Crohn's disease: weekly methotrexate helped maintain remission in chronically active cases

Clinical bottom line (level 1b)

  1. Patients with chronically active Crohn's disease currently in remission who received weekly methotrexate compared with placebo were less likely to have a relapse (NNT = 4 at 10 months) .
Feagan et al: New England Journal of Medicine 2000; 342 : 1627-1632
Expires October 2003

The study

Double-blinded concealed randomised trial with intention-to-treat
Setting: 7 university hospitals, USA

76 patients (aged mean 32, 50% male) chronically active Crohn's disease, currently in remission (CDAI < 150) following weeky methotrexate 25 mg for 16 weeks

Excluded if
  • unlikely to survive more than one year
  • history of cancer
  • hypersensitivity to methotrexate
  • consumption of more than 7 alcoholic drinks per week
  • weight more than 40% above normal
  • diabetes mellitus
  • renal dysfunction (creatinine > 150 micromol/l)
  • clinically important lung disease
  • systemic infection
  • pregnant or desire to become pregnant
  • hepatic disease

    Control Group: (n = 36, 36 analysed):
    Experimental Group: (n = 40, 40 analysed):
    Patients were not allowed to use immunosuppressive agents, steroids, infliximab, aminosalicylates, antibioitics, tube feeding or parenteral nutrition
    99% followed for 10 months

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NNT
    (95% CI)
    relapse 10 months 22
    (61.1%)    		 14
    (35.0%)    		 43%
    (6% to 65%)    		 26.1%
    (4.38% to 47.8%)    		 4
    (2 to 23)

    Comments

    1. 1 patient in the methotrexate group withdrew due to nausea and vomiting. There was no clear difference in the overall rate of adverse effects between the two groups.

    Citation

    1. Feagan BG, Fedorak RN, Irvine EJ, et al: a comparison of methotrexate with placebo for the maintenance of remission in Crohn's disease. New England Journal of Medicine 2000; 342 : 1627-1632
    Contributor: Chris Ball, October 2001
    Reviewer:

    Clinical Question.
    Patient Crohn's disease in remission
    Intervention or Exposure weekly methotrexate
    Comparison placebo
    Outcome relapse