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Comparing First- and Second-year Palivizumab Prophylaxis in Patients With Hemodynamically Significant Congenital
Abby Li1, Daniel Y Wang, Krista L Lanctôt
1From the *Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; †Division of Respirology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; and ‡Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Insights
Infants with hemodynamically significant congenital heart disease (HSCHD) face similar risks of respiratory syncytial virus hospitalization (RSVH) in their second year of life, suggesting continued palivizumab prophylaxis is warranted for unstable infants.
Area of Science:
- Pediatric Cardiology
- Infectious Diseases
- Neonatology
Background:
- Infants with hemodynamically significant congenital heart disease (HSCHD) have a 2- to 4-fold higher risk of respiratory syncytial virus hospitalization (RSVH) compared to healthy infants.
- Current pediatric guidelines present differing recommendations regarding the benefit of palivizumab prophylaxis beyond the first year of life for these vulnerable infants.
Purpose of the Study:
- To investigate the incidence of respiratory-related illness hospitalization (RIH) and RSVH in infants with HSCHD receiving palivizumab during their first versus second year of life.
- To evaluate the comparative risk of RSVH and other respiratory illnesses in HSCHD infants during these two distinct age periods.
Main Methods:
- Utilized data from the Canadian Registry of Palivizumab, a prospective database of infants receiving palivizumab from 2005 to 2015.
- Included infants under 24 months of age with HSCHD, collecting demographic data and monthly RIH event records.
- Employed Cox regression analysis to compare the hazard of RIH and RSVH between infants receiving prophylaxis in their first versus second year of life.
Main Results:
- Of 1909 HSCHD infants, 1380 received prophylaxis in the first year and 529 in the second year.
- Second-year infants had a more complicated neonatal course, longer hospital stays, and differing baseline demographics compared to first-year infants.
- The rates of RIH (11.2% vs. 10.6%) and RSVH (2.3% vs. 1.7%) were similar between the first and second year of life, with no significant difference in hazard ratios for either outcome.
Conclusions:
- Infants with HSCHD demonstrated similar risks for RSVH in both their first and second year of life.
- These findings support the continued use of palivizumab prophylaxis for unstable infants with HSCHD in their second year of life, as they remain at significant risk.
Background:
Respiratory syncytial virus hospitalization (RSVH) rates in children <2 years of age with hemodynamically significant congenital heart disease (HSCHD) are 2- to 4-fold higher compared with healthy term infants. Pediatric recommendations differ as to whether palivizumab is beneficial beyond 1 year of age. The objective of this study was to determine whether differences exist in respiratory-related illness hospitalization (RIH) and RSVH in HSCHD infants receiving palivizumab during the first year versus second year of life in the Canadian Registry of Palivizumab.
Methods:
The Canadian Registry of Palivizumab is a prospective database of infants who received ≥1 dose of palivizumab in 32 hospitals from 2005 to 2015. Demographic data were collected at enrollment and RIH events recorded monthly. Infants <24 months of age with HSCHD were recruited.
Results:
Of 1909 HSCHD infants, 1380 (72.3%) in the first year (mean age, 4.2 months) and 529 (27.7%) in the second year of life (mean age, 17.8 months) received prophylaxis. Baseline demographics for day-care attendance, multiple births, enrollment age and weight differed between the groups (all P < 0.05). Additionally, second year infants had a more complicated neonatal course, with significantly longer length of stay (51.2 vs. 24.9 days) compared with those in the first year. The RIH and RSVH rates in the first year were 11.2% and 2.3% and in the second year were 10.6% and 1.7%. Cox regression analysis showed similar hazard for RIH [hazard ratio, 1.9; 95% confidence interval: 0.7-4.6; P = 0.18] and RSVH [hazard ratio, 2.0; 95% confidence interval: 0.2-16.5; P = 0.52].
Conclusions:
Infants in the first and second year of life had a similar RSVH hazard. These findings suggest that infants in the second year with HSCHD, who remain unstable, are equally at risk for RSVH and merit prophylaxis.