Objectives To better understand the real-world impact of biologic therapy in persons with Crohn’s disease (CD) and ulcerative colitis (UC), we evaluated the effect of marketplace introduction of infliximab on the population rates of hospitalisations and surgeries and public payer drug costs.
Design We used health administrative data to study adult persons with CD and UC living in Ontario, Canada between 1995 and 2012. We used an interrupted time series design with segmented regression analysis to evaluate the impact of infliximab introduction on the rates of IBD-related hospitalisations, intestinal resections and public payer drug costs over 10 years among patients with CD and 5 years among patients with UC, allowing for a 1-year transition.
Results Relative to what would have been expected in the absence of infliximab, marketplace introduction of infliximab did not produce significant declines in the rates of CD-related hospitalisations (OR at the last observation quarter 1.06, 95% CI 0.811 to 1.39) or intestinal resections (OR 1.10, 95% CI 0.810 to 1.50), or in the rates of UC-related hospitalisations (OR 1.22, 95% CI 1.07 to 1.39) or colectomies (OR 0.933, 95% CI 0.54 to 1.61). The findings were similar among infliximab users, except that hospitalisation rates declined substantially among UC patients following marketplace introduction of infliximab (OR 0.515, 95% CI 0.342 to 0.777). There was a threefold rise over expected trends in public payer drug cost among patients with CD following infliximab introduction (OR 2.98,95% CI 2.29 to 3.86), suggesting robust market penetration in this group, but no significant change among patients with UC (OR 1.06, 95% CI 0.955 to 1.18).
Conclusions Marketplace introduction of infliximab has not yielded anticipated reductions in the population rates of IBD-related hospitalisations or intestinal resections, despite robust market penetration among patients with CD. Misguided use of infliximab in CD patients and underuse of infliximab in UC patients may largely explain our study findings.
- inflammatory bowel disease
- crohn’s disease
- ulcerative colitis
- surgery for Ibd
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Contributors All coauthors made substantial contributions to study design, data interpretation and critical revision of the manuscript for important intellectual content. SKM was most responsible for all aspects of the study, including drafting and finalising the manuscript and all requested revisions. JB was responsible for data acquisition and statistical programming. MT was responsible for guiding the statistical analysis.
Funding This study was funded by the Department of Medicine, University of Ottawa and the Canadian Institutes of Health Research (Project Grant # 162393). This study was supported by IC/ES, which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC).
Disclaimer The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources. Parts of this paper are based on data and information provided by the Canadian Institute for Health Information (CIHI). No endorsement by ICES, MOHLTC or CIHI is intended or should be inferred.
Competing interests COI Statement: SKM has received honoraria for speaking or consultancy from AbbVie, Janssen, Takeda, Pfizer, Shire and Ferring. JB has no conflicts of interest. EIB has no conflicts of interest. CNB has served on advisory boards of AbbVie Canada, Ferring Canada, Janssen Canada, Napo Pharmaceuticals, Pfizer Canada, Shire Canada, Takeda Canada, and has consulted to 4D Pharma and Mylan Pharmaceuticals. He has received unrestricted educational grants from AbbVie Canada, Janssen Canada, Shire Canada and Takeda Canada. He has been on speaker’s bureau of Ferring Canada and Shire Canada. GG has received honoraria for speaking or consultancy from AbbVie, Janssen, Pfizer and Takeda, and research support from Janssen, AbbVie, GlaxoSmithKline, Merck and Shire. He shares ownership of a patent: Treatment ofInflammatory Disorders, Autoimmune Disease and PBC . UTI Limited Partnership, assignee, Patent 62/555,397, 7 September 2017. JDMcC has received honoraria for speaking or consultancy from AbbVie, Janssen, Takeda, Pfizer, Shire and Ferring. HS has served on advisory boards of Ferring Canada, Takeda Canada, Merck Canada and received research funding from Merck Canada. LT has received research funding from Janssen Canada, and served on advisory boards for AbbVie Canada, Takeda Canada, Merck Canada, Pfizer Canada and Mallinckrodt USA.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The dataset from this study is held securely in coded form at ICES. While data sharing agreements prohibit ICES from making the dataset publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at http://www.ices.on.ca/DAS. The full dataset creation plan and underlying analytic code are available from the authors on request, understanding that the computer programs may rely on coding templates or macros that are unique to ICES and are therefore either inaccessible or may require modification.
Correction notice This article has been corrected since it published Online First. The disclaimer statement, figure 2 legend and significance of this study box has been updated.
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