Introduction: Among patients with ulcerative colitis (UC), treatment with immunomodulators, 5-ASA (5-aminosalicylic acid), and corticosteroids while receiving biologic agents is common. However, real-world information on non-biologic medication use among UC patients initiated on ustekinumab is limited. This study compared non-biologic medication use pre- and post-ustekinumab initiation among UC patients.
Methods: Adults with UC initiated on ustekinumab (index date) between 10/18/2019 (FDA approval of ustekinumab for UC) and 10/31/2020 were selected from the de-identified health insurance claims Symphony Health Solutions’ Patient Transactional Datasets. Patients were excluded if they had a claim for Crohn’s disease anytime or for other autoimmune diseases pre-index. Patients were required to have: ≥1 claim for UC in the 12 months pre-index period (baseline), ≥2 ustekinumab claims within 90 days of the index date, and ≥6 months of follow-up. Non-biologic agent use in the 6 months period before and after the initiation of ustekinumab was compared with a logistic model estimated by generalized estimating equation. Results were reported as odds ratio with 95% confidence interval and p-values.
Results: A total of 760 patients with UC were initiated on ustekinumab and selected for the study (age 44.6 years old; 48.9% female; baseline biologic use 52.1% [potentially underestimated given the database open nature]; Quan-Charlson comorbidity index 0.62). The likelihood of immunomodulator and 5-ASA use decreased by 22% and 46%, after ustekinumab initiation (all P< 0.05). Similarly, patients were 52% less likely to use any corticosteroids and 34% less likely to use corticosteroids for ≥60 days (all P< 0.05). Further, there was no significant changes observed for the use of opioids (18.9% vs. 17.4%) or the use of anti-diarrheals (5.9% vs. 6.1%), and patients were 29% less likely to use GI antispasmodics after ustekinumab initiation (P< 0.05; Table 1). In a descriptive analysis, corticosteroids use numerically decreased at each month post-ustekinumab from 25.4% during the first 30 days following the index date compared to 17.4% within 150-180 days post-ustekinumab (Figure 1).
Discussion: In this real-world study of patients with UC, initiating ustekinumab was associated with a significant decrease in the use of immunomodulators, 5-ASA, and corticosteroids. Longer-term data are necessary to better understand non-biologic medication use after biologic initiation and inform treatment choice for patients with UC.
