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Withdrawal of Long-Term Maintenance Treatment with Azathioprine Tends to Increase Relapse Risk in Patients with Crohn's Disease.
- Source :
-
Digestive Diseases & Sciences . May2015, Vol. 60 Issue 5, p1414-1423. 10p. - Publication Year :
- 2015
-
Abstract
- Background and Aim: Many patients with quiescent Crohn's disease are maintained on long-term treatment with azathioprine (AZA), but controlled data are limited. We aimed to evaluate the efficacy of AZA therapy for more than 4 years to maintain clinical remission. Methods: We performed a randomized double-blind placebo-controlled AZA withdrawal trial with a follow-up period of 24 months. Patients had to have continuous AZA therapy ≥4 years without exacerbation of disease during the 12 months before enrollment, and a Crohn's disease activity index <150 at baseline. Patients were randomized to continue on AZA or switch to placebo. The primary endpoint was time to clinical relapse during follow-up. Results: After inclusion of 52 patients, the trial was stopped prematurely due to slow recruitment. During the 2-year follow-up, clinical relapse occurred in 4 of 26 (15 %) patients on continued AZA and in 8 of 26 (31 %) patients on placebo. Time to clinical relapse averaged 22.3 months (95 % CI 20.6-24.0) on AZA and 19.2 months (95 % CI 16.4-22.1) on placebo ( p = 0.20). According to life-table analysis, the proportion of patients in remission after 12 and 24 months was 96 ± 4 and 86 ± 7 % in patients receiving AZA versus 76 ± 8 and 68 ± 9 % in patients receiving placebo (month 12, p = 0.035; month 24, p = 0.30). A higher AZA dose at enrollment was an independent predictor for relapse ( p < 0.05). Conclusions: AZA withdrawal resulted in a significantly increased relapse risk after 1 year and a nonstatistically significant trend for relapse after 2 years. Our results are in line with previous observations. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01632116
- Volume :
- 60
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Digestive Diseases & Sciences
- Publication Type :
- Academic Journal
- Accession number :
- 102601498
- Full Text :
- https://doi.org/10.1007/s10620-014-3419-5