Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries.

Bosco Paes,Tetsuhiro Harimoto,Ian Mitchell,Krista L Lanctôt,Abby Li

doi:10.1155/2013/917068

Abstract

Respiratory syncytial virus (RSV) infection occurs commonly in infants aged ≤2 years, and severe infection results in hospitalization with accompanying morbidity and mortality. Palivizumab has been available for prophylaxis for the past 15 years. Prospective data on patients who received palivizumab from 2005 to 2012 has been assembled in the Canadian registry (CARESS) to document utilization, compliance, and health outcomes in both hospital and community settings. Long-term data is necessary to evaluate the impact of palivizumab on the incidence of RSV infections, minimize healthcare resources, and identify which infant subpopulations are receiving prophylaxis. A database search was also conducted for similar information from published registries, and hospitalization rates were compared to results from randomized clinical trials (RCTs).Overall hospitalization rates (percent; range) for respiratory-related illnesses and RSV-specific infection in infants who meet standard indications for prophylaxis were 6.6 (3.3–7.7) and 1.55 (0.3–2.06), respectively, in CARESS, which closely aligns with registry data from 4 other countries, despite the former comprising the largest cohort of complex patients internationally. Overall RSV-related hospitalization rates were lower across registries compared to equivalent patients in RCTs. Registry data provides valuable information regarding real-world experience with palivizumab, while facilitating the genesis of new research themes.

Highlights

Respiratory syncytial virus (RSV) continues to play a dominant role among the spectrum of viruses causing acute lower respiratory infection and subsequent hospitalization in infants and young children [1,2,3,4,5,6]
Over the 7 years, 65.7% of patients prophylaxed with palivizumab were premature, 7.9% had chronic lung disease (CLD) only and were not classified in any other category, 10.6% had Hemodynamically significant congenital heart disease (HSCHD), and 15.8% had “other” serious medical disorders
Over the seven RSV seasons encompassed by CARESS, there has been a 4.3-fold increase in the percentage of patients recruited that have been prophylaxed for serious underlying medical disorders, from 4.4% in the 2005-2006 RSV season to 18.8% in the 2011-2012 RSV season

Summary

Introduction

Respiratory syncytial virus (RSV) continues to play a dominant role among the spectrum of viruses causing acute lower respiratory infection and subsequent hospitalization in infants and young children [1,2,3,4,5,6]. Palivizumab, a humanized monoclonal antibody that targets the A antigenic site of the F-protein of RSV for the prevention of disease in high-risk children, demonstrates both neutralizing and fusion-inhibitory activity [14]. It was licensed in the USA by the Food and Drug Administration (FDA) in 1998 and subsequently by the European Medicines Evaluation Agency (EMEA) in 1999. Two major randomized, double-blind, placebo controlled trials [15, 16] and several follow-up studies [17, 18] have established the safety and efficacy of palivizumab in premature infants aged < 6 months who are ≤35 weeks gestational age and in children

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