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Palivizumab prophylaxis for respiratory syncytial virus in Canada: utilization and outcomes
Paul I Oh1, Krista L Lanctôt, Alice Yoon
1HOPE Research Centre, Sunnybrook, and Women's College Health Sciences Centre, University of Toronto, Ontario, Canada. paul.oh@swchsc.on.ca
Insights
Palivizumab prophylaxis significantly reduced hospitalizations for respiratory syncytial virus (RSV) lower respiratory tract infections in high-risk infants. This RSV prevention method demonstrated good tolerability and high compliance among participants.
Area of Science:
- Pediatrics
- Infectious Diseases
- Immunology
Background:
- Respiratory Syncytial Virus (RSV) poses a significant threat to high-risk infants, including premature infants and those with bronchopulmonary dysplasia.
- Palivizumab is a monoclonal antibody used for RSV prophylaxis in these vulnerable populations.
Purpose of the Study:
- To evaluate the real-world use and effectiveness of palivizumab prophylaxis in Canadian infants at high risk for serious RSV infection.
- To assess the incidence and severity of RSV-related lower respiratory tract infections (LRTIs) and hospitalizations.
Main Methods:
- An observational, prospective, longitudinal, multicenter study conducted across 18 Canadian hospitals and clinics.
- Enrolled 444 high-risk infants (primarily premature or with bronchopulmonary dysplasia) in the palivizumab Special Access Programme during the 1999-2000 RSV season.
- Collected neonatal, demographic, palivizumab utilization, compliance, and respiratory infection data through monthly caregiver contact.
Main Results:
- 444 infants received 1702 doses of palivizumab, with high compliance and discontinuation in only 2% of cases.
- An overall incidence of 2.4% for RSV-positive lower respiratory tract infection (LRTI) hospitalizations was observed.
- Infants with bronchopulmonary dysplasia had a higher hospitalization rate (6.0%) compared to those with prematurity only (1.6%).
Conclusions:
- Palivizumab prophylaxis was associated with a low rate of hospitalization for RSV-positive LRTIs in high-risk infants.
- The study confirmed the safety and effectiveness of palivizumab, demonstrating good tolerability and high compliance.
- Findings support the use of palivizumab for RSV prevention in eligible pediatric populations.
Objective:
To provide information on the use and outcomes of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus (RSV) infection.
Design:
Observational, prospective, longitudinal, multicenter study.
Setting:
Eighteen hospitals and pediatric clinics located in six provinces across Canada.
Patients:
Infants enrolled in the palivizumab Special Access Programme of Canada's Therapeutic Products Programme throughout the 1999 to 2000 RSV season. Most were premature infants born at < or = 32 weeks of gestation and/or had bronchopulmonary dysplasia.
Methods And Main Outcome Measures:
Neonatal and demographic data were recorded for each subject. The parent/caregiver was contacted on a monthly basis until the end of the RSV season to obtain information on palivizumab utilization and compliance as well as incidence and severity of respiratory infections.
Results:
There were 444 evaluable subjects who each received 1 to 7 injections of palivizumab for a total of 1702 doses from September 1999 to April 2000. Most subjects received 5 injections with high compliance. Prophylaxis was discontinued in 2% of children. There were 116 clinical events or hospitalizations involving respiratory tract infections reported in 91 children. Eighty-six of these were managed in an outpatient setting, and 30 required hospitalization. The estimated incidence of hospitalization for RSV-positive lower respiratory tract infections (LRTIs) was 2.4%. Hospitalization for RSV LRTI occurred more often in children with bronchopulmonary dysplasia (6.0%) than in those with prematurity only (1.6%).
Conclusions:
This study demonstrates that prophylaxis with palivizumab during the RSV season was associated with a low rate of hospitalization for RSV-positive LRTIs. Palivizumab was well-tolerated, and compliance was high. The findings confirm the results of the major randomized clinical trial of palivizumab and demonstrate the safety and effectiveness of RSV prophylaxis.