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Methotrexate Induces Clinical and Histologic Remission in Patients with Refractory Inflammatory Bowel Disease

Richard A. Kozarek, MD; David J. Patterson, MD; Martin D. Gelfand, MD; V. Alin Botoman, MD; Terrence J. Ball, MD; and Kenneth R. Wilske, MD
[+] Article, Author, and Disclosure Information

Requests for Reprints: Richard A. Kozarek, MD, Section of Therapeutic Endoscopy, Virginia Mason Clinic, P.O. Box 900, Seattle, WA 98111.

Current Author Addresses: Drs. Kozarek, Patterson, Gelfand, Botoman, Ball, and Wilske: Virginia Mason Clinic, P.O. Box 900, Seattle, WA 98111.

© 1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;110(5):353-356. doi:10.7326/0003-4819-110-5-353
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Study Objective: To determine whether methotrexate has anti-inflammatory activity in refractory inflammatory bowel disease.

Design: Nonrandomized, open-label, preliminary trial of methotrexate along with standard medications for 12 weeks.

Setting: Referral-based gastroenterology practice.

Patients: Twenty-one patients with refractory inflammatory bowel disease (14, Crohn disease; 7, chronic ulcerative colitis); 17 taking variable doses of corticosteroids and 14 on sulfasalazine or metronidazole. Of the 21 patients, 10 had previously failed azathioprine or 6-mercaptopurine trials.

Interventions: Sulfasalazine and metronidazole were continued and prednisone dose was tapered according to clinical response. Methotrexate was given as a 25-mg intramuscular injection weekly for 12 weeks, then switched to a tapering oral dose if a clinical and objective improvement was noted.

Measurements and Main Results: Sixteen of twenty-one patients (11 of 14 patients with Crohn disease, 5 of 7 patients with chronic ulcerative colitis) had an objective response as measured by disease activity indices (modified Crohn's Disease Activity Index, 13.3 to 5.4 [P = 0.0001], Ulcerative Colitis Activity Index, 13.3 to 6.3 [P = 0.007]). Prednisone dosage decreased from 21.4 mg ±5.6 (SEM) to 5.5 mg ±2.0; P = 0.006 and 38.6 mg ±6.35 to 12.9mg ±3.4; P = 0.01, respectively. Five patients with Crohn colitis had colonoscopic healing and 4 had normal histology at 12 weeks. In contrast, none of the 7 patients with ulcerative colitis had normal flexible sigmoidoscopies, despite histologic improvement in 5. Side effects included mild rises in transaminase levels in 2 patients, transient leukopenia in 1, self-limited diarrhea and nausea in 2 patients, and 1 case each of brittle nails and atypical pneumonitis.

Conclusions: Although this pilot study is encouraging, further work is needed before methotrexate can be recommended for inflammatory bowel disease.





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