Evidence map›Paper›PMID 35250032›Full record

Trial reportSignal transduction and targeted therapy2022

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.

Xiaoying Zhang, Miao Miao, Ruijun Zhang, Xu Liu, Xiaozhen Zhao, Miao Shao, Tian Liu, Yuebo Jin, Jiali Chen, Huixin Liu and 14 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Signal transduction and targeted therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
9.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02467504 phase2completednot on this map

A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis

TypeinterventionalSponsorPeking University People's HospitalRan2015 to 2017Enrolled47ConditionsRheumatoid ArthritisArmshrIL-2 active, hrIL-2 placebo, MTX, Folic Acid, Loxoprofen
NCT07593365 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain

TypeinterventionalSponsorPeking University People's HospitalRan2026 to 2029Enrolled216ConditionsAromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Breast Cancer, Pain AlleviationArmstranscutaneous auricular vagus nerve stimulation, sham stimulation
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 64 citations in OpenAlex.

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  15. Low-dose IL-2 Ameliorates Experimental Autoimmune Myasthenia Gravis in Rats by Restoring the CD4-positive Helper T-cell Balance Via the JAK/STAT5 Pathway.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2026
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  16. Theranostics · 2026
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  18. EBV INFECTION OUTCOMES DETERMINED BY MONOCYTE AND TbioRxiv : the preprint server for biology · 2025
    Article
  19. [Targeting Regulatory T Cells to Remodel Peripheral Immune Tolerance: Research Advances and Future Directions].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 3 institutions in 1 country.

Xiaoying ZhangDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.ORCID 0000-0002-8130-1889
Miao MiaoDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Ruijun ZhangDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Xu LiuDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Xiaozhen ZhaoDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Miao ShaoDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Tian LiuDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yuebo JinDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Jiali ChenDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Huixin LiuDepartment of Clinical Epidemiology and Biostatistics, Peking University People's Hospital, 100044, Beijing, China.
Xia ZhangDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yun LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yunshan ZhouDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yue YangDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Ru LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Haihong YaoDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yanying LiuDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Chun LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yuhui LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Limin RenDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Yin SuDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.
Xiaolin SunDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China.ORCID 0000-0001-9709-1532
Jing HeDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China. hejing1105@126.com.ORCID 0000-0003-3904-8928
Zhanguo LiDepartment of Rheumatology and Immunology, Peking University People's Hospital, 100044, Beijing, China. li99@bjmu.edu.cn.ORCID 0000-0002-2590-6242
Peking University · CNChina Pharmaceutical University · CNWannan Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rheumatoid arthritis (RA) is an aggressive autoimmune arthritis, and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects. Low-dose interleukin-2 (Ld-IL2) is potentially a therapeutic approach to further improve the disease. This randomized, double-blind, placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active RA. Patients 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 follow-up. Three 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 break. All patients received a stable dose of methotrexate (MTX). The primary outcomes were the proportion of patients achieving the ACR20, DAS28-ESR <2.6, and the change from baseline in CDAI or SDAI at week 24. Secondary endpoints included other clinical responses and safety. The primary outcomes were achieved in the per-protocol population. The improvements from baseline in CDAI and SDAI were significantly greater across time points for the Ld-IL2 + 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 Ld-IL2. Ld-IL-2 treatment was well-tolerated in this study. These results suggested that Ld-IL2 was effective and safe in RA. ClinicalTrials.gov number: NCT02467504.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidDouble-Blind MethodDrug Therapy, CombinationHumansInterleukin-2MethotrexateTreatment OutcomeAntirheumatic AgentsInterleukin-2Methotrexate

Identifiers

PMID35250032
PMCPMC8898945
OpenAlexW4220996377

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.