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Area of Science:

  • Rheumatology
  • Pharmacology
  • Systematic Review

Background:

  • Methotrexate (MTX), a folic acid antagonist, is a widely used drug for neoplastic disorders and rheumatoid arthritis (RA).
  • This systematic review is an update of a previous Cochrane review from 1997, focusing on short-term RA treatment.

Purpose of the Study:

  • To evaluate the short-term benefits and harms of methotrexate (MTX) for treating rheumatoid arthritis (RA) when compared to placebo.
  • To synthesize evidence from randomized controlled trials and controlled clinical trials on MTX monotherapy in RA patients.

Main Methods:

  • Searched multiple databases (Cochrane, MEDLINE, EMBASE) from 1966 to November 2013, supplemented by reference list reviews.
  • Included randomized controlled trials and controlled clinical trials comparing MTX monotherapy against placebo in RA patients.
  • Two independent reviewers assessed study eligibility and risk of bias, extracting data for pooled analysis using various statistical methods (MDs, SMDs, RR).

Main Results:

  • Seven trials with 732 participants were included; trials generally had unclear to low risk of bias and follow-up of 12-52 weeks.
  • MTX monotherapy demonstrated statistically significant improvements in ACR 50 response rate (NNT 7), physical function (NNT 4), and SF-36 physical component (NNT 9) compared to placebo.
  • Radiographic progression rates were significantly lower with MTX (NNT 13), but no significant difference was found in SF-36 mental component or remission rates.

Conclusions:

  • Methotrexate (5-25 mg weekly) offers substantial short-term clinical benefits for RA patients compared to placebo.
  • Despite benefits, MTX use was associated with a 16% discontinuation rate due to adverse events.
  • Evidence quality was mainly moderate to high, supporting MTX as an effective short-term RA treatment.