Outcomes of Palivizumab Prophylaxis for Respiratory Syncytial Virus Infection in Preterm Children with Bronchopulmonary Dysplasia at a Single Hospital in Korea from 2005 to 2009

Abstract

This study was performed to evaluate the utilization and outcomes of palivizumab in high risk children born prematurely with chronic lung disease (CLD). A retrospective review of 128 patients was conducted from September 2004 to March 2009 at the Ajou University Hospital. All patients were diagnosed with CLD, were born at ≤35 weeks of gestation, were <2 yr old at the onset of respiratory syncytial virus (RSV) season, and had received medical therapy within six months prior to the RSV season. Fifty-three patients did not receive palivizumab prophylaxis and 75 patients received at least one dose of palivizumab. There were no statistically significant differences between the patients with and without palivizumab prophylaxis with regard to demographic characteristics and risk factors for RSV infection. There were no systemic adverse responses. Compliance with the course of prophylaxis was 92.2%. Hospitalization associated with RSV occurred in 12 cases (22.6%) in the group without prophylaxis and in three cases (4.0%) with prophylaxis. Palivizumab prophylaxis significantly reduced the frequency of RSV-related hospitalization in preterm children with CLD. This is the first retrospective review of palivizumab prophylaxis in Korea. Palivizumab is effective and well tolerated in high risk prematurely born children.

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

“…In observational studies, the RSV‐related hospitalization rate range from 1.31% to 1.73% among children with BPD or CLD . An increased rate (2.70%) was also observed in children with upper airway anomalies and in preterm infants with BPD or CLD, not prophylaxed with palivizumab …”

“…Other observational studies had results with limited significance because of the poor number of enrolled CHD patients.…”

“…26,28,29 Lanari et al found a significant association with hospitalization for bronchiolitis with male sex, surfactants, siblings aged <10 years old, but it referred to bronchiolitis not necessary related to RSV. 28 Other observational studies [30][31][32][33][34][35][36][37][38][39][40][41][42][43] had results with limited significance because of selection bias, lack of control group, and poor number of enrolled patients.…”

“…23,44 An increased rate (2.70%) was also observed in children with upper airway anomalies 44 and in preterm infants with BPD or CLD, not prophylaxed with palivizumab. 30,37 Patients with BPD were considered in phase I/II RCTs that evaluated the safety and tolerance of palivizumab, 16,18 in phase III RCT that evaluated the efficacy of palivizumab prophylaxis versus placebo 2 and in phase IV study that compared the safety profile of two different formulation of palivizumab. 45 The IMpact study showed a reduction of 39% of the RSV hospitalization rate in BPD children (aged 24 months) prophylaxed with palivizumab compared to placebo recipients (7.9% vs. 12.8%).…”

“…49 Children with hemodynamically significant CHD were represented in two reviews, but no specific sub-group analyses were conducted. 11,12 Other observational studies 24,30,38,50,51 had results with limited significance because of the poor number of enrolled CHD patients.…”