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P570 More than 10 years of experience of use methotrexate in Crohn’s disease at Macarena Hospital, Sevilla, Spain

M. F. Guerra Veloz*1, M. B. Maldonado Pérez1, A. Caunedo Álvarez1, L. Castro Laria1, J. L. Cotrina Lino2, F. Argüelles Arias1, A. Flores Cucho2, M. Romero Gómez2

1Unidad de Gestión Clínica de Aparato Digestivo Hospital Universitario Virgen Macarena, Seville, Spain, 2Hospital Universitario Virgen Macarena, Gastroenterology, Sevilla, Spain

Background

Methotrexate (MTX) has proved to be an effective drug in the treatment of rheumatic diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Its utility in inflammatory bowel disease (IBD) has been demonstrated in Crohn’s disease (CD).1

Methods

We developed a descriptive and retrospective study of patients diagnosed with CD in our health area. They perform a maintenance treatment with immunomodulators for IBD. Between 1995 and 2014, histologically confirmed, 688 patients were diagnosed with CD, 51 patients received treatment with MTX. Then we analyse the clinical response to the treatment using the Activity Index of Crohn’s Disease (CDAI) and the removal of the therapy (loss of efficacy / adverse effects; dosage of treatment [route and dose]; administration in monotherapy or adjunctive treatment).

Results

In total, 51 patients with CD were included: 27 men (53%), with a mean age of 39 ± 11 years. Ileal lesions were predominant (L1) in 22 (43%) patients; colonic (L2) in 16 (31%); and ileocolic (L3) in 13 (26%). In 20 patients (39%) perianal disease was associated. Further, 24 of the 51 patients continued the maintenance treatment with MTX. At the mean follow-up of 40 weeks, 50% of the patients were still in monotherapy and 12 patients with other adjuvant treatments, with appropriate response (CDAI <1 50). MTX is suspended in 27 patients: in 5 (19%) for loss of efficacy (median duration of treatment of 20 months); in 14 (51%) it was suspended because of adverse drug reactions (mean treatment duration of 2.27 months); and in 8 (30%) for therapeutic modification (5 to biological, 1 to azathioprine, and 2 to mesalazine). The initial dose for all patients was 25 mg sc / week for the first 3 months. Patients who continue with MTX, currently receive 15 mg sc / wk 16 (67%) patients, 4 (17%) of them in vo 15 mg / wk 2 (8%) patients oral 20 mg / wk and 2 (8 %) 10 mg vo / wk.

Figure 1. Patients in treatment with MTX.

Figure 2. Adverse drug reactions.

Conclusion

Patients, with CD in immunosuppressive treatment with MTX, maintain good clinical remission with adequate tolerance and safety profile. Our patients in adjuvant therapy (mostly with infliximab) remain in remission from the disease probably by a combined effect. Further studies which evaluate the efficacy, dosage, and safety of maintenance treatment with MTX in CD are needed.

References

[1] Gomollón F, Rubio S. Recommendations Spanish Working Group of Crohn’s Disease and Ulcerative Colitis (GETECCU) on the use of methotrexate in inflammatory bowel disease. Gastroenterol Hepatol 2015;38:24–30.