Evidence map›Paper›PMID 27428186›Full record

Trial reportMedicine2016

High remission and low relapse with prolonged intensive DMARD therapy in rheumatoid arthritis (PRINT): A multicenter randomized clinical trial.

Ru Li, Jin-Xia Zhao, Yin Su, Jing He, Li-Na Chen, Fei Gu, Cheng Zhao, Xue-Rong Deng, Wei Zhou, Yan-Jie Hao and 15 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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  10. Clinical Practice Guideline forFrontiers in pharmacology · 2020
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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

25 authors at 14 institutions in 3 countries.

Ru LiDepartment of Rheumatology and Immunology, Peking University People's Hospital Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing Department of Clinical Immunology, Fourth Military Medical University Xijing Hospital, Xi'an Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing Department of Rheumatology and Immunology, Fudan University Huashan Hospital, Shanghai Department of Rheumatology and Immunology, Shandong University Qilu Hospital, Jinan Department of Rheumatology and Immunology, Sichuan University West China Hospital, Chengdu Department of Rheumatology and Immunology, Third Military Medical University Southwest Hospital, Chongqing, China The Rebecca MacDonald Centre for Arthritis and Autoimmune Diseases, Mount Sinai Hospital, University of Toronto, Toronto, Canada Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Jin-Xia Zhao
Yin Su
Jing He
Li-Na Chen
Fei Gu
Cheng Zhao
Xue-Rong Deng
Wei Zhou
Yan-Jie Hao
Yu Xue
Hua-Xiang Liu
Yi Zhao
Qing-Hua Zou
Xiang-Yuan Liu
Ping Zhu
Ling-Yun Sun
Zhuo-Li Zhang
He-Jian Zou
Xing-Fu Li
Yi Liu
Yong-Fei Fang
Edward Keystone
Iain B McInnes
Zhan-Guo Li
Peking University First Hospital · CNNanjing Drum Tower Hospital · CNPeking University · CNArmy Medical University · CNFudan University · CNPeking University People's Hospital · CNQilu Hospital of Shandong University · CNAir Force Medical University · CNMount Sinai Hospital · CAPeking University Third Hospital · CNSichuan University · CNUniversity of Glasgow · GBWest China Hospital of Sichuan University · CNXijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine whether prolonged intensive disease-modifying antirheumatic drug (DMARD) treatment (PRINT) leads to high remission and low relapse rates in patients with severe rheumatoid arthritis (RA).

methodsIn this multicenter, randomized and parallel treatment trial, 346 patients with active RA (disease activity score (28 joints) [DAS28] (erythrocyte sedimentation rate [ESR]) > 5.1) were enrolled from 9 centers. In phase 1, patients received intensive treatment with methotrexate, leflunomide, and hydroxychloroquine, up to 36 weeks, until remission (DAS28 ≤ 2.6) or a low disease activity (2.6 < DAS28 ≤ 3.2) was achieved. In phase 2, patients achieving remission or low disease activity were followed up with randomization to 1 of 2 step-down protocols: leflunomide plus hydroxychloroquine combination or leflunomide monotherapy. The primary endpoints were good European League Against Rheumatism (EULAR) response (DAS28 (ESR) < 3.2 and a decrease of DAS28 by at least 1.2) during the intensive treatment and the disease state retention rate during step-down maintenance treatment. Predictors of a good EULAR response in the intensive treatment period and disease flare in the maintenance period were sought.

resultsA good EULAR response was achieved in 18.7%, 36.9%, and 54.1% of patients at 12, 24, and 36 weeks, respectively. By 36 weeks, 75.4% of patients achieved good and moderate EULAR responses. Compared with those achieving low disease activity and a high health assessment questionnaire (HAQ > 0.5), patients achieving remission (DAS28 ≤ 2.6) and low HAQ (≤ 0.5) had a significantly higher retention rate when tapering the DMARDs treatment (P = 0.046 and P = 0.01, respectively). There was no advantage on tapering to combination rather than monotherapy.

conclusionsRemission was achieved in a proportion of patients with RA receiving prolonged intensive DMARD therapy. Low disease activity at the start of disease taper leads to less subsequent flares. Leflunomide is a good maintenance treatment as single treatment.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidBlood SedimentationChinaDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMaleMiddle AgedRecurrenceTreatment OutcomeAntirheumatic AgentsImmunosuppressive Agents

Identifiers

PMID27428186
PMCPMC4956780
OpenAlexW2461676344

What OpenQuestion holds

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LicenceCC BY-ND
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Registered trials

None linked

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.