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.

scholarly journals Dipeptidyl Peptidase 4 Inhibitors and Risk of Inflammatory Bowel Disease: Real-world Evidence in U.S. Adults

Diabetes Care ◽  
2019 ◽  
Vol 42 (11) ◽  
pp. 2065-2074
Author(s):  
Tiansheng Wang ◽  
Jeff Y. Yang ◽  
John B. Buse ◽  
Virginia Pate ◽  
Huilin Tang ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Real World ◽  
Bowel Disease ◽  
Dipeptidyl Peptidase ◽  
Dipeptidyl Peptidase 4 ◽  
Real World Evidence ◽  
Dipeptidyl Peptidase 4 Inhibitors ◽  
Inflammatory Bowel

scholarly journals Real-world disease activity and sociodemographic, clinical and treatment characteristics of moderate-to-severe inflammatory bowel disease in Brazil

2021 ◽  
Vol 27 (2) ◽  
pp. 208-223
Author(s):  
Cyrla Zaltman ◽  
Rogério Serafim Parra ◽  
Ligia Yukie Sassaki ◽  
Genoile Oliveira Santana ◽  
Maria de Lourdes Abreu Ferrari ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Disease Activity ◽  
Real World ◽  
Bowel Disease ◽  
Treatment Characteristics ◽  
Inflammatory Bowel

scholarly journals DOP19 Real-world healthcare resource utilisation among patients with inflammatory bowel disease administered vedolizumab for 6 months

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S058-S059
Author(s):  
B Cohen ◽  
H Chang ◽  
J R Jason Rogers ◽  
S Garg ◽  
D Lawrence ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
New York ◽  
Real World ◽  
Bowel Disease ◽  
Healthcare Resource ◽  
Medical Center ◽  
Resource Utilisation ◽  
Healthcare Resource Utilisation ◽  
Inflammatory Bowel

Abstract Background Inflammatory bowel disease (IBD) is associated with high healthcare resource utilisation. Vedolizumab (VDZ) is a gut-selective monoclonal antibody that binds the α4β7 integrin and is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). We investigated real-world healthcare resource utilisation for these patients in the 6 months after initiating VDZ treatment. Methods This retrospective, non-interventional, cohort study examined healthcare resource utilisation for adults with IBD treated with VDZ at Mt Sinai Medical Center (New York, NY) between June 1, 2014, and May 31, 2019. IBD-related healthcare resource utilisation (emergency room [ER] visits, hospitalisations, procedures, corticosteroids) and VDZ treatment patterns (induction, persistence, adherence) were assessed for 6 months after first VDZ infusion. Discontinuation was defined as a ≥90-day gap between infusions or stopping VDZ treatment <6 months after the first infusion. Patients who had ≥90-day gaps were not counted as discontinuing if they experienced clinical benefit that continued beyond the 6-month period. Results 880 patients treated with VDZ were assessed. Mean age was 39.6 years; 51.6% of patients were female. 369 (41.9%) and 504 (57.3%) patients were diagnosed with CD and UC, respectively. 81.4% of patients received 3 VDZ induction doses by Day 98; 69.0% received 4 doses by Day 120. The rates of ER visits, hospitalisations and elective surgical or urgent hospitalisations and procedures among VDZ-treated patients were <1 per 100 pt–months. Steroids (oral or IV) were prescribed to 42.2% of patients during the 6-month period. In the 2 months after their last infusion, 81.6% of patients who received ≥3 VDZ doses were steroid-free. Timing of the last infusion was variable. Overall VDZ persistence was 68.0% (65.0% and 70.2% for CD and UC, respectively; Figure). Most patients (67.2%) had ≥80% of days covered in a 180-day period Conclusion At a tertiary IBD centre, VDZ was associated with low healthcare resource utilisation during the first 6 months of treatment. More than two-thirds of patients persisted with treatment, with most being steroid-free at last follow-up.

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