Mucosal healing with methotrexate in Crohn's disease: a prospective comparative study with azathioprine and infliximab

Aliment Pharmacol Ther. 2011 Mar;33(6):714-21. doi: 10.1111/j.1365-2036.2010.04569.x. Epub 2011 Jan 16.


Background: Mucosal healing has become a new therapeutic goal in Crohn's disease and can be achieved with azathioprine (AZA) or biologics. Methotrexate (MTX) is an effective drug for both the induction and maintenance of remission in Crohn's disease. However, mucosal healing with MTX has been poorly investigated.

Aim: To assess the mucosal healing rate in patients with Crohn's disease with clinical response to MTX as compared with AZA or infliximab (IFX).

Methods: From October 2007 to May 2009, consecutive patients with Crohn's disease were prospectively enrolled into a single-centre study when they met the following criteria: previous identification of mucosal ulcerations with ileo-colonoscopy, clinical remission within at least 3 months with MTX, AZA or IFX monotherapy, usual indication for colonoscopy in Crohn's disease (dysplasia/cancer screening, suspected stenosis) excluding assessment for mucosal healing. Mucosal healing was defined as absence of mucosal ulceration in all segments.

Results: Fifty-one patients with Crohn's disease (38 female; median age: 42 years) were included: 18 receiving MTX, 18 AZA and 15 IFX. Mucosal healing was achieved in 2/18 (11%) with MTX, in 9/18 (50%) with AZA (P =0.011 vs. MTX) and in 9/15 (60%) with IFX (P=0.008 vs. MTX).

Conclusion: In patients with Crohn's disease in sustained clinical remission, mucosal healing is less frequently achieved with MTX as compared with AZA or IFX.

Publication types

  • Comparative Study
  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / therapeutic use
  • Azathioprine / therapeutic use
  • Colonoscopy
  • Crohn Disease / drug therapy*
  • Crohn Disease / physiopathology
  • Epidemiologic Methods
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Infliximab
  • Intestinal Mucosa / physiopathology
  • Male
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Treatment Outcome
  • Wound Healing / drug effects
  • Young Adult


  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Immunosuppressive Agents
  • Infliximab
  • Azathioprine
  • Methotrexate