P1205 Long-term treatment patterns, dose escalation, and steroid use among patients with moderate-to-severe ulcerative colitis using advanced therapies: &gt;3 years of continuous follow up using IQVIA PharMetrics Plus database
Authors: Dulai P , Rabbat C , Nason I , Ng S , Yang Y , Hua Y , Kirson N , Fine J 
Published: January 2025

Background

Induction and/or maintenance of remission is seen in less than half of ulcerative colitis (UC) patients with advanced therapies (AT).1,2 This results in frequent switching, dose-optimization, and steroid use to maintain disease control. Long term characterization of these treatment patterns and treatment persistence is needed.

Methods

This retrospective study used the IQVIA PharMetrics® Plus database (2019-2023) to analyze adults in the United States with moderate-to-severe UC who received at least one AT. Baseline characteristics were assessed 6 months prior to AT initiation (index date). Patients were required to have no evidence of other autoimmune diseases at baseline and ≥3 years of continuous follow-up after AT initiation. Switching was defined as filling a prescription for a different AT than was used in the previous line. We further assessed the number of patients who had no claims for an AT following their index treatment (discontinuation), stratified by whether they had ≥1 year of follow-up after discontinuation. Subsequent lines of therapy were similarly examined. Dose escalation was defined as an increase in AT dose or a shortening of prescription intervals, derived from drug label indications and clinical input.

Results

Baseline characteristics and treatment patterns are summarized in Figures 1 and 2. The study included 2,188 patients, with a mean age of 38.6 years, of whom 54% were male. The mean follow-up duration was 46.3 months (median: 45.7 months). Among these patients, 28%, 13%, and 4% had no AT fill for at least one year following their last AT fill in the first, second, and third lines of therapy, respectively. Most patients initially received adalimumab, vedolizumab, or infliximab as their first-line AT, and 42% switched therapies at least once. Vedolizumab was the most common second-line AT. In the third and fourth lines, there was greater variation in AT use, with ustekinumab being the most frequent. Around 25-33% of patients experienced a dose escalation at some point in their treatment line. About 40% of patients had a glucocorticoid (prednisone or budesonide) prescription at the time of switching therapies, with usage increasing in later lines. Among patients with discontinuation, 40% used steroids at time or after discontinuing AT. Among patients with at least one year of follow-up after their last AT fill, 23% used steroids after discontinuing AT.

Conclusion

Advanced therapies for moderate-to-severe UC are associated with high rates of discontinuations, switching and dose escalations. Almost half of all patients completely discontinue AT for ulcerative colitis when followed for 3+ years.

References

1.Afzali A, Lukanova R, Hennessy F, et al. Unmet needs in real-world advanced therapy-naive and -experienced patients with moderately to severely active ulcerative colitis in the United States. Adv Ther. 2023;40(10):4321-4338.

2.Lee SD, LaPensee K, Betts KA, et al. S740 Rates of treatment failure among patients with ulcerative colitis treated with first-line advanced therapies. Am J Gastroenterol. 2021;116:S340