https://orcid.org/0000-0003-2380-1495
Abstract
Purpose
To describe real-world persistence in bio-naïve and bio-experienced adults with ulcerative colitis (UC) treated with ustekinumab, a recently approved anti-interleukin 12/23 antibody, or adalimumab, an anti-TNF biologic.
Methods
This is a descriptive, retrospective cohort study. Patients initiating ustekinumab or adalimumab (index date, between 10/21/2019 and 08/13/2021) were selected from the Komodo Health comprehensive dataset and stratified into bio-naïve and bio-experienced subgroups based on biologic use 12 months pre-index date. Endpoints evaluated at 12-months after maintenance phase start using Kaplan–Meier analysis included 1) persistence; 2) persistence while being corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index); and, 3) persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies).
Results
Ustekinumab cohort included 778 patients (236 bio-naïve, 542 bio-experienced) and adalimumab cohort included 1693 patients (1517 bio-naive, 176 bio-experienced). At 12 months after maintenance phase start, 75.5% and 50.5% of bio-naïve patients persisted on ustekinumab and adalimumab and 72.3% and 56.9% of bio-experienced patients persisted on ustekinumab and adalimumab, respectively. Further, 55.1% and 38.2% of bio-naïve patients were persistent and corticosteroid-free with ustekinumab and adalimumab; 43.7% and 33.4% of bio-experienced patients were persistent and corticosteroid-free with ustekinumab and adalimumab, respectively. Moreover, 68.1% and 44.5% of bio-naïve patients were persistent and on monotherapy with ustekinumab and adalimumab; 61.6% and 47.9% of bio-experienced patients were persistent and on monotherapy with ustekinumab and adalimumab, respectively.
Conclusion
At 12 months after maintenance phase start, patients with UC treated with ustekinumab had numerically higher persistence, including persistence while corticosteroid-free and persistence while on monotherapy, than patients treated with adalimumab.
Data Sharing Statement
The data that support the findings of this study were used under license from the Komodo Health. Any researchers interested in obtaining the data used in this study can access the database through Komodo Health, under a license agreement, including the payment of appropriate license fee.
Compliance with Ethics Guidelines
The open-source claims in the database are de-identified and comply with the patient requirements of the Health Insurance Portability and Accountability Act (HIPAA); therefore, institutional review board approval was not required.
Acknowledgments
Medical writing assistance was provided by Christopher Crotty, PhD, an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. Chris Holiday, MA, a former employee of Analysis Group, Inc., contributed to the analysis.
This paper was presented at the Crohn’s & Colitis Congress – January 19-21, 2023, Denver, CO as a poster presentation with interim findings. The poster’s abstract was published in the American Gastroenterological Association’s Gastroenterology journal (DOI: https://doi.org/10.1053/j.gastro.2023.03.086) and in the Inflammatory Bowel Diseases journal (DOI: https://doi.org/10.1093/ibd/izac247.067).
Author Contributions
All authors have made substantial contributions to the conception or design of the study, or the acquisition, analysis, or interpretation of data, drafting the manuscript and revising it critically for important intellectual content, and have provided final approval of this version to be published and agree to be accountable for all aspects of the work.
Disclosure
Sumesh Kachroo, Zhijie Ding, Ruizhi Zhao, and Caroline Kerner are employees of Janssen Scientific Affairs, LLC. and hold stock in Johnson & Johnson. Maryia Zhdanava, Aditi Shah, Patrick Lefebvre, and Dominic Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC. The authors report no other conflicts of interest in this work.