.018 and P=0.015,respectively).More patients achieved ACR20 response in the Ld-IL2+MTX group than those in the placebo+MTX group at week 12(70.6%vs 43.5%)and at week 24(76.5%vs 56.5%)(P=0.014).In addition,low Treg and high IL-21 were associated with good responses to ***-IL-2 treatment was well-tolerated in this *** results suggested that Ld-IL2 was effective and safe in *** number:NCT 02467504.