Effects of discontinuing anti-tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure.

BACKGROUND & AIMS: We assessed the course of inflammatory bowel disease (IBD) among pregnant women who stopped taking anti-tumor necrosis factor (TNF) agents. We also analyzed levels of anti-TNF agents in cord blood samples. METHODS: We followed 31 pregnancies in 28 women with IBD between April 2006 and April 2011 who were treated with anti-TNF agents (18 received infliximab, and 13 received adalimumab) during pregnancy. We used enzyme-linked immunosorbent assays to measure levels of anti-TNF agents in cord blood collected from 18 newborns (12 whose mothers took infliximab, and 6 whose mothers took adalimumab). RESULTS: Among the patients taking infliximab, 12 (71%) discontinued treatment before gestational week 30; all patients remained in remission. All the patients taking adalimumab discontinued treatment before gestational week 30; two patients had relapses of IBD. There were 28 live births, 1 miscarriage among patients taking infliximab (at gestational week 6), and 2 miscarriages among patients taking adalimumab (at weeks 6 and 8); there were no congenital malformations. The mean cord blood level of infliximab was 6.4 ± 1.6 µg/mL; it was significantly lower among women who received the drug 10 weeks or less before delivery (2.8 ± 1.1 µg/mL) than those who received infliximab closer to delivery (10 ± 2.3 µg/mL; P = .02). Adalimumab was detected in 5 samples of cord blood (mean concentration, 1.7 ± 0.4 µg/mL); 1 cord blood sample from a woman who discontinued the treatment at gestational week 22 had an undetectable level of the drug. CONCLUSIONS: Discontinuation of anti-TNF therapy appears to be safe for pregnant women with quiescent IBD. However, these drugs are still detected in cord blood samples.

The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands.

OBJECTIVES: Colonoscopy is the gold standard for visualization of the colon. It is generally accepted as a safe procedure and major adverse events occur at a low rate. However, few data are available on structured assessment of (minor) post-procedural adverse events. METHODS: Consecutive outpatients undergoing colonoscopy were asked for permission to be called 30 days after their procedure. A standard telephone interview was developed to assess the occurrence of (i) major adverse events (hospital visit required), (ii) minor adverse events, and (iii) days missed from work. Adverse events were further categorized in definite-, possible-, and unrelated adverse events. Patients were contacted between January 2010 and September 2010. RESULTS: Out of a total of 1,528 patients who underwent colonoscopy and gave permission for a telephone call, 1,144 patients were contacted (response: 75%), 49% were male, the mean age was 59 years (s.d.: 14). Thirty-four patients (3%) reported major adverse events. These were definite-related in nine (1%) patients, possible-related in 6 (1%), and unrelated in 19 patients (2%). Minor adverse events were reported by 466 patients (41%). These were definite-related in 336 patients (29%), possible-related in 36 (3%), and unrelated in the remaining 94 patients (8%). Female gender (odds ratio (OR): 1.5), age <50 years (OR: 1.5), colonoscopy for colorectal cancer screening/surveillance (OR: 1.6), and fellow-endoscopy (OR: 1.7) were risk factors for the occurrence of any definite-related adverse event. Patients who reported definite-related adverse events were significantly less often willing to return for colonoscopy (81 vs. 88%, P<0.01) and were less often positive about the entire colonoscopy experience (84 vs. 89%, P=0.04). CONCLUSIONS: Structured assessment of post-colonoscopy adverse events shows that these are more common than generally reported. Close to one-third of patients report definite-related adverse events, which are major in close to 1 in 100 patients. The occurrence of adverse events does have an impact on the willingness to return for colonoscopy.