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J Dig Dis. 2016 Nov;17(11):747-755. doi: 10.1111/1751-2980.12414.

Standard-dose versus low-dose azathioprine in the treatment of Crohn's disease: A prospective randomized study.

Zhang Y1,2, Xia JJ3, Xiao P1,2, Zhao Y1,2, Ye LN1,2, Li XL1,2, Lin ZW1,2, Xu ZJ1,2, Huang YB1,2, Wang MY1,2, Qian JM4, Hu PJ5, Cao Q1,2.

Author information

1
Department of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang Province, China.
2
Inflammatory Bowel Disease Center, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
3
Department of General Practice, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China.
4
Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.
5
Department of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong Province, China.

Abstract

OBJECTIVE:

Azathioprine (AZA) is widely used to treat Crohn's disease (CD) with a recommended dose of 2-2.5 mg/kg per day for Westerners. Asian patients are suggested to take a lower dose. However, many clinicians reported poor efficacy with a reduced dose. This study aimed to explore a efficient and safe dose of AZA providing the best efficacy for Chinese CD patients.

METHODS:

Fifty patients with active CD were enrolled and randomized into two groups (n = 25 each). All other treatments were the same except that group A received 1 mg/kg per day and group B took 2 mg/kg per day of AZA. Complete remission (CR) rate and response rate at weeks 12, 24 and 48 were assessed by using intent-to-treat (ITT) and per-protocol (PP) analyses. Adverse events and recurrence rate were also evaluated.

RESULTS:

At week 48, CR rate and response rate in group B (ITT: 50.0% and 59.1%; PP: 57.9% and 68.4%) were significantly higher than those in group A (ITT: 13.0% and 17.4%; PP: 16.7% and 22.2%) (P < 0.05). Nine adverse events occurred, including pancreatitis (n = 1), arthritis (n = 2) and myelosuppression (n = 6). There was no significant difference in adverse events between the two groups. However, recurrence rate was significantly higher in group A than in group B (P = 0.042).

CONCLUSION:

AZA 2 mg/kg per day is more appropriate than 1 mg/kg per day for Chinese CD patients with a high efficacy, a low recurrence rate and not increased adverse events.

KEYWORDS:

Crohn's disease; adverse event; azathioprine; dose; efficacy

PMID:
27653444
DOI:
10.1111/1751-2980.12414
[Indexed for MEDLINE]

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