1. Real-World Maintenance Phase Persistence on Ustekinumab and Adalimumab in Ulcerative Colitis
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Zhdanava M, Kachroo S, Shah A, Ding Z, Lefebvre P, Zhao R, Kerner C, and Pilon D
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biologics ,inflammatory bowel disease ,outcomes research ,Medicine (General) ,R5-920 - Abstract
Maryia Zhdanava,1 Sumesh Kachroo,2 Aditi Shah,1 Zhijie Ding,2 Patrick Lefebvre,1 Ruizhi Zhao,2 Caroline Kerner,2 Dominic Pilon1 1Analysis Group, Inc, Montréal, QC, Canada; 2Janssen Scientific Affairs, LLC, Horsham, PA, USACorrespondence: Maryia Zhdanava, Analysis Group, Inc, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada, Tel +1-514-394-4469, Fax +1-514-394-4461, Email Masha.Zhdanava@analysisgroup.comPurpose: 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
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- 2024