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Observational Study
. 2022 Nov;39(15):1668-1677.
doi: 10.1055/s-0041-1725146. Epub 2021 Mar 3.

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada

Ian Mitchell  1 , Abby Li  2 , Candice L Bjornson  1 , Krista L Lanctot  2 , Bosco A Paes  3 ; CARESS investigators
Affiliations
Observational Study

Respiratory Syncytial Virus Immunoprophylaxis with Palivizumab: 12-Year Observational Study of Usage and Outcomes in Canada

Ian Mitchell et al. Am J Perinatol. 2022 Nov.

Abstract

Objective: This study aimed to evaluate palivizumab (PVZ) use, trends in indications, and outcomes of respiratory illness hospitalizations (RIH) and respiratory syncytial virus hospitalizations (RSVH).

Study design: It involves a large, Canadian prospective (2005-2017) observational multicenter study of children at high risk for RSV infection.

Results: A total of 25,003 infants (56.3% male) were enrolled at 32 sites; 109,579 PVZ injections were administered. Indications included: prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%). The "miscellaneous" group increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017) and included: trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group. Adherence measured by expected versus actual doses plus correct interdose interval was 64.7%. A total of 2,054 RIH occurred (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH 1.6%). Risk factors for RSVH included having siblings, attending daycare, family history of atopy, smoking exposure, and crowded household. Infants with 5 risk factors were 9.0 times (95% CI or confidence interval 4.4-18.2; p < 0.0005) more likely to have RSVH than infants without risk factors. Three adverse events occurred; none were fatal.

Conclusion: Results are relevant to both clinicians and decision-makers. We confirmed the safety of PVZ. Use of PVZ increased steadily for children with miscellaneous conditions and medical complexity. Medical and social factors pose a risk for severe RIH and RSVH with accompanying burden of illness. A vaccine that protects against RSV is urgently required.

Key points: · Main indications were prematurity (63.3%); "miscellaneous" (17.8%); hemodynamically significant congenital heart disease (10.5%); bronchopulmonary dysplasia/chronic lung disease (8.4%).. · The proportion of children in the "miscellaneous" group, comprised of those with trisomy 21, airway anomalies, pulmonary disorders, cystic fibrosis, neurological impairments, immunocompromised, cardiac aged >2 years, multiple conditions, and a residual "unclassified" group, increased over time (4.4% in 2005-2006 to 22.5% in 2016-2017).. · Respiratory illness-related hospitalization occurred in 2,054 children (6.9%); 198 (9.6%) required intubation. Three hundred thirty-seven hospitalized children were RSV-positive (overall RSVH: 1.6%)..

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Conflict of interest statement

B.A.P., I.M., K.L.L., and C.L.B. have received investigator-initiated research funding or received compensation as advisors or lecturers from AbbVie Corporation, Merck and MedImmune. A.L. has no conflicts of interest to disclose. I.M. reports grant from AbbVie CANADA, other from AbbVie Canada, during the conduct of the study; grants from Regeneron, grants from Medimmune, outside the submitted work. C.L.B. reports grant from Abbvie, during the conduct of the study; other from Regeneron, outside the submitted work. B.A.P. reports grants and personal fees from AbbVie Incorporated, personal fees from Merck, during the conduct of the study. K.L.L. reports grants and personal fees from AbbVie, outside the submitted work. A.L. reports grant from AbbVie Canada, during the conduct of the study.

Figures

Fig. 1
Fig. 1
Comparison of the geographical distribution among the CARESS and Canadian populations. CARESS, Canadian Respiratory Syncytial Virus Evaluation Study of Palivizumab.
Fig. 2
Fig. 2
Changing proportions of indications for palivizumab by RSV season. BPD, bronchopulmonary dysplasia; CLD, chronic lung disease; HSCHD, hemodynamically significant congenital heart disease; RSV, respiratory syncytial virus.
Fig. 3
Fig. 3
Hazard curve for Cox's proportional analysis based on the number of risk factors. Risk factors included: attending daycare, siblings, siblings in daycare, smoking exposure, family history of atopy, and household crowding (≥5 individuals in the household). RSV, respiratory syncytial virus.
Fig. 4
Fig. 4
Hazard curve for Cox's proportional analysis for respiratory syncytial virus hospitalization based on indication. BPD, bronchopulmonary dysplasia; CHD, congenital heart disease; RSV, respiratory syncytial virus.
See this image and copyright information in PMC

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