Evidence map›Paper›PMID 31781682›Full record

Trial reportJournal of immunology research2019

Low-Dose Sirolimus Immunoregulation Therapy in Patients with Active Rheumatoid Arthritis: A 24-Week Follow-Up of the Randomized, Open-Label, Parallel-Controlled Trial.

Hong-Yan Wen, Jia Wang, Sheng-Xiao Zhang, Jing Luo, Xiang-Cong Zhao, Chen Zhang, Cai-Hong Wang, Fang-Yuan Hu, Xiao-Juan Zheng, Ting Cheng and 10 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunology research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

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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

20 authors at 4 institutions in 2 countries.

Hong-Yan WenDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0002-0007-5411
Jia WangDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0003-2181-0750
Sheng-Xiao ZhangDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0003-1341-7588
Jing LuoDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0002-1242-0286
Xiang-Cong ZhaoDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Chen ZhangDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Cai-Hong WangDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0003-0817-7946
Fang-Yuan HuDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Xiao-Juan ZhengDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Ting ChengDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Hong-Qing NiuDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Guang-Ying LiuDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Wen-Xian YangDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Na-Na YuDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Jin-Li RuDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Qi-Xiang ChenNCPC New Preparation Branch Factory, North China Pharmaceutical Co., Ltd., 115 Hainan Road, Shijiazhuang, Hebei, China.
Xue-Chun LuDepartment of Hematology, PLA General Hospital, Beijing, China.
Pei-Feng HeDepartment of Medical Information Management, Shanxi Medical University, Taiyuan, Shanxi, China.
Chong GaoDepartment of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Xiao-Feng LiDepartment of Rheumatology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.ORCID https://orcid.org/0000-0002-8899-1886
Shanxi Medical University · CNBrigham and Women's Hospital · USChina North Industries Group Corporation (China) · CNChinese PLA General Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe have reported previously the insufficient absolute number or functional defects of regulatory T cells (Tregs) in patients with rheumatoid arthritis (RA), challenging conventional unspecific immunosuppressive therapy. Sirolimus, a mTOR inhibitor, is reported to allow growth of functional Tregs; here, we investigated the efficacy of low-dose sirolimus combined with conventional immunosuppressants (sirolimus immunoregulation therapy) for RA treatment with lower side effects and better tolerance.

methodsIn this nonblinded and parallel-group trial, we randomly assigned 62 patients to receive conventional glucocorticoids and immunosuppressants with or without sirolimus at a dosage of 0.5 mg on alternate days for 24 weeks in a 2 : 1 ratio. The demographic features, clinical manifestations, and laboratory indicators including peripheral blood lymphocyte subgroups and CD4

resultsFinally, 37 patients in the sirolimus group and 18 in the conventional treated group completed the 6-month study. By 24 weeks, the patients with sirolimus experienced significant reduction in disease activity indicators including DAS28, ESR, and the number of tender joints and swollen joints (

conclusionsLow-dose sirolimus immunoregulatory therapy selectively upregulated Tregs and partly replaced the usage of immunosuppressants to control disease activity without overtreatment and evaluable side effect. Further study is required using a large sample of RA patients treated with sirolimus for a longer period. This trial is registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=17245).

Indexed as

AdultArthritis, RheumatoidBiomarkersFemaleFollow-Up StudiesHumansImmunomodulationImmunosuppressive AgentsMaleMiddle AgedSeverity of Illness IndexSirolimusT-Lymphocytes, RegulatoryT-Lymphocyte SubsetsTreatment OutcomeBiomarkersImmunosuppressive AgentsSirolimus

Identifiers

PMID31781682
PMCPMC6874993
OpenAlexW2982780745

What OpenQuestion holds

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Registered trials

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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.