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Azathioprine or methotrexate in the treatment of patients with steroid‐dependent or steroid‐resistant ulcerative colitis: results of an open‐label study on efficacy and tolerability in inducing and maintaining remission
Author(s) -
Paoluzi O. A.,
Pica R.,
Marcheggiano A.,
Crispino P.,
Iacopini F.,
Iani C.,
Rivera M.,
Paoluzi P.
Publication year - 2002
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2002.01340.x
Subject(s) - azathioprine , ulcerative colitis , tolerability , medicine , methotrexate , gastroenterology , surgery , adverse effect , disease
Summary Background : The role of azathioprine and methotrexate in inducing and maintaining remission in patients with ulcerative colitis is still controversial. Aim : To evaluate the efficacy and tolerability of these two drugs in a series of patients with steroid‐dependent or steroid‐resistant active ulcerative colitis. Methods : Forty‐two patients were treated with a daily dose of azathioprine (2 mg/kg) and, if intolerant or not responding, with methotrexate (12.5 mg/week intramuscularly), and their efficacy was established by clinical, endoscopic and histological examinations at 6 months. Patients achieving clinical remission continued with treatment and were followed up. Results : Of the 42 patients on azathioprine, 10 experienced early side‐effects requiring withdrawal from treatment, 22 (69%) achieved complete remission, six (19%) achieved improvement and four (12%) obtained no substantial benefit. Methotrexate, administered to eight patients intolerant to and two patients resistant to azathioprine, induced complete remission in six patients (60%) and improvement in four (40%). During follow‐up, a larger number of patients on azathioprine relapsed in comparison with patients on methotrexate [16/28 (57%) vs. 2/10 (20%), respectively; P < 0.05]. Only minor side‐effects wereobserved on both treatments. Conclusions : Azathioprine is effective in patients with steroid‐dependent or steroid‐resistant ulcerative colitis. Methotrexate seems to be a good alternative in patients intolerant to or not responding to azathioprine.