Association of RSV-related hospitalization and non-compliance with palivizumab among commercially insured infants: a retrospective claims analysis.

Dan L Stewart,Brett Pinsky,Michael Frogel,Kellie J Ryan,Laura Becker,Jerry G Seare

doi:10.1186/1471-2334-13-334

Abstract

BackgroundPalivizumab has been shown to decrease the incidence of hospitalization due to respiratory syncytial virus (RSV) in infants at risk of severe RSV disease. We examined the association between compliance with palivizumab dosing throughout the RSV season and risk of RSV-related hospitalization in clinical practice.MethodsSubjects who were born and discharged from the hospital before the RSV season and received ≥1 palivizumab dose during their first RSV season were identified from a large US commercial health insurance database between 01/01/03 and 12/31/09. Subjects were deemed compliant if they received ≥5 palivizumab doses without gaps (>35 days) and their first dose was received by November 30. RSV-related hospitalizations were identified using ICD-9-CM diagnosis codes and examined over 2 observation periods: post-index dose and RSV season. A Cox proportional hazard model was used to evaluate the association between non-compliance and RSV-related hospitalization.ResultsOf the 5,003 subjects who received palivizumab, 62% were deemed non-compliant. Non-compliant subjects had significantly higher unadjusted rates of RSV-related hospitalizations compared to compliant subjects during both observation periods (post-index: 6.1 vs. 2.8 per 100 infant seasons, p < 0.001; RSV season: 5.9% vs. 2.3%; p < 0.001). In multivariate analyses, non-compliance was significantly associated with higher risk of RSV-related hospitalization (HR = 2.01; p < 0.001). Of the 225 RSV-related hospitalizations observed during the RSV season, 61 (27%) occurred before the first dose of palivizumab.ConclusionsSubjects who did not receive monthly dosing of palivizumab throughout the RSV season had significantly higher rates of RSV-related hospitalizations. The RSV-related hospitalizations prior to the first dose of palivizumab suggest some dosing was started too late.

Highlights

Palivizumab has been shown to decrease the incidence of hospitalization due to respiratory syncytial virus (RSV) in infants at risk of severe RSV disease
Palivizumab is a humanized murine monoclonal antibody that is approved by the US Food and Drug Administration (FDA) for the prevention of severe respiratory tract disease caused by RSV in children with BPD, infants with a history of premature birth (≤35 wGA), and children with hemodynamically significant congenital heart disease (CHD)
In order to address the potential issues related to the variable exposure/follow-up, we looked at RSV hospitalizations for a uniform observation period (October 1 to April 30)

Summary

Introduction

Palivizumab has been shown to decrease the incidence of hospitalization due to respiratory syncytial virus (RSV) in infants at risk of severe RSV disease. We examined the association between compliance with palivizumab dosing throughout the RSV season and risk of RSV-related hospitalization in clinical practice. Palivizumab is a humanized murine monoclonal antibody that is approved by the US Food and Drug Administration (FDA) for the prevention of severe respiratory tract disease caused by RSV in children with BPD, infants with a history of premature birth (≤35 wGA), and children with hemodynamically significant CHD. Randomized controlled clinical trials of palivizumab versus placebo have shown a reduction in the incidence of hospitalization due to severe RSV disease by approximately 40%-80% in high-risk premature infants and certain children with CLD or CHD [7,10]. The key objective of this analysis was to examine the association between compliance with palivizumab and risk of RSV-related hospitalization among commercially insured infants

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