Real-World Maintenance Phase Persistence on Ustekinumab and Adalimumab in Ulcerative Colitis

Maryia Zhdanava; Sumesh Kachroo; Aditi Shah; Zhijie Ding; Patrick Lefebvre; Ruizhi Zhao; Caroline Kerner; Dominic Pilon

doi:10.2147/PPA.S446861

Real-World Maintenance Phase Persistence on Ustekinumab and Adalimumab in Ulcerative Colitis

Patient Prefer Adherence. 2024 Apr 10:18:809-820. doi: 10.2147/PPA.S446861. eCollection 2024.

Authors

Maryia Zhdanava¹, Sumesh Kachroo², Aditi Shah¹, Zhijie Ding², Patrick Lefebvre¹, Ruizhi Zhao², Caroline Kerner², Dominic Pilon¹

Affiliations

¹ Analysis Group, Inc, Montréal, QC, Canada.
² Janssen Scientific Affairs, LLC, Horsham, PA, USA.

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.

Keywords: biologics; inflammatory bowel disease; outcomes research.

Grants and funding

This study was sponsored by Janssen Scientific Affairs, LLC. The study sponsor was involved in the study design, interpretation of data, and writing of the manuscript.