Objective: To assess the efficacy and safety of methotrexate(MTX) on refractory Crohn's disease(CD).
Methods: A total of 35 consecutive refractory CD patients in the First Affiliated Hospital of Sun Yat-Sen University treated with MTX were retrospectively analyzed. Clinical data from June 2004 to December 2012 were collected from the database of inflammatory bowel disease (IBD) center. Clinical responses and drug side effects were recorded and analyzed.
Results: Thirty-five refractory CD patients were identified including 23 cases intolerant to azathioprine (AZA)/6-mercaptopurine(6-MP), six cases ineffective to AZA/6-MP, 19 cases dependent on steroid. After treatment of MTX for 12 weeks [15(5-20) mg/week], a clinical response was obtained in 80% patients (28/35), including 51.4% (18/35) in remission and 28.6% (10/35) in improvement. The median Crohn's disease activity index (CDAI) scores at the onset and 12 weeks after MTX therapy were 99.2 (75.8, 174.7) and 61.5 (36.0, 106.6) respectively. The median single dose and duration of MTX were 15 (5-20) mg/week and 6.0(0.5-53.0) months respectively. The median cumulative dose was 480 (20-2615) mg. Among the 26 patients dependent on steroid, 21 achieved discontinuation of steroid with a median time of 10 (6-20) weeks after treatment of MTX. Side effects were recorded in 12 patients (34.3%), but usually mild and improved after drug with drawal.
Conclusions: MTX is an effective and steroid-sparing agent for refractory CD. Side effects of MTX are mild and tolerable.