Methotrexate (MTX) is frequently used as the major maintenance treatment in children with Crohn’s disease (CD) despite the paucity of data. For a study, researchers sought to determine baseline prognostic variables and evaluate the efficacy of MTX as the “first” primary maintenance treatment in newly diagnosed mild/moderate pediatric CD.

Single-center review of newly diagnosed CD patients who received MTX as their major maintenance medication for 10 years. When patients advanced to anti-TNF medication within a year, they compared their baseline features to those of patients with durable responses or clinical remission. Remission was defined as the Pediatric Crohn’s Disease Activity Index (PCDAI) ≤10.

They identified 65 patients (mean age, 11.8 years; 72% male; mean ±SD PCDAI, 17.8±10.5) who began using MTX as their main maintenance medication within four months of diagnosis. Corticosteroids (CS) (54/65), a specific diet (4/65), and a combination of CS/diet (6/65) were the first treatments used before MTX. Mean dosage of 11.4 mg/m2 orally and 12.5 mg/m2 subcutaneously was utilized; oral dosing was employed in 55% of cases. At 1 year, 32 of the 65 patients (or 55%) receiving MTX monotherapy were in clinical remission; 81% had been in steroid-free remission throughout the year after induction. At one year, 14 (39%) of the 36 patients on MTX (or 22% of the initial sample) exhibited substantial mucosal healing. About 37% of all patients had better or healed mucosa in ten additional patients. Around 15 patients (or 23%) failed early and switched to anti-TNF therapy after less than 4 months. The result was not predicted by baseline PCDAI, hemoglobin, ESR, albumin, or delivery method. Only 1 patient in the cohort discontinued MTX because of increased aminotransferases, indicating that the drug was well tolerated. In the year of follow-up, no patient required CD surgery.

In mild to severe CD, MTX could be the major maintenance drug.