Evidence map›Paper›PMID 26835147›Full record

ArticleLupus science & medicine2016

A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience.

Sirirat Anutrakulchai, Thanachai Panaput, Jeerapat Wongchinsri, Somchai Chaishayanon, Bancha Satirapoj, Opas Traitanon, Warabhorn Pima, Chutima Rukrung, Bandit Thinkhamrop, Yingyos Avihingsanon

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Lupus science & medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01015456 (The Clinical Efficacy and Economic Evaluation of EC-MPS), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT01015456 phase3terminatednot on this map

The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis

TypeinterventionalSponsorChulalongkorn UniversityRan2010 to 2013Enrolled59ConditionsLupus NephritisArmsmycophenolate sodium, cyclophosphamide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Immunosuppressive treatment for proliferative lupus nephritis.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. 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

10 authors at 6 institutions in 1 country.

Sirirat AnutrakulchaiDepartment of Medicine , Khon Kaen University , Khon Kaen , Thailand.
Thanachai PanaputDepartment of Medicine , Khon Kaen Regional Hospital , Khon Kaen , Thailand.
Jeerapat WongchinsriDepartment of Medicine , Nopparat Rajathani Hospital , Bangkok , Thailand.
Somchai ChaishayanonDepartment of Medicine , Nopparat Rajathani Hospital , Bangkok , Thailand.
Bancha SatirapojDepartment of Medicine , Phramongkutklao Hospital , Bangkok , Thailand.
Opas TraitanonDepartment of Medicine , Thammasart University , Pathumthani , Thailand.
Warabhorn PimaMedical University Research Network of the Consortium of Thai Medical Schools (MedResNet) , Thailand.
Chutima RukrungChulalongkorn Clinical Research Center (ChulaCRC) , Chulalongkorn University , Bangkok , Thailand.
Bandit ThinkhamropDepartment of Biostatistics and Demography, Faculty of Public Health , Khon Kaen University , Khon Kaen , Thailand.
Yingyos AvihingsanonDepartment of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok,Thailand; Center of Excellence in Immunology and Immune-mediated Diseases, Chulalongkorn University, Bangkok, Thailand.
Khon Kaen University · THChulalongkorn University · THNopparat Rajathanee Hospital · THPhramongkutklao Hospital · THThai Health Promotion Foundation · THThammasat University · TH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe optimal treatment of relapse or resistant lupus nephritis (LN) is still unclear. Mycophenolate might be an alternative therapy to avoid toxicities of cyclophosphamide (CYC). This study was aimed to compare enteric-coated mycophenolate sodium (EC-MPS) versus intravenous CYC as an induction therapy.

methodsThe study was a 12-month period of multicentre, open-labelled randomised controlled trial. Fifty-nine patients who had relapsed (36%) or who were resistant to previous CYC treatment (64%) and all who were biopsy-proven class III/IV, were randomised into CYC (n=32) and EC-MPS groups (n=27). The CYC group received intravenous CYC 0.5-1 g/m(2) monthly and the EC-MPS group was treated with EC-MPS 1440 mg/day for first 6 months. After induction therapy, both groups received EC-MPS 720 mg/day until the end of study at 12 months.

resultsThe study was prematurely terminated due to high rate of serious adverse events in CYC arm. Death and serious infections were observed more in the CYC group (15.6% in CYC and 3.5% in EC-MPS; p=0.04). The early discontinuation rates, mainly from serious infections, were significantly higher in CYC group (percentage differences of 16.9; 95% CI 1.3 to 32.4). At the 12th month, both arms were comparable in terms of complete and partial remission rates (68% CYC and 71% EC-MPS) and times to remission (96 days CYC and 97 days EC-MPS). Composites of unfavourable outcomes (death, doubling of serum creatinine, non-remission and intolerance to treatment) were 46.9% and 37% in CYC and EC-MPS (risk difference=9.84; p=0.44).

conclusionsEC-MPS may have comparable efficacy, but was better tolerated than CYC. EC-MPS should be an alternative choice of treatment for difficult-to-treat LN, particularly in CYC-experienced LN patients. Due to an early termination of the study, further clinical implementation could be cautiously used. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov ID#NCT01015456.

Indexed as

CyclophosphamideInfectionsLupus NephritisTreatment

Identifiers

PMID26835147
PMCPMC4716419
OpenAlexW2235298918

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.