Long-term outcome of patients with Crohn's disease who respond to azathioprine.

BACKGROUND & AIMS: Little is known about the long-term outcomes of patients with Crohn's disease (CD) who have a complete response to therapy with azathioprine. We assessed the long-term effects of azathioprine in responders. METHODS: We collected data from the MICISTA registry (a database from the Rothschild and Saint-Antoine Hospitals, Paris, France) on consecutive CD patients treated with azathioprine from 1987 to 1999 who responded to therapy (steroid-free clinical remission at 1 y); they were followed up until 2011 (n = 220; 86 men; median age, 32 y; median follow-up period, 12.6 y). Data were compared with those from 440 matched patients with CD who did not receive immunosuppressants during the same inclusion period (controls). RESULTS: The cumulative rate of sustained remission 10 years after treatment with azathioprine was 38%. Among patients exposed to azathioprine during a prospective follow-up period (1995-2011, 1936 patient-years), the percentage of patient-years with active disease (flare or complication during the calendar year) was 17.6%. Compared with the control group, at baseline, responders were more often active smokers with significantly more extensive disease, perianal lesions, and extradigestive manifestations. During follow-up evaluation, responders had a significantly reduced risk of intestinal surgery (adjusted odds ratio, 0.69; 95% confidence interval, 0.52-0.91) and perianal surgery (adjusted odds ratio, 0.36; 95% confidence interval, 0.27-0.46). A significantly higher percentage of responders developed cancers, including nonmelanoma skin cancers, compared with controls (9.5% vs 4.1%; P < .01). Survival rates after 20 years were 92.8% ± 2.3% of responders vs 97.9% ± 0.8% of controls (P = .01). CONCLUSIONS: Based on a study at a single center, patients with CD who responded to azathioprine had a smaller proportion of patient-years with active disease, and were less likely to be hospitalized or undergo intestinal surgery, than patients with CD who did not receive immunosuppressants. These benefits, however, could be offset by an increased risk of malignancies.

Pregnancy outcome in patients with inflammatory bowel disease treated with thiopurines: cohort from the CESAME Study.

BACKGROUND AND AIMS: Few studies have been conducted addressing the safety of thiopurine treatment in pregnant women with inflammatory bowel disease (IBD). The aim of this study was to evaluate the pregnancy outcome of women with IBD who have been exposed to thiopurines. METHODS: 215 pregnancies in 204 women were registered and documented in the CESAME cohort between May 2004 and October 2007. Physicians documented the following information from the women: last menstrual date, delivery term, details of pregnancy outcome, prematurity, birth weight and height, congenital abnormalities, medication history during each trimester, smoking history and alcohol ingestion. Data were compared between three groups: women exposed to thiopurines (group A), women receiving a drug other than thiopurines (group B) and women not receiving any medication (group C). RESULTS: Mean age at pregnancy was 28.3 years. 75.7% of the women had Crohn's disease and 21.8% had ulcerative colitis, with a mean disease duration of 6.8 years at inclusion. Of the 215 pregnancies, there were 138 births (142 newborns), and the mean birth weight was 3135 g. There were 86 pregnancies in group A, 84 in group B and 45 in group C. Interrupted pregnancies occurred in 36% of patients enrolled in group A, 33% of patients enrolled in group B, and 40% of patients enrolled in group C; congenital abnormalities arose in 3.6% of group A cases and 7.1% of group B cases. No significant differences were found between the three groups in overall pregnancy outcome. CONCLUSIONS: The results obtained from this cohort indicate that thiopurine use during pregnancy is not associated with increased risks, including congenital abnormalities.