Methotrexate for maintenance of remission in Crohn's disease

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#administration-oral #crohn-disease #drug-administration-schedule #humans #immunosuppressive-agents

Methotrexate for maintenance of remission in Crohn's disease

Patel et al., 2009 | Cochrane Database Syst Rev | Systematic Review

Citation

Patel Vishal, Macdonald John K, ... Chande Nilesh. Methotrexate for maintenance of remission in Crohn's disease. Cochrane Database Syst Rev. 2009-Oct-07(4):CD006884. doi:10.1002/14651858.CD006884.pub2

Abstract

BACKGROUND: Safe and effective long-term treatments that reduce the need for corticosteroids are needed for Crohn's disease. Although purine antimetabolites are moderately effective for maintenance of remission patients often relapse despite treatment with these agents. Methotrexate may provide a safe and effective alternative to more expensive maintenance treatment with TNF-alpha antagonists. OBJECTIVES: To conduct a systematic review of randomized trials examining the efficacy and safety of methotrexate for maintenance of remission in Crohn's disease. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2009, PUBMED (1966 to April 2009), EMBASE (1984 to April 2009), DDW abstracts (1980 to 2008) and the Cochrane IBD/FBD Specialized Trials Register were searched. Study references and review papers were also searched for additional trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared methotrexate to placebo or any other active intervention for maintenance of remission in Crohn's disease were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of methodological quality of included studies were independently performed by each author. The main outcome measure was the proportion of patients maintaining clinical remission as defined by the studies and expressed as a percentage of the total number of patients randomized (intention to treat analysis). Pooled odds ratios and 95% confidence intervals were calculated for dichotomous outcomes. MAIN RESULTS: Three studies were included in the review. A pooled analysis (n = 98) including one high quality trail (n = 76) showed that intramuscular methotrexate (15 mg/week) was significantly more effective than placebo for maintenance of remission in Crohn's disease (OR 3.11; 95% CI 1.31 to 7.41; P = 0.01). The number needed to treat to prevent one relapse was 4. A pooled analysis of two small studies (n = 50) showed no difference between methotrexate and 6-MP for maintenance of remission (OR 2.63; 95% CI 0.74 to 9.37; P = 0.14). Adverse events were generally mild in nature and resolved upon discontinuation or with folic acid supplementation. Common adverse events included nausea and vomiting, symptoms of a cold, abdominal pain, headache, joint pain or arthralgia, and fatigue. AUTHORS' CONCLUSIONS: Intramuscular methotrexate at a dose of 15 mg/week is safe and effective for maintenance of remission in Crohn's disease. Oral methotrexate (12.5 to 15 mg/week) does not appear to be effective for maintenance of remission in Crohn's disease.

Key Findings

Three studies were included in the review. A pooled analysis (n = 98) including one high quality trail (n = 76) showed that intramuscular methotrexate (15 mg/week) was significantly more effective than placebo for maintenance of remission in Crohn's disease (OR 3.11; 95% CI 1.31 to 7.41; P = 0.01). The number needed to treat to prevent one relapse was 4. A pooled analysis of two small studies (n = 50) showed no difference between methotrexate and 6-MP for maintenance of remission (OR 2.63; 95% C

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 98
Age Range See abstract
Condition See abstract

MeSH Terms

  • Administration, Oral
  • Crohn Disease
  • Drug Administration Schedule
  • Humans
  • Immunosuppressive Agents
  • Injections, Intramuscular
  • Methotrexate
  • Randomized Controlled Trials as Topic
  • Remission Induction

Evidence Classification

  • Level: Systematic Review
  • Publication Types: Journal Article, Systematic Review
  • Vertical: folate

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09