scholarly journals Open access follow-up for inflammatory bowel disease: A pragmatic randomised trial and costeffectiveness study

2000 ◽  
Vol 118 (4) ◽  
pp. A722
Author(s):  
Krishnaraj Ragunath ◽  
John G. Williams ◽  
Wai-Yee Cheung ◽  
Mesbahur M. Rahman ◽  
Ian T. Russell ◽  
...  
Author(s):  
Roxana Mardare ◽  
Natasha Burgess ◽  
Dominic Studart ◽  
Protima Deb ◽  
Marco Gasparetto ◽  
...  

2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte

ObjectivesElectronic health records (EHR) are receiving growing attention from regulators, biopharmaceuticals and payors as a potential source of real-world evidence. However, their suitability for the study of diseases with complex activity measures is unclear. We sought to evaluate the use of EHR data for estimating treatment effectiveness in inflammatory bowel disease (IBD), using tofacitinib as a use case.MethodsRecords from the University of California, San Francisco (6/2012 to 4/2019) were queried to identify tofacitinib-treated IBD patients. Disease activity variables at baseline and follow-up were manually abstracted according to a preregistered protocol. The proportion of patients meeting the endpoints of recent randomised trials in ulcerative colitis (UC) and Crohn’s disease (CD) was assessed.Results86 patients initiated tofacitinib. Baseline characteristics of the real-world and trial cohorts were similar, except for universal failure of tumour necrosis factor inhibitors in the former. 54% (UC) and 62% (CD) of patients had complete capture of disease activity at baseline (month −6 to 0), while only 32% (UC) and 69% (CD) of patients had complete follow-up data (month 2 to 8). Using data imputation, we estimated the proportion achieving the trial primary endpoints as being similar to the published estimates for both UC (16%, p value=0.5) and CD (38%, p-value=0.8).Discussion/ConclusionThis pilot study reproduced trial-based estimates of tofacitinib efficacy despite its use in a different cohort but revealed substantial missingness in routinely collected data. Future work is needed to strengthen EHR data and enable real-world evidence in complex diseases like IBD.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 201-202
Author(s):  
Z Chattha ◽  
R Chattha ◽  
S Reza ◽  
M Moradshahi ◽  
M Fadida ◽  
...  

Abstract Background The relationship between older age and extraintestinal manifestations (EIMs) in patients with inflammatory bowel disease (IBD) remains unknown. Aims This study aims to determine whether older age is associated with increased risk of EIMs in IBD patients. Methods This was a retrospective study of IBD patients seen at the McMaster University Medical Centre, in Hamilton, ON, Canada from 2012–2020. Patients were identified to have the primary outcome of interest if their gastroenterologist documented the presence of any EIM either during the baseline assessment or during the period of follow up. The independent variable, age at start of follow-up, was dichotomized into two categories age >=40 vs. <40.Prior knowledge in combination with forward selection was used to develop a logistic regression model. The variables utilized for the forward selection model included gender, disease duration, and current biologic use. Results A total of 995 IBD patients (625 with CD) were considered for the regression analysis, all for whom the EIM status was recorded. Out of the 995 patients, 270 patients reported at least one EIM – 99 with arthritis/arthralgia, 79 with dermatologic manifestations, 16 with ophthalmic manifestations, 30 with liver manifestations, and 116 with other EIMs. A univariate regression analysis foundincreased odds of EIMs in older patientsas compared to younger patients (odds ratio (OR) 1.41 (95% CI, 1.05 – 1.89)). In the multivariate regression analysis, current biologic use was found to have a significant relationship with odds of having EIMs (OR 1.49; 95% CI, 1.06 – 2.09). After adjustment for biologic use, patients aged 40 or over had 1.46 times higher odds of having EIMs (95% CI 1.03 – 2.05). A sub-analysis of individual EIM categoriesdid not show a significant association with older age. Conclusions Older age is associated with increased risk of EIMs in IBD patients. Patients with EIMs were also more likely to be treated with biological therapies. Clinicians should inquire about the presence of EIMs in older IBD patients. Funding Agencies None


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