Background Methotrexate (MTX) has been used to maintain remission in patients with Crohn's disease as a second-line maintenance agent following thiopurines. This study was designed to assess the effectiveness of MTX monotherapy or combination therapy in patients with Crohn's disease refractory to anti-tumor necrosis factor (anti-TNFα) agents.

Methods A retrospective, observational single-center study of data from a private clinic was conducted on patients with moderate to severe Crohn's disease who were refractory to anti-TNF- α. Intramuscular weekly injections of MTX was added. The patients were followed for 24 months. Adverse events were recorded.

Results A total of 32 patients were treated with anti-TNF- α and MTX. Eleven (33.3%) patients were female. Perianal disease was seen in 19 patients (59.4%), 4 (12.5%) had Crohn's colitis and 9 (28.1%) had stricturing disease. Clinical response was 75%. Twenty-one patients had complete response and three patients had partial response. Adverse events were recorded in 3 (0.9%) patients and MTX was discontinued in two of them.

Conclusions MTX could be an alternative treatment option compared with azathioprine being added to anti-TNF- α in patients with moderate to severe refractory Crohn's disease.