Evidence map›Paper›PMID 42399917›Full record

Trial reportBMC medicine2026

Efficacy of leflunomide in active Takayasu arteritis: a randomized double-blind placebo-controlled trial : Takayasu arteritis clinical trial in China (TACTIC).

Ying Sun, Xiufang Kong, Xiaomin Dai, Rui Wu, Lili Pan, Lijun Wu, Xiaoxiang Chen, Pingting Yang, Huiyong Chen, Lili Ma and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02981979 (Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combined With Basic Prednisone Therapy in Patients With Active Takayasu Arteritis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT02981979 nacompletednot on this map

Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combined With Basic Prednisone Therapy in Patients With Active Takayasu Arteritis: a Randomized Double-blind Controlled Clinical Trial

TypeinterventionalSponsorJiang lindiRan2016 to 2022Enrolled116ConditionsTakayasu ArteritisArmsLeflunomide(LEF), Prednisone Acetate Tablets, Placebos
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Ying SunDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Xiufang KongDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Xiaomin DaiDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Rui WuDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Nanchang University, Nanchang, P. R. China.
Lili PanDepartment of Rheumatology and Immunology, Capital Medical University Affiliated Anzhen Hospital, Beijing, P. R. China.
Lijun WuDepartment of Rheumatology and Immunology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, P. R. China.
Xiaoxiang ChenDepartment of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, P. R. China.
Pingting YangDepartment of Rheumatology and Immunology, The First Hospital of China Medical University, Shenyang, P. R. China.
Huiyong ChenDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Lili MaDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Xuejuan JinDepartment of Cardiology, Institutes of Biomedical Sciences, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Wei ZhangBiomedical Information & Statistics Center, School of Public Health, Fudan University, Shanghai, P.R. China.
Lindi JiangDepartment of Rheumatology and Immunology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China. jiang.lindi@zs-hospital.sh.cn.

Funding

Zhongshan Hospital 2016ZSL-06
6 · The paper itself

Abstract

backgroundLeflunomide (LEF) shows promising effect in Takayasu arteritis (TAK), but evidence from randomized controlled trials is lacking. This study aims to investigate the efficacy and safety of LEF versus placebo combined with prednisone for the treatment of TAK.

methodsThis is a multicenter, randomized, double-blind, placebo-controlled trial at six sites across China, conducting from December 22, 2016, to November 4, 2022. A total of 116 eligible patients were recruited and randomized 1:1 to receive LEF (20 mg/d, p.o.) or matched placebo for 24 weeks, with all patients having initial prednisone of 0.6 mg/kg/d and following a taper starting at week 4. By week 24, patients in the LEF group who did not achieve clinical remission discontinued the study; all other patients (both LEF and placebo groups) received LEF (20 mg/d) from week 25 to week 52. The primary outcome was clinical remission at week 24. Secondary outcomes were time-to-clinical remission, mean prednisone dose at week 24, clinical remission in those who switched to LEF from week 25, disease recurrence and time-to-recurrence, imaging changes, and safety.

resultsFifty-four and 57, 45 and 48 patients were included in LEF and placebo group of modified intention-to-treat (mITT) and per-protocol set (PPS). In mITT set, clinical remission was achieved in 44/54 (81.5%) LEF- and 45/57 (78.9%) placebo-treated patients (risk difference: 2.6, 95%CI: -12.5, 17.2) at week 24. The same trend was observed in the sensitivity analyses. Post hoc analyses indicated greater risk differences (LEF minus placebo) in the female subgroup, ≤ 40 years subgroup, refractory subgroup, systemic symptoms subgroup, imaging type II subgroup and in those achieving the composite endpoint of both clinical remission and stable/improved imaging. At week 24, LEF group had a lower mean prednisone dose (mean difference: -2.1, [-4.3, 0.1] mg/d). Adverse events were observed in 13 (24.5%) LEF- and 22 (39.3%) placebo-treated patients. Serious adverse events were reported in six LEF- and four placebo-treated patients. One death was reported in placebo group.

conclusionsAlthough the primary endpoint was not met, our results still provide evidence supporting LEF as a potential alternative treatment option for TAK.

trial registrationClinicalTrials.gov identifier NCT02981979.

Indexed as

Immunosuppressive AgentsLeflunomideTakayasu ArteritisAdolescentAdultChinaDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPrednisoneRemission InductionTreatment OutcomeYoung AdultImmunosuppressive AgentsLeflunomidePrednisoneDouble-blindLeflunomidePlaceboRandomizedTakayasu arteritis

Identifiers

PMID42399917
PMCPMC13644140

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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.