Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation

Background/Aims@#Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ. @*Methods@#In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs. @*Results@#A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67). @*Conclusions@#VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

Determining the risk of developing symptomatic covid-19 infection after attending hospital for radiological examinations: controlled cohort study

OBJECTIVETo determine whether brief attendance for outpatient radiological investigations is associated with increased risk of clinically significant coronavirus disease 2019 (covid-19) infection. DESIGNObservational cohort study with a historical control. SETTING2 large UK University Hospitals located in Nottingham and Cardiff. PARTICIPANTSAll 47,340 patients who attended an outpatient radiology appointment at Nottingham University Hospitals and University Hospital of Wales during the first wave of the pandemic in 2020, and 70,655 patients that comprised the control cohort who attended for outpatient radiology the same period in 2019. MAIN OUTCOME MEASURESThe risk of developing clinically significant covid-19 infection within 28-days of attending a radiological examination. Covid-19 infection rates for the 2020 cohort were compared against a control group who attended in 2019. RESULTS84 positive SARS-CoV-2 tests were temporally associated with 47,340 radiological examinations across two hospitals in 2020. This low infection rate was higher than the 2019 control cohort; OR 2.507 (1.766 - 3.559) and equates to an approximate 1 positive covid-19 infection per 1000 radiology investigations. CONCLUSIONSOur data suggests that attending hospitals for outpatient radiological investigations during the pandemic is associated with a very small absolute risk of acquiring clinically significant covid-19 infection. It is unlikely that this risk is directly attributable to radiology attendance, considering the reasons leading individuals to attend hospitals during the pandemic, the true attributable risk will likely be even lower. TRIAL REGISTRATIONClinicalTrials.gov NCT04544176