Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study.

OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs in utero with that of children who were not exposed to the drugs. METHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring. RESULTS: The study population comprised 841 children, of whom 388 (46%) had been exposed to anti-TNFα agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6% vs. 2.8% per person-year, hazard ratio 1.2 (95% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5% (1.5-4.3)). CONCLUSIONS: In utero exposure to anti-TNFα drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children.

The natural history of COVID-19 in vaccinated inflammatory bowel disease patients.

AIM: Assess the characteristics of break through COVID-19 in Inflammatory Bowel Disease (IBD) patients, despite complete vaccination. METHODS: Patients who reported a COVID-19 at least 3 weeks after complete vaccination were asked to answer an on-line anonymous questionnaire which included patient and disease characteristics, vaccination history, and the evolution of COVID-19. RESULTS: Among 3240 IBD patients who reported complete vaccination between 1st May 2021 and 30thJune 2022, 402 (12.4%) were infected by SARS Cov-2 [223 male, 216 Crohn's disease (CD), 186 Ulcerative Colitis (UC), mean (SD) age 42.3 (14.9) years, mean (SD) IBD duration 10.1 (9.7) years]. Three hundred and sixty-nine patients (91.8%) were infected once and 33 (8.2%) twice. The mean (SD) time between last vaccination and infection was 4.1 (1.6) months. Overall, 351 (87.3%) patients reported mild constitutional and/or respiratory symptoms, 34 (8.4%) were asymptomatic and only 17 patients (4.2%) required hospitalization. Of hospitalized patients, 2 UC patients died of COVID-19 pneumonia. The remaining hospitalized patients did not need high flow oxygen supply or ICU admission. CONCLUSIONS: A minority of completely vaccinated IBD patients developed COVID-19 which evolved with mild symptoms and a favorable outcome. These results reinforce the importance of vaccination especially in vulnerable populations.

Comparison of standard vs high-definition, wide-angle colonoscopy for polyp detection: a randomized controlled trial.

AIM: We sought to compare the performance of colonoscopy using a high-definition, wide-angle endoscope vs a standard colonoscope for the detection of polyps. METHOD: A total of 390 patients were prospectively randomized into high-definition colonoscopy group (HD, n = 193) and standard colonoscopy group (SC, n = 197). RESULTS: Analysis demonstrated that there were significant differences between the two groups, as far as the overall rate of polyps (SC, 1.31 ± 1.90; HD, 1.76 ± 2.31; P = 0.03) and the rate of small hyperplastic polyps (size < 5 mm; SC, 0.10 ± 0.36; HD, 0.25 ± 0.61; P = 0.003) were concerned. No significant differences between the two groups were observed, regarding large polyps (size ≥ 10 mm; SC, 0.39 ± 0.89; HD, 0.48 ± 0.80; P = 0.10), medium polyps (10 mm > size ≥ 5 mm; SC, 0.60 ± 1.46; HD, 0.58 ± 1.25; P = 0.31) and small polyps (size < 5 mm; SC, 0.32 ± 0.86; HD, 0.71 ± 1.65; P = 0.09). Similarly, no significant differences were demonstrated in the detection rate of adenomas and hyperplastic polyps, large adenomas, medium adenomas, small adenomas and large and medium hyperplastic polyps. CONCLUSION: High-definition colonoscopy led to a significant increase in the polyp detection.

Efficacy of bispectral index monitoring as an adjunct to propofol deep sedation for ERCP: a randomized controlled trial.

BACKGROUND AND STUDY AIMS: We sought to determine whether bispectral index (BIS) monitoring is a useful adjunct to the administration of propofol titrated to deep sedation, as measured by reductions of doses of propofol administered during endoscopic retrograde cholangiopancreatography (ERCP). PATIENTS AND METHODS: 90 consecutive patients undergoing ERCP were randomized to receive propofol titrated to deep sedation, with the BIS value either visible (BIS group, n = 46) or invisible (control group, n = 44) to the anesthesiologist. In the BIS group, the anesthesiologist was instructed to use the BIS value as the primary end point for titration of sedation, and to target BIS values between 40 and 60. For the control group, the anesthesiologist was instructed to titrate propofol according to routine practice in the unit using the modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale (MOAA/S score 0). RESULTS: The mean (SD) propofol doses (mg/min per kg weight) were 0.139 (0.02) and 0.193 (0.02) for the BIS and control groups, respectively (P < 0.001). Mean (SD) BIS values throughout the procedure were 61.68 (7.5) and 56.93 (4.77) for the BIS and control groups, respectively (P = 0.001). During the maintenance phase of sedation (MOAA/S score 0), the mean (SD) BIS values were 53.73 (8.67) and 45.65 (4.39) for the BIS and control groups, respectively (P < 0.001). CONCLUSIONS: Our data suggest that BIS monitoring led to a reduction in the mean propofol dose when the BIS value was used as the primary target for sedation in ERCP procedures.

Inflammatory Bowel Disease [IBD] and Physical Activity: A Study on the Impact of Diagnosis on the Level of Exercise Amongst Patients With IBD.

BACKGROUND AND AIMS: Inflammatory bowel disease [IBD] can impair patients' functional capacity with significant negative effects on their quality of life. Our aim was to determine the impact of IBD diagnosis on fitness levels and to assess the levels of engagement in physical activity and fatigue in IBD patient before and after diagnosis. METHODS: A prospective multi-centre cross-sectional study was performed. Patients diagnosed with IBD in the previous 18 months were recruited. Inclusion criteria included clinical remission and/or no treatment changes within the previous 6 months. Physical exercise levels were assessed by the Godin score and fatigue levels was assessed by the functional assessment of chronic illness therapy [FACIT] score. RESULTS: In total, 158 patients (100 Crohn's disease [CD]) were recruited. Mean age was 35.1 years (95% confidence interval [CI] ± 2.0). Gender distribution was approximately equal [51.3% male]. The Mean Harvey Bradshaw and Simple Clinical Colitis Activity indices were 2.25 [95% CI ± 0.40] and 1.64 [95% CI ± 0.49], respectively. The mean Godin score difference before and after IBD diagnosis was 6.94 [p = 0.002]. Patients with ulcerative colitis [UC] [41.8%] were more likely than patients with CD [23.0%] to reduce their exercise levels [p = 0.04]. FACIT scores were lower in patients who had experienced relapses [p = 0.012] and had severe disease [p = 0.011]. Approximately one-third of patients reduced their activity level following IBD diagnosis. CONCLUSIONS: Patients were significantly less physically active after a diagnosis of IBD and this was more apparent in UC. Identification of the risk factors associated with loss of fitness levels would help to address the reduced patient quality of life.

Potential role of soluble angiopoietin-2 and Tie-2 in patients with inflammatory bowel disease.

BACKGROUND: Angiogenesis has been suggested to play an important role in inflammatory bowel disease (IBD). The aim of the study was to evaluate the serum markers of angiogenesis angiopoietin-2 (Ang-2) and soluble angiopoietin receptor Tie-2 in patients with ulcerative colitis (UC) and Crohn's disease (CD). MATERIALS AND METHODS: Serum Ang-2 and Tie-2 serum levels were measured in 160 IBD patients (79 UC and 81 CD) and in 80 matched healthy controls using commercially available enzyme-linked immunosorbent assays. Serum Ang-2 and Tie-2 levels were correlated with the disease activity, as well as the type, localization and treatment of the disease. RESULTS: Median serum Ang-2 and Tie-2 levels were significantly higher in both the UC patients and the CD patients compared with the healthy controls (P < 0.05 and P < 0.001, respectively). The IBD patients with early disease (diagnosis < 2 years) had significantly higher (P = 0.04) median serum Ang-2 levels but significantly lower (P = 0.02) median serum Tie-2 levels as compared with IBD patients with late disease (diagnosis > 2 years). The CD patients with active disease had significantly higher levels of Ang-2 compared with non-active disease (P = 0.02). Serum levels of both Ang-2 and Tie-2 were not correlated with laboratory markers such as ESR, CRP, white blood cell count, platelet count and albumin. CONCLUSIONS: Serum Ang-2 and Tie-2 levels are elevated in patients with IBD. These markers may mediate angiogenesis and vascular permeability in the mucosa of patients with IBD.