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Subcutaneously Administered Anti-TNFs for the Treatment of Ulcerative Colitis: A Retrospective, Propensity Score-Matched, US Health Claims Analysis

Advances in Therapy volume 38, pages 4115–4129 (2021)Cite this article

Abstract

Introduction

Adalimumab and golimumab are subcutaneously administered anti-tumor necrosis factor α (TNFα) biologics used in the treatment of ulcerative colitis (UC). To date, no studies have directly compared treatment patterns and healthcare resource utilization (HRU) among patients with UC receiving these therapies in a real-world setting. The objective of this study was to compare these outcomes among patients with UC treated with either adalimumab or golimumab using a US claims database.

Methods

Patients with UC treated with golimumab or adalimumab were identified using the US Optum Clinformatics® Data Mart database. Outcomes of interest included treatment patterns (discontinuations, dose optimizations, persistence, and concomitant medication use) and HRU (outpatient office visits, emergency room [ER] visits, and inpatient stays). Propensity score matching (PSM) was used to account for differences in confounding variables between groups.

Results

Overall, 990 patients were identified (golimumab: n = 277; adalimumab: n = 713). After PSM, 246 patients were included in each group. There were no significant differences between the adalimumab and golimumab groups over the full follow-up period in terms of treatment discontinuations (53.7% vs. 51.2%; P = 0.5881), dose optimizations (35.4% vs. 39.4%; P = 0.3515), or persistence (338.2 vs. 361.2 days; P = 0.4194). During the year after initiating therapy, there were no significant differences in concomitant immunosuppressant (21.9% vs. 21.7%; P = 0.9686) or corticosteroid use (74.7% vs. 78.8%; P = 0.3573) or in HRU outcomes including outpatient office visits (93.3% vs. 94.0%; P = 0.7660), ER visits (15.2% vs. 10.9%; P = 0.2238), and inpatient stays (15.2% vs. 13.6%; P = 0.6680).

Conclusions

In this nationwide PSM cohort study of patients with UC receiving golimumab or adalimumab, no significant differences were observed between groups for treatment patterns or HRU outcomes. High rates of concomitant corticosteroid use, treatment discontinuations, and HRU while on therapy highlight key unmet needs in the treatment of UC.

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Acknowledgements

Funding

This study as well as the journal’s Rapid Service fee were funded by Janssen Inc.

Medical Writing and Editorial Assistance

The authors wish to thank Dr. Ari Mendell, Dana Anger, and Coby Martin of EVERSANA Value and Evidence for their support in the development of this manuscript. This support was funded by Janssen Inc.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authors’ Contributions

Michael J. Stewart, Talat Bessissow, James Gregor, Maureen Hazel, and Bernie Sattin contributed to the conception and design of the study. All authors contributed to the interpretation of data for the study. The first draft of the manuscript was written by Tracy S.H. In, Kinda Karra, and Bernie Sattin with the support of EVERSANA. All authors provided critical revision for important intellectual content. All authors read and approved the final manuscript.

Prior Presentation

The analysis and data reported in this manuscript were previously presented at the following congresses: Stewart et al. Su1874. Presented at the Digestive Disease Week 2019; May 18–21, 2019.

Disclosures

Michael J. Stewart has received research support from AbbVie, Takeda, Janssen, Genentech and Gilead and honoraria from Janssen, Takeda, AbbVie, Pfizer, Amgen and Sandoz. Talat Bessissow has received honoraria and/or grants from AbbVie, BMS, Ferring, Gilead, Janssen, Merck, Pfizer, Roche, Sandoz and Takeda. James Gregor reports participating in advisory boards and receiving research support from Janssen, AbbVie, Takeda and Pfizer. Maureen Hazel is currently an employee of Janssen Inc. Tracy S.H. In is currently an employee of Janssen Inc. Kinda Karra was an employee of Janssen Inc. at the time of manuscript development and is currently an employee of Merck Canada Inc. Dorota Dajnowiec was an employee of Janssen Inc. at the time of manuscript development and is currently an employee of Edwards Lifesciences Corp. Martin Williamson is an employee and shareholder of Janssen Inc. Bernie Sattin is an employee and shareholder of Janssen Inc. EVERSANA is a paid consultant of Janssen and supported in the writing and submission of this manuscript.

Compliance with Ethics Guidelines

Use of the Optum CDM was reviewed by the New England Institutional Review Board (IRB) and was determined to be exempt from broad IRB approval, as this study used appropriately de-identified data without access to personal identifying information.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Author information

Author notes

  1. Kinda Karra

    Present address: Merck Canada Inc., Kirkland, QC, Canada

  2. Dorota Dajnowiec

    Present address: Edwards Lifesciences Corp., Irvine, CA, USA

Authors and Affiliations

  1. Division of Digestive Care and Endoscopy, Department of Medicine, Dalhousie University, Halifax, NS, Canada

    Michael J. Stewart

  2. Division of Gastroenterology, Montreal General Hospital, McGill University Health Centre, Montreal, QC, Canada

    Talat Bessissow

  3. Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada

    James Gregor

  4. Janssen Inc., 19 Green Belt Dr, Toronto, ON, M3C 1L9, Canada

    Maureen Hazel, Tracy S. H. In, Kinda Karra, Dorota Dajnowiec, Martin Williamson & Bernie Sattin

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Correspondence to Bernie Sattin.

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Stewart, M.J., Bessissow, T., Gregor, J. et al. Subcutaneously Administered Anti-TNFs for the Treatment of Ulcerative Colitis: A Retrospective, Propensity Score-Matched, US Health Claims Analysis. Adv Ther 38, 4115–4129 (2021). https://doi.org/10.1007/s12325-021-01818-3

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Keywords

  • Adalimumab
  • Anti-TNFα biologics
  • Golimumab
  • Healthcare resource utilization
  • Propensity score matching
  • Real-world evidence
  • Treatment patterns
  • Ulcerative colitis