Analysis of Nintedanib Dosing and Mortality in US Medicare Data

<bold>Introduction:</bold> Nintedanib has been shown to reduce mortality in Idiopathic Pulmonary Fibrosis (IPF) (T Dempsey, Eur Respir J 2023; 62: 2301299). Randomized trials support use of Nintedanib at 150 mg twice daily. Unfortunately, due to gastrointestinal effects the dosage is often reduced to 100 mg twice daily, despite lack of information comparing the doses. To our knowledge, there have been no evaluation of dose and outcomes of Nintedanib using Medicare data to compare patients receiving 150 mg twice daily versus the reduced dose of 100 mg twice daily. <bold>Objectives:</bold> To address this, we analyzed Medicare Fee for Service data to identify patients with IPF treated with Nintedanib at 150 mg twice daily versus 100 mg twice daily and compared mortality rates. <bold>Methods:</bold> A final 1:1 propensity score-matched cohort of 1,813 individuals in each dosing group was identified in the US Medicare data. Covariates used for propensity matching included age, sex, race/ethnicity, insurance type, other medication use, oxygen use, smoking, healthcare utilization and comorbidities. Clinical outcomes for the analysis included all-cause mortality (primary) and hospitalizations (secondary) measures. <bold>Results:</bold> Interestingly, the mortality outcomes were not significantly different between the two treatment doses (Hazard Ratio [HR] 0.74; 95% confidence interval [CI], 0.54 to 1.01, p = 0.058). In addition, hospitalization risk was also not different between the doses (HR 0.89; 95% CI 0.78-1.02, p = 0.1). <bold>Conclusion:</bold> In Medicare Fee for Service claims data, patients with IPF receiving nintedanib at the reduced 100 mg twice daily dose had similar outcomes of mortality and hospitalization compared to individuals treated with 150 mg twice daily.