PHP118 - Incidence of Malignant Neoplasm for Patients Using Biologic Drugs: A Nested Case-Control Study Using Medicare 5% Sample Datasets

Abstract

Biologic drugs have been changing the clinical management of various diseases such as cancer and autoimmune diseases. Although biologic drugs are expected to play critical roles, their association with the development of malignant neoplasms (MN) remains unclear. We examined the relationship between prescription of biologic drugs and incidence of MN based on a claims database analysis. We performed a nested case-control study using Medicare 5% Sample data (2011-2016). Among the insureds with full exposure in 2011, those with neither diagnosis with MN nor prescription of biologic drugs in 2011 were extracted. Cases were individuals having diagnosis of MN in 2012 or later. Controls were selected from the extracted patients without diagnosis of MN, and matched with the cases by sex, age, and end of the eligible period. Within the period from January 1, 2012 to the day before earliest diagnosis of MN in cases, percentage of individuals being prescribed biologic drugs was calculated for both cases and their matched controls. Among 675,922 individuals extracted from the dataset, 283,198 cases were identified. Matched individuals analyzed in this study were 277,638 (55.3% were female, average ± standard deviation age was 72.8 ± 8.6) in each group. Percentage of individuals being prescribed biologic drug was significantly higher (p<0.0001) in cases, 1.17%, than in controls, 0.91%. Exudative senile macular degeneration was the most common diagnosis given to patients on the day of biologic drug prescription, followed by senile osteoporosis, osteoporosis, unspecified, rheumatoid arthritis, and venous tributary occlusion. Our result suggests association between taking biologic drugs and development of MN. Due to the difficulty to conduct a RCT, this result could be important by furnishing one source of circumstantial evidence. Detailed real-world data analyses considering the type of MN and the duration of the treatment by biologic drugs should be conducted.