Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

2019 ◽  
Author(s):  
Shahnaz Khan ◽  
Ewa Rupniewska ◽  
Mackenzie Neighbors ◽  
David Singer ◽  
Joseph Chiarappa ◽  
...  
Keyword(s):  
United States ◽  
Systematic Review ◽  
Inflammatory Bowel Disease ◽  
Dose Escalation ◽  
Real World ◽  
Bowel Disease ◽  
The United States ◽  
Real World Evidence ◽  
Inflammatory Bowel

scholarly journals Utility of routinely collected electronic health records data to support effectiveness evaluations in inflammatory bowel disease: a pilot study of tofacitinib

2021 ◽  
Vol 28 (1) ◽  
pp. e100337
Author(s):  
Vivek Ashok Rudrapatna ◽  
Benjamin Scott Glicksberg ◽  
Atul Janardhan Butte
Keyword(s):  
Inflammatory Bowel Disease ◽  
Pilot Study ◽  
Disease Activity ◽  
Real World ◽  
Bowel Disease ◽  
P Value ◽  
Health Records ◽  
Real World Evidence ◽  
Inflammatory Bowel

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.

P140 CURRENT STATUS OF HOME INFUSIONS FOR INFLAMMATORY BOWEL DISEASE IN THE UNITED STATES

2018 ◽  
Vol 154 (1) ◽  
pp. S72-S73 ◽  
Author(s):  
Bharati Kochar ◽  
Yue Jiang ◽  
Christopher F. Martin ◽  
Edward L. Barnes ◽  
Millie D. Long
Keyword(s):  
United States ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
The United States ◽  
Current Status ◽  
Inflammatory Bowel

scholarly journals In-hospital outcomes of inflammatory bowel disease in cannabis users: a nationwide propensity-matched analysis in the United States

2019 ◽  
Vol 7 (12) ◽  
pp. 252-252 ◽  
Author(s):  
Rupak Desai ◽  
Upenkumar Patel ◽  
Hemant Goyal ◽  
Afrina Hossain Rimu ◽  
Dipen Zalavadia ◽  
...  
Keyword(s):  
United States ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
The United States ◽  
Hospital Outcomes ◽  
Inflammatory Bowel
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