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, Jonathan A Leighton, D. C. Mays, M. G. Pike, A. R. Zinsmeister, J. J. Lipsky

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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 - 1999

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Colitis
Methotrexate
Crohn Disease
Pharmacokinetics
Steroids
Inflammatory Bowel Diseases
Remission Induction
Ulcerative Colitis

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

A randomized dose-response and pharmacokinetic study of methotrexate for refractory inflammatory Crohn's disease and unclerative colitis. / Egan, L. J.; Sandborn, W. J.; Tremaine, W. J.; Leighton, Jonathan A; Mays, D. C.; Pike, M. G.; Zinsmeister, A. R.; Lipsky, J. J.

In: Alimentary Pharmacology and Therapeutics, Vol. 13, No. 12, 1999, p. 1597-1604.

Research output: Contribution to journalArticle

Egan, L. J. ; Sandborn, W. J. ; Tremaine, W. J. ; Leighton, Jonathan A ; Mays, D. C. ; Pike, M. G. ; Zinsmeister, A. R. ; Lipsky, J. J. / A randomized dose-response and pharmacokinetic study of methotrexate for refractory inflammatory Crohn's disease and unclerative colitis. In: Alimentary Pharmacology and Therapeutics. 1999 ; Vol. 13, No. 12. pp. 1597-1604.
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AU - Sandborn, W. J.

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AU - Leighton, Jonathan A

AU - Mays, D. C.

AU - Pike, M. G.

AU - Zinsmeister, A. R.

AU - Lipsky, J. J.

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N2 - 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.

AB - 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.

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