Efficacy and tolerability of methotrexate therapy for refractory intestinal Behçet's disease: a single center experience

intestinal BD. In this study, we aimed to investigate the effect and tolerability of MTX monotherapy and the combination MTX with adalimumab for patients with refractory intestinal BD. Between March 2005 and February 2017, a total of 606 patients with intestinal BD were registered at the IBD Clinic of Severance Hospital, Seoul, Korea. Patients are diagnosed with intestinal BD if gastrointestinal symptoms are present, and typical ulcerative lesions are documented by objective measures. Patients with refractory intestinal BD were defined as follows: (1) those with active intestinal ulceration based on colonoscopy despite intensive therapy with 5-ASAs, corticosteroids, azathioprine, or anti-TNF-α agents for >8 weeks, and (2) those with steroid dependence. Ten patients were treated with MTX for refractory intestinal BD. The patients received a variety of doses of MTX, which were given either through SC injection or orally on a weekly basis at the discretion of physicians. Adalimumab was administered at a dose of 160 mg in week 0, 80 mg in week 2, and 40 mg every other week for patients with refractory intestinal BD. The primary outcome of interest was corticosteroid-free remission at 3 and 6 months for refractory intestinal BD. The secondary outcomes of interest were disease activity index for the intestinal Behçet’s disease (DAIBD) score, CRP level, and ESR levels at 3 and 6 months. Comparisons were made using a Wilcoxon signed rank test. All statistical analyses were assessed with the SPSS version 23.0 (IBM Corp., Armonk, NY, USA). A P-value of <0.05 was considered statistically significant. Ten patients were treated with MTX for active refractory The conventional treatments for intestinal Behçet’s disease (BD) include 5-aminosalicylic acids (5-ASAs), systemic corticosteroids, and immunosuppressive agents such as thiopurines. However, long-term use of corticosteroids is associated with steroid dependency and resistance, requiring additional immunosuppressant therapy or surgery. Azathioprine and 6-mercaptopurine (6-MP) are associated with bone marrow suppression and reported to occur in 56.4% after treatment with the maximal doses of azathioprine and 6-MP in Korean patients with IBD, which was a considerably higher incidence than that reported in Western studies. Furthermore, BD may be associated with myelodysplastic syndrome, which might hamper the use of thiopurines in such patients. As intestinal BD is often refractory to these agents, the use of anti-tumor necrosis factor-α (anti-TNF-α) agents such as infliximab and adalimumab has recently been encouraged for the management of intestinal BD. A modest increase in the incidence of serious infection with biologics has been observed in methodologically rigorous studies. Methotrexate (MTX), an analogue of folic acid and aminopterin, has antineoplastic function at high doses and inhibits lymphocyte proliferation and pro-inflammatory cytokines at low doses. MTX is currently being increasingly used in combination with anti-TNF-α agents to prevent immunogenicity in patients with CD. To our knowledge, few