CARESS: the Canadian registry of palivizumab
Ian Mitchell1, Bosco A Paes, Abby Li
1Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, AB, Canada.
Insights
This study tracked high-risk infants receiving palivizumab (RSV prophylaxis) and found an RSV hospitalization rate of 1.38%. Compliance with dosing was generally good, though having siblings increased hospitalization risk.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Palivizumab is used for respiratory syncytial virus (RSV) prophylaxis in high-risk infants.
- Limited data exist on its current usage, adherence, and patient outcomes.
Purpose of the Study:
- To evaluate the real-world use, compliance, and outcomes of palivizumab for RSV prophylaxis in high-risk children.
- To assess RSV-related hospitalization rates in this cohort.
Main Methods:
- A prospective, observational registry study conducted across 27 sites.
- Monthly follow-up of infants at high risk for RSV who received palivizumab between 2005-2009.
- Data collected on demographics, reasons for prophylaxis, doses administered, and hospitalizations.
Main Results:
- 5286 high-risk infants were enrolled, with the majority receiving prophylaxis for prematurity.
- Infants received 86% of expected doses, with 71.2% administered within recommended timeframes.
- The overall hospitalization rate for respiratory tract illness was 5.8%, with an RSV-specific hospitalization rate of 1.38%.
Conclusions:
- The RSV hospitalization rate aligns with previous findings but did not show declining trends observed elsewhere.
- Factors like increased RSV testing and prophylaxis for underlying conditions may influence observed rates.
- Having siblings was associated with an increased likelihood and earlier time to hospitalization.
Background:
Palivizumab is indicated for respiratory syncytial virus (RSV) prophylaxis in high-risk children. However, relatively little is known about the current use, compliance, and outcomes associated with this medication.
Methods:
A prospective, observational, registry based on 27 sites, with monthly follow-up of infants at high risk for RSV who received at least 1 dose of palivizumab during the 2005-2009 RSV seasons.
Results:
A total of 5286 children were enrolled (56.6% male; 71.7% white; average gestational age, 32.1 ± 5.5 weeks). Of them, 3741 patients (70.8%) were prophylaxed for prematurity only, 449 (8.5%) for bronchopulmonary dysplasia/chronic lung disease, 508 (9.6%) for congenital heart disease, and 588 (11.1%) for other reasons. Overall, 19,485 doses were given. On average, infants received 86.0% ± 28.4% of their expected number of injections; 71.2% of infants received their injections in the recommended time periods. Of the 5286 participants enrolled, 308 patients were hospitalized for respiratory tract illness (hospitalization rate, 5.8%). The RSV-hospitalization rate was calculated as 1.38%. Having siblings increased likelihood of hospitalization (66.9% vs. 55.7%, P < 0.005), and was significantly correlated with time to hospitalization in this cohort (P = 0.050).
Conclusions:
The overall RSV-hospitalization rate in our study was within the range found in previous reports (1.3%-5.3%), although it did not mimic the declining rates of the US Palivizumab Outcomes Registry. This could be due to increased testing for RSV when hospitalized and increasing rates of prophylaxis of infants with underlying medical disorders.
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