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SUMMARY BackgroundAdalimumab induces and maintains remission in adults with Crohn's disease.

Summary Background : Controlled trials have demonstrated the efficacy of methotrexate in the induction and maintenance of remission in luminal Crohn's disease; however, its effect on fistulizing disease is unknown. Aim : To describe the response to methotrexate therapy in a series of patients with fistulizing Crohn's disease. Methods : A retrospective chart review was conducted of all patients with Crohn's disease receiving methotrexate in one practice. The response of patients with fistulizing and luminal disease was assessed using clinical and laboratory criteria. Fistula response was categorized as either complete or partial closure. Results : Thirty‐seven courses of methotrexate therapy were given to 33 patients with luminal and/or fistulizing Crohn's disease. In 16 patients with fistulas, four (25%) had complete closure, five (31%) had partial closure and all had failed or were intolerant to 6‐mercaptopurine therapy. Overall, response to methotrexate was seen in 23 of 37 (62%) treatment courses in patients with luminal and/or fistulizing Crohn's disease. Two of the 33 patients (6%) had a significant adverse event. Conclusions : In this case series, 56% of patients with Crohn's fistulas on methotrexate showed a complete or partial response to therapy. Further studies are needed to confirm the role of methotrexate alone, and in combination with other therapies, for the treatment of fistulizing Crohn's disease.

In the management of fistulae, the current therapeutic approach is the use of a combination of antibiotics and/or a combination of immunomodulatory agents. However, clinicians treating patients with fistulae, particularly those with fistulizing Crohn’s disease, have little data from controlled clinical trials of these pharmacologic agents or regimens to substantiate their use in treating this complication. Therapy with the anti‐tumour necrosis factor‐alpha antibody, infliximab, has shown promise in treating patients with Crohn’s disease and those with the disease complicated by fistulae. A recent clinical trial was designed specifically to evaluate infliximab in the treatment of fistulizing Crohn’s disease. Study results demonstrated infliximab to be the first therapeutic agent to show statistical efficacy in fistulae closure in a placebo‐controlled trial. Therapy with the chimeric monoclonal antibody was characterized by a rapid onset of closure and a lasting benefit of action. Two patient cases from the clinical trial are presented to exemplify the dramatic effectiveness of this novel therapeutic approach in modulating the immune response of patients with this debilitating complication of Crohn’s disease.

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