Although there was little evidence supporting its use, methotrexate (MTX) is frequently used as a first-line maintenance treatment for children with Crohn’s disease (CD). The goals of this study were to evaluate the efficacy of MTX as “initial” primary maintenance therapy for children with newly diagnosed mild/moderate CD and to identify baseline predictive markers for this population. A retrospective study of newly diagnosed CD patients treated with MTX as primary maintenance therapy over a 10-year period at a single center. Patients who achieved a long-term response or clinical remission on anti-TNF treatment were compared to those who progressed to the next level of treatment within a year. Remission was defined as having a Pediatric Crohn’s Disease Activity Index (PCDAI) of less than equal to 10.  Researchers found 65 patients (mean age, 11.8 years; 72% male; mean ± SD PCDAI, 17.8±10.5) who initiated MTX in less than equal to 4 months of diagnosis for primary maintenance treatment. Corticosteroids (CS) (54/65), a defined diet (4/65), and a combination of CS and diet (6/65), were the first lines of treatment before MTX was introduced. For 55% of patients, the oral route was used; the average oral dose was 11.4 mg/m2 and the subcutaneous dose was 12.5 mg/m2. At 1 year, 36 of 65 (55%) were on MTX monotherapy, and of those, 32 of 36 were in clinical remission; 81% were in steroid-free remission for the year following induction.   After 1 year, 14 (39%) of the 36 patients on MTX had achieved substantial mucosal healing (22% of the initial group). Mucosal improvement was observed in 10 additional patients (37% overall). About 15 patients, or 23%, experienced early failure and switched to anti-TNF treatment within less than equal to 4 months of treatment. There was no correlation between the result and baseline Pediatric Crohn’s Disease Activity Index (PCDAI), hemoglobin, erythrocyte sedimentation rate (ESR), albumin, or delivery route. Only 1 patient in their dataset discontinued MTX treatment due to abnormally high aminotransferases, suggesting that the drug was well tolerated overall. Within the 1-year follow-up period, no patient needed CD surgery. In mild to moderate CD, MTX may play a more important role in maintenance.

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