Methotrexate in inflammatory bowel disease:  a multicenter retrospective study focused on long-term efficacy and safety. The Madrid experience.
BACKGROUND
Methotrexate is useful in inflammatory bowel disease (IBD), but its role is secondary because of its limited experience and a supposedly unfavorable safety profile.


OBJECTIVE
To describe the efficacy and safety of methotrexate in a long-term real clinical practice.


METHODS
Retrospectively reviewed records of IBD patients treated with methotrexate in eight hospitals of Madrid (Spain).


RESULTS
A total of 77 patients were included (80% Crohn's disease); 94% received methotrexate because of steroid dependency. Overall, 82% of the patients initially responded (28% remission). Eighty-eight percent of the patients followed maintenance treatment for a mean of 17 (range: 1-108) months. Forty percent of the patients lost response at a mean of 57 weeks after starting methotrexate. No statistically significant differences were found in the response rates in terms of the disease type, route of administration, or the Montreal Classification category. The mean methotrexate cumulative dose was 1108 mg (range: 25-6480). The main adverse events included 10 cases of gastrointestinal symptoms, four of myelotoxicity, and 10 of abnormal liver function tests, and led to methotrexate withdrawal in four (5%) patients. Transient elastography, performed in 46 patients, detected six additional cases with significant fibrosis and normal liver function tests.


CONCLUSIONS
Methotrexate is useful in inducing a response in IBD, although its efficacy decreases frequently through the follow-up. Although methotrexate seems safe in the long term, in addition to biochemical controls, a more accurate method to detect liver damage should be considered.
Digestive Department, Net Center for Biomedical Research in Liver and Digestive Diseases (CIBERHED), La Princesa Institute for Health Research (IP), La Princesa University Hospital, Madrid, Spain.
Yago
Y
González-Lama
Carlos
C
Taxonera
Antonio
A
López-Sanromán
José Lázaro
JL
Pérez-Calle
Fernando
F
Bermejo
Ramón
R
Pajares
Adrian G
AG
McNicholl
Verónica
V
Opio
Juan Luis
JL
Mendoza
Pilar
P
López
Alicia
A
Algaba
Jesús
J
Estelles
Almudena
A
Barbero
Jorge
J
Mendoza
José
J
Maté
Javier P
JP
Gisbert
D000328:Adult; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D012189:Retrospective Studies; D013030:Spain; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D008727:Methotrexate