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P184. Effectiveness and tolerability of maintenance methotrexate therapy in Crohn's disease patients; Analysis of a referral hospital-based 10-years intercept cohort

M.L. Seinen, N.K.H. de Boer, C.J.J. Mulder, G. Bouma, A.A. van Bodegraven

VU University Medical Center, Amsterdam, The Netherlands

Background and Aim: Methotrexate (MTX) is a frequently administered immunomodulating drug for the treatment of Crohn's disease (CD). Unfortunately, limited longterm data are available. The aim of this study is to assess the maintenance effectiveness and tolerability of methotrexate (MTX) as maintenance therapy in Crohn's disease patients.

Material and Methods: A referral hospital-based, intercept cohort from January 1st, 2000, until January 1st, 2010 was explored to evaluate all consecutive MTX-using CD-patients. In this retrospective study, these patients were selected from a prospectively maintained database concerning all IBD-patients. MTX was initiated in patients after previous immunosuppressive therapies (mostly thiopurine, or combination with anti-TNFα), according to a step-up protocol. Therapeutic effectiveness was assessed by calculating the cumulative number of patients still using MTX with a dosage of at least 15 mg/week at 6, 12, 24 and 60 months after initiation of MTX therapy and were considered to be in clinical remission, based on global physician's assessment, laboratory, radiological and/or endoscopic findings. Reasons for discontinuation of MTX were subclassified into adverse events, ineffectiveness, patient's request, pregnancy wish and others.

Results: Seventy-eight CD-patients (57 females) were included. The median duration of IBD at initiating MTX therapy was 4 years (IQR 2–13 years) with a median age of 36 years (IQR 26–45 years). Fourty-eight patients (62%) initiated MTX therapy due to an adverse reaction to thiopurines, 17 patients due ineffectiveness of thiopurines, 3 patients had an adverse reaction to combination therapy of thiopurine and a biological and in 9 patients ineffectiveness of combination therapy. MTX therapy was discontinued in 49 patients (63%) after a median duration of 33 weeks (IQR 12–99 weeks) due to adverse events (35%), ineffectiveness (39%), patient's request (10%), pregnancy wish (8%), others (6%) and 1 unknown. Median duration of MTX use in the 29 patients who continued therapy was 162 weeks (IQR 101–231 weeks). In 8 of these 29 patients a biological agent was added after initiating MTX therapy due to ineffectiveness of monotherapy with MTX. The proportion of patients still using MTX at 6, 12, 24 and 60 months was, 73%, 59%, 44% and 9% respectively.

Conclusion: After one year of MTX-therapy, effectiveness was established in 59 percent in CD patients. This percentage decreased to 9% after 5 years, mainly due to ineffectiveness or adverse reactions.