PMID- 26469893
OWN - NLM
STAT- MEDLINE
DCOM- 20160126
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 94
IP  - 41
DP  - 2015 Oct
TI  - Safety Profile of Thiopurines in Crohn Disease: Analysis of 893 Patient-Years 
      Follow-Up in a Southern China Cohort.
PG  - e1513
LID - 10.1097/MD.0000000000001513 [doi]
LID - e1513
AB  - Thiopurines have been associated with both clinical improvement and mucosal 
      healing in treating Crohn disease (CD). Unfortunately, the high rate of adverse 
      events (AEs) leading to drug withdrawal represents a major limitation in the use 
      of these drugs.To evaluate the safety of thiopurines in patients with CD. To 
      identify predictive factors associated with the development of thiopurine-induced 
      AEs and withdrawal.This longitudinal cohort study examined patients from a 
      university-based IBD referral center. Time-to-event analysis was performed with 
      the Kaplan-Meier curve. Cox regression analysis was performed to identify 
      potential predictive factors of AEs.Two hundred sixty-seven CD patients on 
      thiopurines were included. A total of 143 AEs occurred at a median of 7.4 months 
      (interquartile range, 3.7-15.3 months) after starting treatment. The cumulative 
      incidence of AEs was 26%, with an annual risk of 4.3% per patient-year of 
      treatment. The most frequent was leucopenia (41/267, 15.36%), followed by 
      infections (29/267, 10.86%). Independent factors predictive of leucopenia were 
      lower baseline hemoglobin (hazard ratio (HR), 0.34; 95% confidence interval (CI) 
      0.18-0.67) and the concomitant use of 5-aminosalicylic acid (HR, 3.05; 95% CI 
      1.44-8.76). Of the 28.44% (76/267) CD patients discontinued therapy, 14.61% due 
      to AEs. A lower body mass index, the presence of extraintestinal manifestation, 
      and the incidence of leucopenia independently predicted thiopurine withdrawal. In 
      total, 37.5% of these patients restarted thiopurines and 52.3% of them had AEs 
      again.About a quarter of patients on thiopurine therapy had AEs during follow-up 
      and 1 of 7 patients had to discontinue thiopurines due to AEs.
FAU - Qiu, Yun
AU  - Qiu Y
AD  - From the Department of Gastroenterology, First Affiliated Hospital of Sun Yat-Sen 
      University, Guangzhou, People's Republic of China.
FAU - Mao, Ren
AU  - Mao R
FAU - Zhang, Sheng-Hong
AU  - Zhang SH
FAU - Li, Man-Ying
AU  - Li MY
FAU - Guo, Jing
AU  - Guo J
FAU - Chen, Bai-Li
AU  - Chen BL
FAU - He, Yao
AU  - He Y
FAU - Zeng, Zhi-Rong
AU  - Zeng ZR
FAU - Chen, Min-Hu
AU  - Chen MH
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Immunosuppressive Agents)
RN  - E7WED276I5 (Mercaptopurine)
RN  - MRK240IY2L (Azathioprine)
SB  - IM
MH  - Adult
MH  - Azathioprine/*adverse effects/therapeutic use
MH  - Body Mass Index
MH  - China
MH  - Crohn Disease/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Mercaptopurine/*adverse effects/therapeutic use
MH  - Prospective Studies
MH  - Regression Analysis
MH  - Retrospective Studies
MH  - Socioeconomic Factors
PMC - PMC4616791
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2015/10/16 06:00
MHDA- 2016/01/27 06:00
PMCR- 2015/10/16
CRDT- 2015/10/16 06:00
PHST- 2015/10/16 06:00 [entrez]
PHST- 2015/10/16 06:00 [pubmed]
PHST- 2016/01/27 06:00 [medline]
PHST- 2015/10/16 00:00 [pmc-release]
AID - 00005792-201510020-00005 [pii]
AID - 10.1097/MD.0000000000001513 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2015 Oct;94(41):e1513. doi: 10.1097/MD.0000000000001513.