Background: Ozanimod, a once-daily oral medication, is the first sphingosine 1-phosphate receptor modulator approved for adults with moderately to severely active ulcerative colitis (UC). An electrocardiogram is needed to determine whether conduction abnormalities are present prior to treatment initiation. Contraindications to ozanimod use that may be identified with an electrocardiogram include presence of Mobitz type II second-degree or third-degree (complete) atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker. This analysis used MarketScan Commercial claims data to estimate the real-world prevalence of select cardiac conduction disorders among adult patients with UC in the US. Methods: Data from October 1, 2016 to September 30, 2021 were obtained for adult patients with ≥2 UC diagnostic claims within 12 months and continuous medical enrollment of 12 months before the index date. The prevalence of an ICD-10-CM diagnosis code for second-degree (I44.1) or complete AV block (I44.2), sick sinus syndrome (I49.5), or sino-atrial block (I45.5) was analyzed. Prevalence rates were stratified by patient demographics, use of heart rate–lowering medications (anti-arrhythmics, beta blockers, calcium channel blockers, disopyramide, or ivabradine), or an implanted pacemaker use. Sensitivity analyses identified cardiac conduction disorders within the pre-index period and in a US claims database (IQVIA PharMetrics Plus). Descriptive analyses are reported. Results: In total, 79,832 patients with UC met the inclusion criteria; 52.5% were female and mean (SD) age was 45.8 (13.1) years. Of all patients, 29 (0.04%) had second-degree AV block, 41 (0.05%) had complete AV block, 145 (0.18%) had sick sinus syndrome, and 12 (0.02%) had sino-atrial block. The prevalence rate of all the selected cardiac conduction disorders for patients aged ≥50 years old (n = 35,912; 0.05%, 0.09%, 0.32%, and 0.03%, respectively) was numerically higher than for patients aged <50 years old (n = 43,920; 0.03%, 0.02%, 0.07%, and 0.01%, respectively). The prevalence rate for those using heart rate–lowering medications (n = 15,468; 0.08%, 0.17%, 0.52%, and 0.03%, respectively) was numerically higher than for patients without heart-rate-lowering medications (n = 64,364; 0.02%, 0.02%, 0.10%, and 0.01%, respectively). Among patients without implanted pacemaker use (n = 79,607), the prevalence rate was 0.02%, 0.02%, 0.11%, and 0.01%, respectively. Prevalence rates observed in sensitivity analyses were similar to those observed in the main analysis. Conclusion(s): Overall, the proportion of patients with cardiac conduction disorders was less than 0.2% in this real-world commercial claims sample of 79,832 adult patients with UC in the US. The prevalence remained less than 0.6% in high-risk populations including patients aged ≥50 old and those receiving heart rate–lowering medications. Though these data may be subject to miscoding (especially overcoding for sick sinus syndrome) given the claims nature of the data source, they highlight the extremely low prevalence of select cardiac condition disorders that may be identified by using an electrocardiogram in patients with UC.
Read full abstract