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|Title||Leveraging administrative data to monitor rituximab use in 2875 patients at 42 freestanding children's hospitals across the United States.|
|Publication Type||Journal Article|
|Year of Publication||2013|
|Authors||Kavcic M, Fisher BT, Seif AE, Li Y, Huang YS, Walker D, Aplenc R|
|Keywords||Adolescent, Antibodies, Monoclonal, Murine-Derived, Child, Child, Preschool, Cohort Studies, Drug Utilization, Female, Hospitals, Pediatric, Humans, International Classification of Diseases, Male, Retrospective Studies, Sepsis, Treatment Outcome, United States|
OBJECTIVE: To describe the pharmacoepidemiology of rituximab use in children and to estimate the frequency of infectious events within a 1-year period after rituximab exposure.
STUDY DESIGN: This is a retrospective cohort study of patients who received rituximab at 1 of 42 children's hospitals contributing data to the Pediatric Health Information System between January 1999 and June 2011. International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) discharge diagnosis codes were analyzed to categorize underlying diseases (hematologic malignancies, primary immunodeficiencies, autoimmune diseases, and transplant recipients) and to estimate inpatient infectious complication rates within each category.
RESULTS: A total of 2875 patients with 4639 rituximab admissions were identified. The median age at index admission was 11 years (IQR, 5-15 years). The rate of rituximab admissions increased from 3 to 185 per 100,000 admissions per year over the study interval. During the 1-year follow-up period, 463 patients (16%) died. Infectious events were assessed in 2246 of the rituximab-exposed patients; 6.1% were diagnosed with sepsis and 2.0% with septic shock. The frequency of sepsis ranged from 2.4% in patients with autoimmune diseases to 12.2% in those with primary immunodeficiencies. Three patients were assigned an ICD-9-CM discharge diagnosis code for Pneumocystis joroveci pneumonia, 1 patient was assigned an ICD-9-CM discharge diagnosis code for hepatitis B, and 1 patient was assigned an ICD-9-CM discharge diagnosis code for progressive multifocal leukoencephalopathy.
CONCLUSION: The use of rituximab has increased significantly in children with a variety of underlying diseases. Based on ICD-9-CM code data, the rates of sepsis and other life-threatening infections after rituximab exposure vary depending on the underlying condition. Based on surveillance of infection using ICD-9-CM diagnosis codes, the rates of opportunistic infections appear to be low.
|Alternate Journal||J. Pediatr.|
|PubMed Central ID||PMC3909336|
|Grant List||1R01 CA133881 / CA / NCI NIH HHS / United States |
P30 CA016520 / CA / NCI NIH HHS / United States
R01 CA133881 / CA / NCI NIH HHS / United States