Real-world clinical outcomes and healthcare costs in patients with Crohn’s disease treated with vedolizumab versus ustekinumab in the United States

Abstract

Objective

To compare real-world treatment persistence, dose escalation, rates of opportunistic or serious infections, and healthcare costs in patients with Crohn’s disease (CD) receiving vedolizumab (VDZ) vs ustekinumab (UST) in the United States.

Methods

A retrospective observational study in adults with CD initiated on VDZ or UST on/after 26 September 2016, was performed using the IBM Truven Health MarketScan databases (1 January 2009–30 September 2018). Rates of treatment persistence, dose escalation, opportunistic or serious infection–related encounters, and healthcare costs per patient per month (PPPM) were evaluated. Entropy balancing was used to balance patient characteristics between cohorts. Event rates were assessed using weighted Kaplan-Meier analyses and compared between cohorts using log-rank tests. Healthcare costs were compared between cohorts using weighted 2-part models.

Results

589 VDZ and 599 UST patients were included (172 [29.2%] and 117 [19.5%] were bio-naïve, respectively). After weighting, baseline characteristics were comparable between cohorts. No significant difference in rates of treatment persistence (12-month: VDZ, 76.5%; UST, 82.1%; p = .17), dose escalation (12-month: VDZ, 29.3%; UST, 32.7%; p = .97), or opportunistic or serious infection–related encounters were observed between VDZ and UST. Total mean healthcare costs were significantly lower for patients treated with VDZ vs UST (mean cost difference = –$5051 PPPM; p < .01). Findings were consistent in bio-naïve patients.

Conclusions

In this real-world study, similar treatment persistence, dose escalation, and rates of opportunistic or serious infections were observed with VDZ- and UST-treated patients with CD. However, VDZ was associated with a significantly lower cost outlay for healthcare systems.

PLAIN LANGUAGE SUMMARY

Crohn’s disease (CD) causes inflammation in the digestive system. Vedolizumab (VDZ) and ustekinumab (UST) are therapies for patients with CD. Little is known about the clinical outcomes and healthcare costs of VDZ versus UST in the real world in the United States. We used health claims data and found that VDZ and UST had comparable real-world clinical outcomes. After 12 months of treatment, the proportions of patients with CD who stayed on treatment and those who needed to increase therapy dose were similar with VDZ and UST. The rate of infection was also similar between the two groups of patients. However, the monthly healthcare costs were $5051 less for patients treated with VDZ than with UST. This was mainly due to the lower cost of VDZ, which was almost half of that of UST. The lower treatment costs with VDZ may provide substantial savings for the healthcare system and patients specifically. Future cost-effectiveness studies on VDZ and UST are needed to aid treatment selection for patients with CD.

Keywords:

• Biologic therapy
• Crohn’s disease
• healthcare costs
• ustekinumab
• vedolizumab

Transparency

Declaration of funding

This study was supported by Takeda Pharmaceuticals U.S.A., Inc. The study sponsor was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication.

Declaration of financial/other relationships

M. Chiorean has received consulting and/or speaking fees from AbbVie, Arena Pharmaceuticals, Celgene, Janssen, Medtronic, Pfizer, Shire, Takeda, Lilly, BMS, and UCB, and has received educational/research grants from AbbVie, Takeda, Novartis, and Pfizer. J. Jiang, N. Candela, G. Chen, and T. Fan are employees of Takeda Pharmaceuticals U.S.A., Inc., and have stock or stock options. H. Romdhani, D. Latremouille-Viau, S. Shi, R. Bungay, and A. Guerin are employees of Analysis Group, Inc., a consulting company that received funding from Takeda Pharmaceuticals U.S.A., Inc.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors were involved in the conception, design, data acquisition, analyses, and interpretation of the study results; contributed to the drafting of the manuscript; and revised it critically for intellectual content. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

Acknowledgements

Medical writing assistance was provided by Blair Hesp, PhD, CMPP, and Edwin A. Obana, PhD, on behalf of Cadent, a Syneos Health group company, as well as Flora Chik, PhD, of Analysis Group, Inc., and supported by Takeda Pharmaceuticals U.S.A., Inc. Certain data used in this study were supplied by International Business Machines (IBM) Corporation as part of one or more IBM MarketScan Research Databases. Any analysis, interpretation, or conclusion based on these data is solely that of the authors and not IBM Corporation.

Data availability statement

Due to the nature of the research in this study, the supporting data are not available.