Background: The impact of pregnancy on levels of biologic agents in patients with IBD is undefined and time to elimination in vedolizumab-exposed infants is unknown. Aims: To determine the effect of pregnancy on infliximab, adalimumab and vedolizumab levels and to study infant vedolizumab clearance Methods: In a prospective observational study, maternal drug levels were measured pre-conception, in each trimester, at delivery and postpartum. The association between drug levels and gestation in weeks was assessed using generalised estimating equation modelling. Infant vedolizumab levels were performed at birth (cord blood), 6 weeks and 3 months or until undetectable. Results: We included 50 IBD patients (23 on infliximab, 15 on adalimumab and 12 on vedolizumab) with at least two intrapartum observations, plus 5 patients on vedolizumab with only mother and baby samples at delivery. Modelling showed no change in adalimumab levels, an increase in infliximab levels of 0.16 (95% CI 0.08-0.24) µg/L/week (P < 0.001) and a decrease of 0.18 (95% CI: −0.33 to −0.02) µg/L/week (P = 0.03) for vedolizumab. In 17 mother-baby pairs, median infant vedolizumab levels at birth were lower than maternal levels (P < 0.05) with an infant:maternal ratio of 0.7 (IQR 0.5-0.9). Vedolizumab was undetectable between 15 and 16 weeks of age in all 12 infants completing follow-up testing. Conclusions: During pregnancy, adalimumab levels remain stable, while infliximab levels increase and vedolizumab levels decrease. However, the increments were small suggesting that intrapartum therapeutic drug monitoring and dose adjustment are not indicated. Unlike infliximab and adalimumab, infant vedolizumab levels are lower in cord blood than in mothers and appear to clear rapidly.
Background To evaluate the long‐term efficacy and safety of continued repeated low‐level red‐light (RLRL) therapy on myopia control over 2 years, and the potential rebound effect after treatment cessation. Methods The Chinese myopic children who originally completed the one‐year randomised controlled trial were enrolled. Children continued RLRL‐therapy were defined as RLRL‐RLRL group, while those who stopped and switched to single‐vision spectacle (SVS) in the second year were RLRL‐SVS group. Likewise, those who continued to merely wear SVS or received additional RLRL‐therapy were SVS‐SVS and SVS‐RLRL groups, respectively. RLRL‐therapy was provided by an at‐home desktop light device emitting red‐light of 650 nm and was administered for 3 min at a time, twice a day and 5 days per week. Changes in axial length (AL) and cycloplegic spherical equivalence refraction (SER) were measured. Results Among the 199 children who were eligible, 138 (69.3%) children attended the examination and 114 (57.3%) were analysed (SVS‐SVS: n = 41; SVS‐RLRL: n = 10; RLRL‐SVS: n = 52; RLRL‐RLRL: n = 11). The baseline characteristics were balanced among four groups. In the second year, the mean changes in AL were 0.28 ± 0.14 mm, 0.05 ± 0.24 mm, 0.42 ± 0.20 mm and 0.12 ± 0.16 mm in SVS‐SVS, SVS‐RLRL, RLRL‐SVS and RLRL‐RLRL group, respectively (p < 0.001). The respective mean SER changes were −0.54 ± 0.39D, −0.09 ± 0.55D, −0.91 ± 0.48D, and −0.20 ± 0.56D (p < 0.001). Over the 2‐year period, axial elongation and SER progression were smallest in RLRL‐RLRL group (AL: 0.16 ± 0.37 mm; SER: −0.31 ± 0.79D), followed by SVS‐RLRL (AL: 0.44 ± 0.37 mm; SER: −0.96 ± 0.70D), RLRL‐SVS (AL: 0.50 ± 0.28 mm; SER: −1.07 ± 0.69D) and SVS‐SVS group (AL: 0.64 ± 0.29 mm; SER: −1.24 ± 0.63D). No self‐reported adverse events, functional or structural damages were noted. Conclusions Continued RLRL therapy sustained promising efficacy and safety in slowing myopia progression over 2 years. A modest rebound effect was noted after treatment cessation.
Objective: To examine the effect of homelessness on mortality. Methods: This 15-year retrospective longitudinal cohort study compared mortality outcomes of homeless and non-homeless adults attending the emergency department of an innercity public hospital in Melbourne, Victoria between 1 January 2003 and 31 December 2004. Homeless individuals had ≥1 recorded episodes of homelessness within the recruitment period, categorised by type: primary, secondary, tertiary, marginally housed. Non-homeless individuals were stably housed throughout. Results: Over 15 years, homeless individuals had a higher mortality rate (11.89 vs. 8.10 per 1,000 person-years), significantly increased mortality risk (rate ratio 1.47, 95% confidence interval [CI] 1.26-1.71) and younger median age at death (66.60 vs. 78.19 years) compared to non-homeless individuals. Using adjusted Cox proportional hazards models, primary (hazard ratio [HR] 2.05, 95%CI 1.67-2.50), secondary (HR 1.60, 95%CI 1.23-2.10) and tertiary (HR 1.72, 95%CI 1.16-2.56) homelessness were independent risk factors for premature mortality. Conclusion: At least one recorded episode of primary, secondary, or tertiary homelessness was associated with premature mortality and younger age at death over a 15-year period. Implications for public health: Accurately identifying individuals experiencing primary, secondary or tertiary homelessness at the emergency department may enable targeted interventions that could potentially reduce their risk of premature mortality.
Background and Aims Inflammatory bowel disease [IBD] affects women during their childbearing years. Gastrointestinal ultrasonography [GIUS] accurately identifies disease activity in non-pregnant patients with IBD. The utility of GIUS in pregnancy has not been established. We aimed to determine the feasibility and accuracy of GIUS in the assessment of IBD during pregnancy progression. Methods A multicentre observational study of women with IBD undergoing GIUS during pregnancy. Clinicians assessed the adequacy of bowel views and disease activity in four colonic segments and the terminal ileum. Location[s] in which views were impeded by the uterus were documented. GIUS disease activity [bowel wall thickness >3 mm] was compared with biochemical disease activity [faecal calprotectin >100 μg/g]. Results Ninety patients and 127 GIUS examinations were included [median gestation 19 weeks, range 4–33]. Adequate colonic views were obtained in 116/127 [91%] scans. Adequate ileal views were obtained in 62/67 [93%] scans <20 weeks and 30/51 [59%] scans at 20–26 weeks. There was a positive correlation between bowel wall thickness and calprotectin [r = 0.26, p = 0.03]. GIUS delivered a specificity of 83%, sensitivity of 74%, and negative predictive value of 90% compared with calprotectin. Conclusions GIUS is a feasible and accurate modality for monitoring IBD in pregnancy. Adequate GIUS views of the colon and terminal ileum can be obtained in the majority of patients up to 20 weeks of gestation. Beyond 20 weeks, GIUS provides good views of the colon but the terminal ileum becomes difficult to assess.
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