Abstract
Objective: To compare palivizumab utilization and compliance, and respiratory infection (RI) outcomes in subgroups of infants at high risk for RSV within the Canadian Registry Database.
Methods: A prospective, observational, registry of infants at 29 sites who received ≥1 dose of palivizumab during the 2006-2010 RSV seasons. Utilization and RI outcomes were collected monthly over the full course of palivizumab. Infants ≤35 completed weeks gestational age without medical conditions who met standard approval criteria (Group 1) were compared to those at high risk of RI due to underlying medical illnesses (Group 2).
Results: There were more infants in Group 1 (n=4880, 84%) than Group 2 (n=952, 16%). Group 2 included Down syndrome (20.2%), upper airway anomalies (18.5%), pulmonary disorders (13.3%), cystic fibrosis (12.3%), neuromuscular impairment (8.2%), multiple system disorders (6.1%), cardiac disorders (2.7%), immunocompromise (1.8%), and miscellaneous disorders (16.9%). From 2006-2010, the proportion of Group 2 infants increased 4-fold from 5.6% (69/1224) to 19.1% (462/2413). Group 2 was older at enrollment (10.2±9.2 vs 3.5±3.1 months, p<0.005), had more advanced gestational age (35.9±6.0 vs. 30.9±5.4 weeks, p<0.005) and had higher RI (9.0% vs. 4.2%, p<0.0005) and RSV hospitalization (2.35% vs 1.32%, p=0.003) rates. Group 2 infants tended to be less compliant with treatment (69.4% vs. 72.8%, p=0.048). Group (p=0.015) was an independent predictor of RSV hospitalization over compliance (p=0.951; model: χ2=5.273, df=1, p=0.022).
Conclusion: Results imply that infants with underlying medical disorders, though not currently approved for prophylaxis, are at an elevated risk for both RI and RSV hospitalization.
- © 2011 ERS