Evidence map›Paper›PMID 35788493›Full record

Trial reportAnnals of the rheumatic diseases2022

Leflunomide versus azathioprine for maintenance therapy of lupus nephritis: a prospective, multicentre, randomised trial and long-term follow-up.

Qiong Fu, Chunmei Wu, Min Dai, Suli Wang, Jianhua Xu, Lie Dai, Zhijun Li, Lan He, Xiaochun Zhu, Lingyun Sun and 2 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01172002 (A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 4% 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.

NCT01172002 naunknown statusnot on this map

A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.

TypeinterventionalSponsorRenJi HospitalRan2010Enrolled200ConditionsNephritis, LupusArmsLeflunomide, Azathioprine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  7. Observational
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  17. Lupus Nephritis in Children: Novel Perspectives.Medicina (Kaunas, Lithuania) · 2023
    Review
  18. Article
  19. 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

12 authors at 7 institutions in 1 country.

Qiong Fu *Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China.ORCID http://orcid.org/0000-0001-5873-6422
Chunmei Wu *Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China.
Min Dai *Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China.
Suli WangDepartment of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China.
Jianhua XuDepartment of Rheumatism and Immunity, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Lie DaiDepartment of Rheumatology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangzhou, China.
Zhijun LiDepartment of Rheumatology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China.
Lan HeDepartment of Rheumatology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Xiaochun ZhuDepartment of Rheumatology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.
Lingyun SunDepartment of Rheumatology and Immunology, Affiliated Nanjing Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.ORCID http://orcid.org/0000-0002-8563-2036
Liangjing LuDepartment of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China baochunde_1678@126.com lu_liangjing@163.com.ORCID http://orcid.org/0000-0001-5393-4825
Chunde BaoDepartment of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China baochunde_1678@126.com lu_liangjing@163.com.ORCID http://orcid.org/0000-0002-0466-1872
Shanghai Jiao Tong University · CNAnhui Medical University · CNFirst Affiliated Hospital of Bengbu Medical College · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNNanjing Drum Tower Hospital · CNSun Yat-sen University · CNWenzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPrevious studies have compared mycophenolate mofetil and azathioprine as maintenance therapy for lupus nephritis (LN). Leflunomide is an immunosuppressant widely used in the treatment of rheumatoid arthritis. The aim of this investigator-initiated study was to compare the efficacy and safety of leflunomide versus azathioprine as maintenance therapy for LN.

methods270 adult patients with biopsy-confirmed active LN from 7 Chinese Rheumatology Centres were enrolled. All patients received induction therapy with 6-9 months of intravenous cyclophosphamide plus glucocorticoids. Patients who achieved complete response (CR) or partial response (PR) were randomised to receive prednisone in combination with leflunomide or azathioprine as maintenance therapy for 36 months. The primary efficacy endpoint was the time to kidney flare. Secondary outcomes included clinical parameters, extrarenal flare and adverse effects.

resultsA total of 215 patients were randomly allocated to the leflunomide group (n=108) and azathioprine group (n=107). Kidney flares were observed in 17 (15.7%) leflunomide-treated patients and 19 (17.8%) azathioprine-treated patients. Time to kidney flare did not statistically differ (leflunomide: 16 months vs azathioprine: 14 months, p=0.676). 24-hour proteinuria, serum creatinine, serum albumin, serum C3 and serum C4 improved similarly. Extrarenal flare occurred in two patients from the azathioprine group and one patient from the leflunomide group. The incidence of adverse events was similar in the 2 groups: leflunomide 56.5% and azathioprine 58.9%.

conclusionsThe efficacy and safety profile of leflunomide are non-inferior to azathioprine for maintenance therapy of LN. Leflunomide may provide a new candidate for maintenance therapy in patients with LN. TRIAL REGISTRATION NUMBER: NCT01172002.

Indexed as

AzathioprineLupus NephritisAdultCreatinineCyclophosphamideDrug Therapy, CombinationFollow-Up StudiesHumansImmunosuppressive AgentsLeflunomideMycophenolic AcidPrednisoneProspective StudiesSerum AlbuminTreatment OutcomeAzathioprineCreatinineCyclophosphamideImmunosuppressive AgentsLeflunomideMycophenolic AcidPrednisoneSerum AlbuminAntirheumatic AgentsLupus Erythematosus, SystemicLupus Nephritis

Identifiers

PMID35788493
PMCPMC9606489
OpenAlexW4283795044

What OpenQuestion holds

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LicenceCC BY-NC
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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.