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Effectiveness of palivizumab prophylaxis in infants and children in Florida.
MedLine Citation:
PMID:  21919115     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Almut G Winterstein; Christian Hampp; Arwa Saidi
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-9-15
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  -     ISSN:  1099-1557     ISO Abbreviation:  -     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-9-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 John Wiley & Sons, Ltd.
Affiliation:
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. Almut@cop.ufl.edu.
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