Damemarie Paul, MPH1, Xiaoyu Nie, PhD2, Manasvi Sundar, MPH2, Keith A. Betts, PhD2, Sara N. Horst, MD3 1Bristol Myers Squibb, Princeton, NJ; 2Analysis Group, Inc., Los Angeles, CA; 3Vanderbilt Inflammatory Bowel Disease Clinic, Nashville, TN
Introduction: Long-term use of corticosteroid (CS) therapy is associated with a high risk of relapse and side effects in patients (pts) with ulcerative colitis (UC). Ozanimod (OZA), a once-daily oral advanced therapy (AT) approved for the treatment of moderate to severe UC, has shown durable efficacy (including CS-free remission) and long-term safety. This study used real-world data to describe pre-OZA initiation treatment history and CS overuse, as well as CS sparing after OZA initiation.
Methods: This retrospective study used IQVIA PharMetrics® Plus data from January 2011 to September 2023. Adult pts with UC were included if they initiated OZA on or after May 27, 2021 (index). CS overuse was defined as continuous use of CS for >90 days or ≥2 episodes of CS use in ≤1 year based on the prescription history pre-index. Proportions of days covered (PDCs) by CS in the 6 months pre-index (baseline) and the follow-up period were estimated. Proportions of pts remaining CS-free post-index were estimated using Kaplan-Meier analysis.
Results: In all, 245 pts receiving OZA were included (median age: 42.0 years; 60.4% male; 155 (63.3%) pts overused CS prior to OZA initiation). Pts who overused CS were older (median age 44.0 vs 38.0 years) and had longer median time (interquartile range [IQR]) from UC diagnosis to index (30.9 [17.3–53.4] vs 9.8 [5.2–19.1] months) compared to those who did not overuse CS. The median time (IQR) for CS overuse pre-index was 7.4 (3.9–12.0) months. The median (IQR) follow-up time was 7.9 (4.7–14.1) months from index for pts who overused CS and 5.8 (3.4–10.7) months for pts who did not overuse CS. More pts who overused CS received AT pre-index compared to those who did not (68.4% vs 33.3%). Vedolizumab and adalimumab were the most frequently used ATs. The mean PDC from baseline to follow-up was reduced by 40.9% (23.5% vs 13.9%, respectively). The PDC reduction was 41.8% in pts who overused and 38.4% in pts who did not overuse CS. At 3 months post-index, 59.0% of all pts were CS-free, including 50.4% of pts who overused and 74.4% of pts who did not overuse CS. At 6 months post-index, 50.3% of all pts were CS-free, including 43.9% of pts who overused and 60.9% of pts did not overuse CS.
Discussion: After OZA initiation, pts experienced substantial reductions in CS use, and a large proportion of pts with UC remained CS-free at 6 months. This suggests that pts initiating OZA may experience additional health benefits via CS sparing.
Damemarie Paul, MPH1, Xiaoyu Nie, PhD2, Manasvi Sundar, MPH2, Keith A. Betts, PhD2, Sara N. Horst, MD3. P0880 - Real-World Retrospective Analysis of Ozanimod and Associated Corticosteroid Sparing for the Treatment of Ulcerative Colitis, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
