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Randomized controlled azathioprine withdrawal after more than two years treatment in Crohn's disease: increased relapse rate the following year
Author(s) -
Vilien M.,
Dahlerup J. F.,
Munck L. K.,
Nørregaard P.,
Grønbæk K.,
Fallingborg J.
Publication year - 2004
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 - 10.1111/j.1365-2036.2004.01944.x
Subject(s) - azathioprine , medicine , crohn's disease , gastroenterology , randomized controlled trial , clinical endpoint , disease , surgery
Summary Introduction : Azathioprine is effective for maintenance of remission in Crohn's disease, however, duration of efficacy and the dose response relationship has not been fully evaluated. Aims : To investigate whether patients kept in remission by azathioprine treatment for >2 years benefit from further treatment, and to explore dose–response relationship. Patients and methods : In an open 12‐month trial, patients with inactive Crohn's disease after >2 years (median 37 months) of azathioprine treatment were randomized to azathioprine withdrawal or continued treatment. Primary end point was relapse defined as: (i) Crohn's disease activity index rise ≥ 75, and Crohn's disease activity index >150 or (ii) disease activity requiring intervention. Results : Of 29 patients, 28 completed the observation period or relapsed. Eleven of 13 patients (85%) continuing azathioprine remained in remission compared with seven of 15 (47%) observed without azathioprine ( P = 0.043). In patients who had been treated with azathioprine >1.60 mg/kg/day the difference was even more pronounced, eight of nine (89%) vs. four of 12 (33%) respectively ( P = 0.017). Conclusions : Patients with Crohn's disease in remission after >2 years of continuous azathioprine treatment will benefit from further continued treatment. Further controlled studies with azathioprine doses <2.0 mg/kg/day are needed.