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Abstract

Background

The ECCO CD guidelines1 comment that some studies have found 5-ASA to be an effective treatment for mild CD, whilst others report a more marginal benefit. In order to further address the ECCO Statement in the medical management of patients with mild CD, three European healthcare databases are being investigated to understand the clinical treatment patterns of 5-ASA use in patients with mild CD. The objective is to provide RWE on clinical outcomes and healthcare resource utilisation for patients with mild CD treated with 5-ASA.

Methods

The ‘Clinical and treatment Resource use, patient Outcomes and Health impact using National prescribing Systems’ (‘CROHN’S’) Investigation is an observational, retrospective, longitudinal study using 3 healthcare databases: (1) Clinical Practise Research Datalink (CPRD), UK; (2) PHARMO Database Network, The Netherlands; and (3) Swedish Inflammatory Bowel Disease Registry (SWIBREG). CPRD contains data on >5 million patients (8% of population) and the PHARMO Database Network covers >4 million patients (25% of population). SWIBREG is a disease-specific registry with data on ~40000 IBD patients (68% of Swedish IBD patients). From these databases, adult (≥18 years) patients with a diagnosis of CD being treated with 5-ASA were identified over a period from 2006 to 2017. Patients were followed from first 5-ASA prescription (index event) until the last date of data collection available within the database.

Results

Feasibility analysis confirmed the availability and accessibility of data within the three databases to answer the study objective. This identified 15013 CD patients in PHARMO and 14438 in SWIBREG, while CPRD included 1 888 064 5-ASA prescriptions. Preliminary analysis identified 21455 CD patients receiving 5-ASA: 12476 in CPRD, 5805 in PHARMO, and 3174 in SWIBREG. All relevant data on these patients were extracted for analysis, including information on: 5-ASA use, disease activity, and healthcare utilisation. This included 5-ASA treatment continuation rates, dosing changes, use of adjunctive therapies, treatment switches, primary care visits, hospital visits (e.g. consultations, admissions, surgery), and costings of all healthcare usage during the entire follow-up period.

Conclusions

The analysis of these three healthcare databases, both individually and in aggregate, will provide large scale, RWE on clinical outcomes and healthcare resource utilisation in patients with mild CD treated with 5-ASA.

Reference

1. Gomollón. J Crohns Colitis 2017;11:3–25.

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Copyright © 2018 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]
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03. Poster presentations > c. Clinical: Therapy and observation
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