A randomized dose-response and pharmacokinetic study of methotrexate for refractory inflammatory Crohn's disease and unclerative colitis

L. J. Egan, W. J. Sandborn, W. J. Tremaine, J. A. Leighton, D. C. Mays, M. G. Pike, A. R. Zinsmeister, J. J. Lipsky

Research output: Contribution to journalArticle

67 Scopus citations

Abstract

Background and aims: The optimum initial dose of methotrexate for steroid-requiring inflammatory bowel disease is not known. Aim: To compare directly the efficacy and toxicity of methotrexate 15 and 25 mg/week, and to explore the value of methotrexate blood levels as predictors of outcome. Methods: A 16-week randomized single-blind comparison of subcutaneous methotrexate 15 or 25 mg/week was performed in 32 patients with steroid-requiring Crohn's disease or ulcerative colitis. Patients who did not respond to methotrexate 15 mg/week were further studied for an additional 16 weeks on methotrexate 25 mg/week. Blood was drawn every 2 weeks for methotrexate levels. Results: After 16 weeks, 17% of patients in each group achieved remission; 39% of patients randomized to 15 mg/week and 33% of patients randomized to 25 mg/week improved (P = N.S.). Clinical status improved in four out of 11 patients after methotrexate dose escalation from 15 to 25 mg/week. Toxicity was not different between the treatment groups. Methotrexate blood levels did not predict efficacy or toxicity. Conclusions: For induction of remission in steroid-requiring inflammatory bowel disease, subcutaneous methotrexate at initial doses of 15 and 25 mg/week are equally efficacious. At these doses, response is not associated with blood methotrexate concentrations.

Original languageEnglish (US)
Pages (from-to)1597-1604
Number of pages8
JournalAlimentary Pharmacology and Therapeutics
Volume13
Issue number12
DOIs
StatePublished - Dec 1 1999

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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