Aim: To evaluate the clinical response to methotrexate (MTX) in a cohort of pediatric Crohn’s disease patients refractory to conventional therapy (5-ASA; prednisone, 6-MP). Methods: Prospective study (9/95-5/99) included 10 patients (8F, 2M) aged <21 years. Crohn’s disease involved the colon in all 10, and was restricted to the colon in 3 patients. 4/10 cases were corticoresistant and the 6 others were corticodependant. All the patients failed to respond to 6-MP for at least 6 months. Dosage was adjusted to weight (25 mg MTX/1.73m²). Duration of therapy with methotrexate ranged from 4 weeks to 12 months. Results: Remission was achieved in 8/10 patients treated with MTX: modified Harvey-Bradshaw index of disease activity <5 was obtained and cessation of prednisone or weaning to a low dose of prednisone £0.4 mg/kg/die was possible in these patients. One patient discontinued MTX because of side effects (vomiting). In 3 patients, a relapse occurred 3 weeks to 4 months after discontinuation of MTX. Cumulative dose of MTX/patient did not exceed 1.3 gr. Three other patients are still receiving MTX, and one was lost to follow-up. Conclusion: Methotrexate was generally well tolerated and proved to be a satisfactory alternative therapy in the treatment of refractory Crohn’s disease. Unfortunately, among the responders, relapse often occurred quickly after MTX injections were discontinued.

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