Reduction in surgical stoma rates in Crohn's disease: a population-based time trend analysis.

AIM: Trends in surgical rates for Crohn's disease (CD) in the biological era are controversial. We aim to assess modern trends in the formation rates of surgical stomas. METHOD: Population-based surveillance in the Calgary Health Zone (CHZ), Canada, was conducted between 1 April 2002 and 31 March 2011, using the Discharge Abstract Database to identify adult patients with CD admitted to hospital and treated with surgical stoma formation (n = 545). Annual stoma incidence was calculated by dividing the number of incident stomas by the prevalence of CD in the CHZ. Time trend analysis of the stoma-formation rate was performed, expressed as annual percentage change (APC) with 95% CI. Stoma-formation rates were stratified according to procedure (emergency vs elective) and duration of stoma [temporary (reversed within 2 years of formation) vs permanent]. RESULTS: The overall rate of stoma formation between 2002 and 2011 showed a downwards trend, of a mean of 5.2% (95% CI: -8.5 to -1.8) per year, from a rate of 2.30 stomas/100 person-years (PY) in 2002 to 1.51 stomas/100 PY in 2011. The rate of emergency stoma formation decreased significantly from 2002 to 2011 (mean APC = -9.4%; 95% CI: -15.6 to -2.8), while the rate of elective ostomies essentially showed no change (mean APC = -0.9%; 95% CI: -5.3 to 3.8). The rate of temporary stoma formation decreased significantly, by 4.6% (95% CI: -7.3 to -1.8) per year, while permanent stoma formation was stable (APC = 1.0%; 95% CI: -4.0 to +6.3). CONCLUSION: A reduction in the overall rate of stoma formation in CD has been driven by fewer emergency stomas, although rates of permanent stoma have remained stable.

The effects of pregnancy on the pharmacokinetics of infliximab and adalimumab in inflammatory bowel disease.

BACKGROUND: Transplacental transfer of infliximab and adalimumab results in detectable drug levels in the cord blood and infant. AIM: To determine if pregnancy influenced the pharmacokinetics of anti-TNF agents in women with inflammatory bowel disease. METHODS: Twenty-five women from the University of Calgary inflammatory bowel disease(IBD) pregnancy clinic on maintenance infliximab or adalimumab were recruited prospectively with serum bio-banking performed each trimester. Infliximab trough and adalimumab steady-state levels were the outcomes of interest and were analysed using the ANSER infliximab and adalimumab assays. Multivariate linear mixed-effects models were constructed to assess infliximab and adalimumab drug levels during pregnancy adjusting for the clinical covariates of albumin, BMI and CRP. RESULTS: Fifteen women (eight Crohn's disease, seven ulcerative colitis) received infliximab and 10 women with 11 pregnancies were treated with adalimumab. Median age was 29.6 years (IQR: 27.6-31.2 years). Median disease duration was 9.2 years (IQR: 3.16-15.0 years). Median trough infliximab concentrations were 8.50 µg/mL (IQR: 7.23-10.07 µg/mL), 10.31 µg/mL (IQR: 7.66-15.63 µg/mL) and 21.02 µg/mL (IQR: 16.01-26.70 µg/mL) at trimesters 1, 2 and 3 respectively. Significant changes in albumin and BMI (P < 0.05) but not CRP (P > 0.05) were documented throughout pregnancy. After adjusting for albumin, BMI and CRP, infliximab trough levels increased during pregnancy, by 4.2 µg/mL per trimester (P = 0.02), while adalimumab drug levels remained stable (P > 0.05). CONCLUSIONS: Infliximab levels rise during pregnancy, whereas adalimumab levels remain stable after accounting for changes in albumin, BMI and CRP. Therapeutic drug monitoring in the second trimester may be useful in guiding dosing in the third trimester.