Original ArticleLeveraging Administrative Data to Monitor Rituximab Use in 2875 Patients at 42 Freestanding Children's Hospitals across the United States
Section snippets
Methods
We performed a retrospective cohort study to describe the use of rituximab between 1999 and 2011 in children with a variety of underlying diseases and to evaluate the incidence of hospitalized infections within a 1-year period after the first exposure to rituximab. Children entered the cohort on the first day of the hospital admission on which rituximab billing was first recorded. Patients were then followed for up to 1 year from the day of initial rituximab exposure. Patients who died were
Results
A total of 5 126 861 admissions occurred during the study period of January 1, 1999, to June 31, 2011. We identified 3481 patients from 42 of the 43 PHIS institutions who had a billing code for rituximab. Of these patients, 47 were excluded owing to poor data quality of the rituximab billing date, and 559 were excluded owing to insufficient observation time for the 1-year follow-up. This resulted in a final study population of 2875 patients with 4639 rituximab admissions, and a total of 10 510
Discussion
Rituximab use has increased significantly since 1999. Unexpectedly, there was a significant decline in the rate of rituximab use in 2007. Although the reason for this decline is difficult to determine, it may reflect concerns resulting from published data on rituximab safety. Specifically, the Food and Drug Administration issued a safety report in December 2006 describing 2 fatal cases of PML in adults receiving rituximab for SLE.9 The etiology of PML in these 2 patients remains unknown. In our
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Supported by the National Institutes of Health (1R01 CA133881) and the Slovenian Ministry of Education, Science, Culture, and Sport (grant J3-4220). The authors declare no conflicts of interest.
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Contributed equally.