Area Editoriale
Due surveys multicentriche, una spagnola ed una italiana, sono concordi nel rilevare che solo una piccola quota di pazienti con colite ulcersa viene trattata con metotrexate, ma che le percentuali di successo terapeutico sono sovrapponibili a quelle rilevate in studi analoghi con le tiopurine
Methotrexate in ulcerative colitis: a Spanish multicentric study on clinical use and efficacy.Mañosa M, García V, Castro L, García-Bosch O, Chaparro M, Barreiro-de Acosta M, Carpio D, Aguas M. J Crohns Colitis. 2011;5:397-401.
BACKGROUND: Few data are available on the efficacy of methotrexate (MTX) in ulcerative colitis (UC). AIM: To evaluate the efficacy and safety of MTX in UC patients. PATIENTS AND METHODS: UC patients who had been treated with MTX were identified from the databases of 8 Spanish IBD referral hospitals. Patients were included in the study if they received MTX for steroid dependency or steroid refractoriness. Therapeutic success was defined as the absence of UC-related symptoms, complete steroid withdrawal and no requirement of rescue therapies within the first 6 months after starting MTX. RESULTS: Forty patients were included, 70% treated for steroid dependency and 27% for steroid refractoriness. Thiopurines had been previously attempted in 87.5% of
patients. The median dose of MTX used for induction was 25mg (IIQ 17.5-25) weekly given parenterally in 82.5% of cases. Eighty-five percent of patients were on steroids when MTX was started. Forty-five percent of patients met criteria for therapeutic success. Initial treatment failures were mainly due to inefficacy (50%) or intolerance (36%). After a median follow-up of 28 months (IQR 22-47), 38% of patients with initial therapeutic success required new steroid courses, 22% started biological therapy, and only 1 patient required colectomy. The cumulative probability of maintaining steroid-free clinical remission was 60%, 48%, and 35% at 6, 12, and 24 months after starting MTX, respectively. Eleven patients (27.5%) experienced adverse events, leading to MTX discontinuation in only 8 of them. CONCLUSIONS: MTX appears to be effective to maintain clinical remission in UC, at least in the short-term, with an acceptable safety profile.
The use of methotrexate for treatment of inflammatory bowel disease in clinical practice.Saibeni S, Bollani S, Losco A, Michielan A, Sostegni R, Devani M, Lupinacci G, Pirola L, Cucino C, Meucci G, Basilisco G, D'Incà R, Bruno S. Dig Liver Dis. 2011 Nov 1. [Epub ahead of print]
BACKGROUND: Methotrexate is considered a treatment for Crohn's disease, whilst few data in ulcerative colitis are available. AIM: To evaluate frequency, indications, efficacy and safety of methotrexate in inflammatory bowel disease patients. METHODS: 5420 case histories were reviewed. RESULTS: Methotrexate was prescribed to 112 patients (2.1%; 89 Crohn's disease, 23 ulcerative colitis). It was the first-line immunosuppressive option in 32 (28.6%), it was an alternative drug due to toxicity or failure of thiopurines in 80 (71.4%). Steroid-dependence represented the main indication both when it was used as first (13/32, 40.6%) and second option (41/80, 51.2%). Efficacy was considered optimal in 39/112 (34.8%), partial in 29/112 (25.9%), absent in 22/112 (19.6%), not assessable in 22/112
(19.6%). Side effects happened in 49 out of 112 patients (43.7%) (39 Crohn's disease, 10 ulcerative colitis), leading to drug discontinuation in 38 (33.9%). The occurrence of side effects was approximately fivefold higher in patients who did not receive folic acid (14/19, 73.7%) than in those who did (35/93, 37.6%): odds ratio 4.64, 95% confidence interval 1.54-14.00; p=0.005. CONCLUSIONS: The use of methotrexate appears to be negligible in clinical practice. However, our results suggest that, if appropriately used, methotrexate could be more widely administered to inflammatory bowel disease patients with complicated disease.