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Mycophenolate mofetil for relapsing-remitting multiple sclerosis

  1. Yousheng Xiao1,
  2. Jianyi Huang1,
  3. Hongye Luo2,
  4. Jin Wang1,*

Editorial Group: Cochrane Multiple Sclerosis and Rare Diseases of the CNS Group

Published Online: 7 FEB 2014

Assessed as up-to-date: 20 JAN 2013

DOI: 10.1002/14651858.CD010242.pub2


How to Cite

Xiao Y, Huang J, Luo H, Wang J. Mycophenolate mofetil for relapsing-remitting multiple sclerosis. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD010242. DOI: 10.1002/14651858.CD010242.pub2.

Author Information

  1. 1

    The First Affiliated Hospital, Guangxi Medical University, Department of Neurology, Nanning, Guangxi, China

  2. 2

    Guangxi Medical University, Department of Epidemiology & Statistics, Nanning, Guangxi, China

*Jin Wang, Department of Neurology, The First Affiliated Hospital, Guangxi Medical University, No. 22, Shuang Yong Lu, Nanning, Guangxi, 530021, China. wangjin72@126.com.

Publication History

  1. Publication Status: New
  2. Published Online: 7 FEB 2014

SEARCH

 
Characteristics of included studies [ordered by study ID]
Etemadifar 2011

MethodsRandomized, blinded, placebo-controlled design was mentioned in the report. Random list generated was using a random number table. We could obtain no additional information through correspondence with the study authors


ParticipantsSetting: Isfahan MS Society, Iran

N = 26; MMF group = 13, F/M = 8/5, mean age = 31.3 ± 8.1 years, disease duration = 5.0 ± 4.5 months; placebo group = 13, F/M = 9/4, mean age = 29.6 ± 6.7 years, disease duration = 3.6 ± 3.2 months

Inclusion criteria: clinically definite RRMS, age 18 to 55 years, disease duration < two years, baseline EDSS < 6.0

Exclusion criteria: use of immunomodulatory or immunosuppressive drugs, relapse within two months, pregnant, abnormal blood tests, other major medical illnesses (eg, cancer, significant gastrointestinal disease, immunodeficiency, other autoimmune diseases)
Characteristics of participants at baseline: similar


InterventionsIntervention group: IFN-β-1a and oral MMF started at 500 mg daily for one week, then increased by 500 mg per week until a target dose of 2000 mg daily; after this, dose was continued for 12 months
Control group: IFN-β-1a and placebo; same dose and administration method as in the intervention group for 12 months


Outcomes
  1. Numbers of new T2- and new Gd-enhanced lesions on MRI evaluation after 12-month follow-up
  2. Relapse rate
  3. Changes in EDSS score. EDSS assessment was performed at baseline and then after one year of therapy
  4. Adverse effects


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number table generated by software

Allocation concealment (selection bias)Unclear riskNot described

Blinding of participants and personnel (performance bias)
All outcomes
High riskTreating personnel were not blinded. No description on whether MMF and placebo with identical appearance and packaging were provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessors were blinded. Blinding is reported only for "Two radiologists, blinded to the treatment arms, [who] were responsible for MRI evaluations" but is not reported for assessors of clinical outcome

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants completed the study

Selective reporting (reporting bias)High riskAll specified primary and secondary outcomes were reported. The interval of confirmation to assess sustained disability progression was not reported. Poor reporting of adverse effects was another major limitation of the study

Other biasHigh riskSample size calculation was not clearly reported. Small sample size led to an inadequately powered trial

No description of the source of MMF and placebo (eg, sponsored by a pharmaceutical company or other)

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Frohman 2004Retrospective review

Frohman 2010Six-month follow-up study without our specified 12-month follow-up outcome measures

NCT00618527Experimental study that was "completed" in May 2012 (as reported on clinicaltrials.gov). Outcome measures did not fulfil our inclusion criteria

Remington 2010Study authors enrolled both participants with early RRMS and those with clinically isolated syndrome (CIS). Details of RRMS and CIS were not available

Vermersch 2007Case series study of 30 participants with RRMS treated with MMF in combination with IFN without a control group

 
Characteristics of studies awaiting assessment [ordered by study ID]
NCT00324506

MethodsRandomized, open-label, parallel-group multicenter study to determine the safety/efficacy of mycophenolate mofetil in mono and combination therapy with interferon-β-1a in patients with relapsing remitting multiple sclerosis

ParticipantsSixty participants (20 participants at each recruiting center) with RRMS

InterventionsMycophenolate mofetil in mono and combination therapy with interferon-β-1a

OutcomesPrimary objective of this safety/mechanistic study is to determine the safety and tolerability of oral mycophenolate when compared with weekly intramuscular interferon-β-1a in RRMS. Safety will be assessed by virtue of changes on MRI. Secondary outcome measures included
changes in exacerbation frequency, incidence of exacerbation in treated groups, changes in level of sustained disability, and changes in quality of life measures and in assessment of fatigue

NotesPrimary completion date: June 2009 (final data collection date for primary outcome measure). This study has been completed. Last updated: June 17, 2013