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 language | English (US) |
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Pages (from-to) | 1597-1604 |
Number of pages | 8 |
Journal | Alimentary Pharmacology and Therapeutics |
Volume | 13 |
Issue number | 12 |
DOIs | |
State | Published - 1999 |
ASJC Scopus subject areas
- Hepatology
- Gastroenterology
- Pharmacology (medical)