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Effectiveness of palivizumab prophylaxis in infants and children in Florida

Authors

  • Almut G. Winterstein,

    Corresponding author
    1. Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA
    • Department of Epidemiology, Colleges of Medicine and Public Health & Health Professions, University of Florida, Gainesville, FL, USA
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  • Christian Hampp,

    1. Division of Epidemiology I, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
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  • Arwa Saidi

    1. Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA
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A. G. Winterstein, Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, PO Box 100496, Gainesville, FL 32610, USA.

E-mail: Almut@cop.ufl.edu

ABSTRACT

Purpose

Palivizumab effectiveness data on respiratory syncytial virus (RSV) infections are limited to trial settings and vary considerably between selected high-risk populations. This study aimed to evaluate effectiveness in a community-based sample.

Methods

We conducted a cohort study of children with ≥3 months Florida Medicaid fee-for-service eligibility between 1998 and 2004 who also had matching birth certificates. Children entered the cohort at the beginning of the RSV season, after a minimum of 60 days in ambulatory care, and were followed until the earliest of the following: season end, second birthday, loss of eligibility, hospitalization, or death. Study endpoint was the first RSV-related hospitalization. To evaluate the presence of confounding, a second endpoint, hospitalizations for pneumonia or bronchiolitis secondary to specified bacterial or viral pathogens other than RSV, was used. Palivizumab exposure defined as first use (day 1–30 of first dose), subsequent use (days 1–30 of each subsequent dose), and former use (days 31–60 after any dose if delays or no readministration occurred) was compared with non-use with a Cox regression model, adjusting for confounders.

Results

Hazard ratios (HRs) for RSV hospitalizations were 0.89 (95%CI, 0.71–1.12), 0.56 (95%CI, 0.46–0.69), and 0.71 (95%CI, 0.51–0.97) for first, subsequent, and former use, respectively. HRs for hospitalization because of non-RSV infections were 1.31 (95%CI, 1.04–1.65), 1.03 (95%CI, 0.86–1.23), and 1.05 (95%CI, 0.78–1.41), indicating residual confounding for first but not for subsequent and former use.

Conclusion

In this community-based study, palivizumab was associated with a reduction in severe RSV infections of a magnitude comparable to the lower clinical trial efficacy estimates. Protection appears to extend beyond the currently recommended monthly dosing schedule. Copyright © 2011 John Wiley & Sons, Ltd.

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