Withdrawal of Long-Term Maintenance Treatment with Azathioprine Tends to Increase Relapse Risk in Patients with Crohn's Disease

被引:28
作者
Wenzl, Heimo H. [1 ]
Primas, Christian [2 ]
Novacek, Gottfried [2 ]
Teml, Alexander [2 ]
Oefferlbauer-Ernst, Anna [2 ]
Hoegenauer, Christoph [1 ]
Vogelsang, Harald [2 ]
Petritsch, Wolfgang [1 ,2 ]
Reinisch, Walter
机构
[1] Med Univ Graz, Dept Internal Med, Div Gastroenterol & Hepatol, A-8036 Graz, Austria
[2] Med Univ Vienna, Dept Internal Med 3, Div Gastroenterol & Hepatol, A-1090 Vienna, Austria
关键词
Crohn's disease; Immunomodulators; Azathioprine; Clinical trails; INFLAMMATORY-BOWEL-DISEASE; DOUBLE-BLIND; CLINICAL-TRIALS; ACTIVITY INDEX; 6-MERCAPTOPURINE; REMISSION; EFFICACY; THERAPY; METAANALYSIS; MULTICENTER;
D O I
10.1007/s10620-014-3419-5
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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.
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收藏
页码:1414 / 1423
页数:10
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