Skip to main content
Top
Published in: European Journal of Clinical Microbiology & Infectious Diseases 7/2018

01-07-2018 | Original Article

Respiratory syncytial virus prophylaxis in cystic fibrosis: the Canadian registry of palivizumab data (2005–2016)

Authors: Ian Mitchell, S. K. Wong, B. Paes, M. Ruff, C. Bjornson, A. Li, K. L. Lanctôt, the CARESS investigators

Published in: European Journal of Clinical Microbiology & Infectious Diseases | Issue 7/2018

Login to get access

Abstract

Respiratory syncytial virus (RSV) may cause severe illness in cystic fibrosis (CF) children, but recommendations vary on prophylaxis. CARESS is a prospective registry of children who received palivizumab in 32 Canadian sites from 2005 to 2016. Demographic data were collected at enrollment and respiratory illness-related events recorded monthly. We reviewed respiratory illness hospitalization (RIH) and RSV hospitalization (RSVH) in CF children aged < 24 months versus those prophylaxed for standard indications (SI; prematurity, chronic lung disease [CLD] and congenital heart disease [CHD]), and complex medical disorders (CM). Of 23,228 children analyzed, 19,452 (83.8%) were SI, 3349 (14.4%) were CM, and 427 (1.8%) were CF. CF children were more likely to be Caucasian, heavier at birth and enrollment, and less likely to have a sibling or live in crowded conditions. CF children were similar to the other groups in daycare attendance, history of atopy, and exposure to smoking. RIH incidences were 4.3% (premature), 13.8% CLD, 11.5% CHD, 11.7% CM, and 6.8% CF. RSVH incidence in CF children was similar to that in the SI and CM groups: 1.1, 1.5, and 2.0% groups respectively. Cox regression analyses showed that compared to CF children, the HRs for RSVH in SI (HR 2.0 95% CI 0.5–8.3, p = 0.3) and CM (HR 2.4, 95% CI 0.6–9.8, p = 0.2) did not differ. CF children are equally at risk for RSVH relative to those prophylaxed for other indications. Pending robust evidence from prospective trials, palivizumab could perhaps be considered in the interim, for young CF patients born early during the RSV season with evidence of serious lung disease.
Literature
2.
go back to reference Therrell BL, Adams J (2007) Newborn screening in North America. J Inherit Metab Dis 30(4):447–465CrossRefPubMed Therrell BL, Adams J (2007) Newborn screening in North America. J Inherit Metab Dis 30(4):447–465CrossRefPubMed
3.
go back to reference Collins CL, Pollard AJ (2002) Respiratory syncytial virus infections in children and adults. J Inf Secur 45(1):10–17 Collins CL, Pollard AJ (2002) Respiratory syncytial virus infections in children and adults. J Inf Secur 45(1):10–17
4.
go back to reference Figueras-Aloy J, Manzoni P, Paes B, Simões EA, Bont L, Checchia PA, Fauroux B, Carbonell-Estrany X (2016) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among preterm infants without chronic lung disease or congenital heart disease. Infect Dis Ther 5(4):417–452CrossRefPubMedPubMedCentral Figueras-Aloy J, Manzoni P, Paes B, Simões EA, Bont L, Checchia PA, Fauroux B, Carbonell-Estrany X (2016) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among preterm infants without chronic lung disease or congenital heart disease. Infect Dis Ther 5(4):417–452CrossRefPubMedPubMedCentral
5.
go back to reference Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simões EA, Manzoni P, Carbonell-Estrany X (2016) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among infants with chronic lung disease. Infect Dis Ther 5(4):453–471CrossRefPubMedPubMedCentral Paes B, Fauroux B, Figueras-Aloy J, Bont L, Checchia PA, Simões EA, Manzoni P, Carbonell-Estrany X (2016) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among infants with chronic lung disease. Infect Dis Ther 5(4):453–471CrossRefPubMedPubMedCentral
6.
go back to reference Checchia PA, Paes B, Bont L, Manzoni P, Simões EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X (2017) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among infants with congenital heart disease. Infect Dis Ther 6(1):37–56CrossRefPubMedPubMedCentral Checchia PA, Paes B, Bont L, Manzoni P, Simões EA, Fauroux B, Figueras-Aloy J, Carbonell-Estrany X (2017) Defining the risk and associated morbidity and mortality of severe respiratory syncytial virus infection among infants with congenital heart disease. Infect Dis Ther 6(1):37–56CrossRefPubMedPubMedCentral
7.
go back to reference Manzoni P, Figueras-Aloy J, Simões EAF, Checchia PA, Fauroux B, Bont L, Paes B, Carbonell-Estrany X (2017) Defining the incidence and associated morbidity and mortality of severe respiratory syncytial virus infection among children with chronic diseases. Infect Dis Ther 6(3):383–411CrossRefPubMedPubMedCentral Manzoni P, Figueras-Aloy J, Simões EAF, Checchia PA, Fauroux B, Bont L, Paes B, Carbonell-Estrany X (2017) Defining the incidence and associated morbidity and mortality of severe respiratory syncytial virus infection among children with chronic diseases. Infect Dis Ther 6(3):383–411CrossRefPubMedPubMedCentral
8.
go back to reference Arnold SR, Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I (1999) Variable morbidity of respiratory syncytial virus infection in patients with underlying lung disease: a review of the PICNIC RSV database. Pediatric Investigators Collaborative Network on Infections in Canada. Pediatr Infect Dis J 18(10):866–869CrossRefPubMed Arnold SR, Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I (1999) Variable morbidity of respiratory syncytial virus infection in patients with underlying lung disease: a review of the PICNIC RSV database. Pediatric Investigators Collaborative Network on Infections in Canada. Pediatr Infect Dis J 18(10):866–869CrossRefPubMed
9.
go back to reference Abman SH, Ogle JW, Butler-Simon N, Rumack CM, Accurso FJ (1988) Role of respiratory syncytial virus in early hospitalizations for respiratory distress of young infants with cystic fibrosis. J Pediatr 113(5):826–830CrossRefPubMed Abman SH, Ogle JW, Butler-Simon N, Rumack CM, Accurso FJ (1988) Role of respiratory syncytial virus in early hospitalizations for respiratory distress of young infants with cystic fibrosis. J Pediatr 113(5):826–830CrossRefPubMed
10.
go back to reference Hiatt PW, Grace SC, Kozinetz CA, Raboudi SH, Treece DG, Taber LH, Piedra PA (1999) Effects of viral lower respiratory tract infection on lung function in infants with cystic fibrosis. Pediatrics 103(3):619–626CrossRefPubMed Hiatt PW, Grace SC, Kozinetz CA, Raboudi SH, Treece DG, Taber LH, Piedra PA (1999) Effects of viral lower respiratory tract infection on lung function in infants with cystic fibrosis. Pediatrics 103(3):619–626CrossRefPubMed
11.
go back to reference Murray J, Bottle A, Sharland M, Modi N, Aylin P, Majeed A, Saxena S, Medicines for Neonates Investigator Group (2014) Risk factors for hospital admission with RSV bronchiolitis in England: a population-based birth cohort study. PLoS One 9(2):e89186CrossRefPubMedPubMedCentral Murray J, Bottle A, Sharland M, Modi N, Aylin P, Majeed A, Saxena S, Medicines for Neonates Investigator Group (2014) Risk factors for hospital admission with RSV bronchiolitis in England: a population-based birth cohort study. PLoS One 9(2):e89186CrossRefPubMedPubMedCentral
12.
go back to reference Kristensen K, Hjuler T, Ravn H, Simões EA, Stensballe LG (2012) Chronic diseases, chromosomal abnormalities, and congenital malformations as risk factors for respiratory syncytial virus hospitalization: a population-based cohort study. Clin Infect Dis 54(6):810–817CrossRefPubMed Kristensen K, Hjuler T, Ravn H, Simões EA, Stensballe LG (2012) Chronic diseases, chromosomal abnormalities, and congenital malformations as risk factors for respiratory syncytial virus hospitalization: a population-based cohort study. Clin Infect Dis 54(6):810–817CrossRefPubMed
13.
go back to reference Borowitz D, Robinson KA, Rosenfeld M, Davis SD, Sabadosa KA, Spear SL, Michel SH, Parad RB, White TB, Farrell PM, Marshall BC, Accurso FJ (2009) Cystic Fibrosis Foundation evidence-based guidelines for management of infants with cystic fibrosis. J Pediatr 155(6 Suppl):S73–S93CrossRefPubMed Borowitz D, Robinson KA, Rosenfeld M, Davis SD, Sabadosa KA, Spear SL, Michel SH, Parad RB, White TB, Farrell PM, Marshall BC, Accurso FJ (2009) Cystic Fibrosis Foundation evidence-based guidelines for management of infants with cystic fibrosis. J Pediatr 155(6 Suppl):S73–S93CrossRefPubMed
14.
go back to reference Resch B (2017) Product review on the monoclonal antibody palivizumab for prevention of respiratory syncytial virus infection. Hum Vaccin Immunother 13(9):2138–2149CrossRefPubMedPubMedCentral Resch B (2017) Product review on the monoclonal antibody palivizumab for prevention of respiratory syncytial virus infection. Hum Vaccin Immunother 13(9):2138–2149CrossRefPubMedPubMedCentral
15.
go back to reference The IMpact-RSV Study Group (1998) Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high risk infants. Pediatrics 102(3 Pt 1):531–537 The IMpact-RSV Study Group (1998) Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high risk infants. Pediatrics 102(3 Pt 1):531–537
16.
go back to reference Feltes TF, Cabalka AK, Meissner HC, Piazza FM, Carlin DA, Top FH, Connor EM, Sondheimer HM, Cardiac Synagis Study Group (2003) Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 143(4):532–540CrossRefPubMed Feltes TF, Cabalka AK, Meissner HC, Piazza FM, Carlin DA, Top FH, Connor EM, Sondheimer HM, Cardiac Synagis Study Group (2003) Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 143(4):532–540CrossRefPubMed
17.
go back to reference Feltes TF, Sondheimer HM, Tulloh RM, Harris BS, Jensen KM, Losonsky GA, Griffin MP, Motavizumab Cardiac Study Group (2011) A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease. Pediatr Res 70(2):186–191CrossRefPubMed Feltes TF, Sondheimer HM, Tulloh RM, Harris BS, Jensen KM, Losonsky GA, Griffin MP, Motavizumab Cardiac Study Group (2011) A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease. Pediatr Res 70(2):186–191CrossRefPubMed
18.
go back to reference Gaboli M, de la Cruz Ò, de Agüero MI, Moreno-Galdó A, Pérez GP, de Querol MS (2014) Use of palivizumab in infants and young children with severe respiratory disease: a Delphi study. Pediatr Pulmonol 49(5):490–502CrossRefPubMed Gaboli M, de la Cruz Ò, de Agüero MI, Moreno-Galdó A, Pérez GP, de Querol MS (2014) Use of palivizumab in infants and young children with severe respiratory disease: a Delphi study. Pediatr Pulmonol 49(5):490–502CrossRefPubMed
19.
go back to reference Sánchez-Solis M, Gartner S, Bosch-Gimenez V, Garcia-Marcos L (2015) Is palivizumab effective as a prophylaxis of respiratory syncytial virus infections in cystic fibrosis patients? A meta-analysis. Allergol Immunopathol (Madr) 43(3):298–303CrossRef Sánchez-Solis M, Gartner S, Bosch-Gimenez V, Garcia-Marcos L (2015) Is palivizumab effective as a prophylaxis of respiratory syncytial virus infections in cystic fibrosis patients? A meta-analysis. Allergol Immunopathol (Madr) 43(3):298–303CrossRef
20.
go back to reference Paes B, Mitchell I, Li A, Harimoto T, Lanctôt KL (2013) Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries. Clin Dev Immunol 2013:917068CrossRefPubMedPubMedCentral Paes B, Mitchell I, Li A, Harimoto T, Lanctôt KL (2013) Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries. Clin Dev Immunol 2013:917068CrossRefPubMedPubMedCentral
21.
go back to reference Manzoni P, Paes B, Lanctôt KL, Dall'Agnola A, Mitchell I, Calabrese S, Maule M, Girardi E, Harimoto T, Li A (2017) Outcomes of infants receiving palivizumab prophylaxis for respiratory syncytial virus in Canada and Italy: an international, prospective cohort study. Pediatr Infect Dis J 36(1):2–8CrossRefPubMed Manzoni P, Paes B, Lanctôt KL, Dall'Agnola A, Mitchell I, Calabrese S, Maule M, Girardi E, Harimoto T, Li A (2017) Outcomes of infants receiving palivizumab prophylaxis for respiratory syncytial virus in Canada and Italy: an international, prospective cohort study. Pediatr Infect Dis J 36(1):2–8CrossRefPubMed
22.
go back to reference Groves HE, Jenkins L, Macfarlane M, Reid A, Lynn F, Shields MD (2016) Efficacy and long-term outcomes of palivizumab prophylaxis to prevent respiratory syncytial virus infection in infants with cystic fibrosis in Northern Ireland. Pediatr Pulmonol 51(4):379–385CrossRefPubMed Groves HE, Jenkins L, Macfarlane M, Reid A, Lynn F, Shields MD (2016) Efficacy and long-term outcomes of palivizumab prophylaxis to prevent respiratory syncytial virus infection in infants with cystic fibrosis in Northern Ireland. Pediatr Pulmonol 51(4):379–385CrossRefPubMed
23.
go back to reference Mitchell I, Paes BA, Li A, Lanctôt KL, CARESS investigators (2011) The Canadian registry of palivizumab. Pediatr Infect Dis J 30(8):651–655CrossRefPubMed Mitchell I, Paes BA, Li A, Lanctôt KL, CARESS investigators (2011) The Canadian registry of palivizumab. Pediatr Infect Dis J 30(8):651–655CrossRefPubMed
24.
go back to reference Kua KP, Lee SWH (2017) Systematic review of the safety and efficacy of palivizumab among infants and young children with cystic fibrosis. Pharmacotherapy 37(6):755–769CrossRefPubMed Kua KP, Lee SWH (2017) Systematic review of the safety and efficacy of palivizumab among infants and young children with cystic fibrosis. Pharmacotherapy 37(6):755–769CrossRefPubMed
25.
go back to reference Robinson JL, Le Saux N, Canadian Paediatric Society, Infectious Diseases and Immunization Committee (2015) Preventing hospitalizations for respiratory syncytial virus infection. Paediatr Child Health 20(6):321–333CrossRefPubMedPubMedCentral Robinson JL, Le Saux N, Canadian Paediatric Society, Infectious Diseases and Immunization Committee (2015) Preventing hospitalizations for respiratory syncytial virus infection. Paediatr Child Health 20(6):321–333CrossRefPubMedPubMedCentral
26.
go back to reference American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee (2014) Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 134(2):e620–e638CrossRef American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee (2014) Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 134(2):e620–e638CrossRef
27.
go back to reference Robinson KA, Odelola OA, Saldanha IJ (2016) Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev 7:CD007743PubMed Robinson KA, Odelola OA, Saldanha IJ (2016) Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev 7:CD007743PubMed
28.
go back to reference Cohen AH, Boron ML, Gaithersburg DC (2005) A phase IV study of the safety of Synagis (palivizumab) for the prophylaxis of respiratory disease in children with cystic fibrosis [Abstract]. International Meeting, SanDiego, California Cohen AH, Boron ML, Gaithersburg DC (2005) A phase IV study of the safety of Synagis (palivizumab) for the prophylaxis of respiratory disease in children with cystic fibrosis [Abstract]. International Meeting, SanDiego, California
Metadata
Title
Respiratory syncytial virus prophylaxis in cystic fibrosis: the Canadian registry of palivizumab data (2005–2016)
Authors
Ian Mitchell
S. K. Wong
B. Paes
M. Ruff
C. Bjornson
A. Li
K. L. Lanctôt
the CARESS investigators
Publication date
01-07-2018
Publisher
Springer Berlin Heidelberg
Published in
European Journal of Clinical Microbiology & Infectious Diseases / Issue 7/2018
Print ISSN: 0934-9723
Electronic ISSN: 1435-4373
DOI
https://doi.org/10.1007/s10096-018-3256-0

Other articles of this Issue 7/2018

European Journal of Clinical Microbiology & Infectious Diseases 7/2018 Go to the issue