Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

Pediatric Pulmonology

Volumn 51, Issue 10, 2016, Pages 1088-1096

  Pignotti, Maria Serenella ^a   Carmela Leo, Maria ^a   Pugi, Alessandra ^a   De Masi, Salvatore ^a   Biermann, Klaus Peter ^a   Galli, Luisa ^a   Vitali Rosati, Giovanni ^b   Buonocore, Giuseppe ^c   Mugelli, Alessandro ^d   Dani, Carlo ^d   Lucenteforte, Ersilia ^d   Bellini, Francesca ^a   Donzelli, Giampaolo ^a  

^a UNIVERSITY OF FLORENCE   (Italy)

^b Italian Society of Pediatrics Tuscany Section   (Italy)

^c UNIVERSITY OF SIENA   (Italy)

^d UNIVERSITY OF FLORENCE   (Italy)

Author keywords

bronchopulmonary dysplasia; consensus conference; neonatal pulmonary medicine; palivizumab; preterms

Indexed keywords

PALIVIZUMAB; ANTIVIRUS AGENT;

BRONCHIOLITIS; CHILD HEALTH CARE; CLINICAL PRACTICE; COMORBIDITY; CONSENSUS DEVELOPMENT; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; EPIDEMIC; EVIDENCE BASED MEDICINE; GESTATIONAL AGE; HUMAN; INFECTION PREVENTION; PREMATURITY; PRIORITY JOURNAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; REVIEW; SYSTEMATIC REVIEW; CHILD; HOSPITALIZATION; INFANT; ITALY; NEWBORN; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS;

ANTIVIRAL AGENTS; CHILD; GESTATIONAL AGE; HOSPITALIZATION; HUMANS; INFANT; INFANT, NEWBORN; ITALY; PALIVIZUMAB; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS;

EID: 84988380574     PISSN: 87556863     EISSN: 10990496     Source Type: Journal    
DOI: 10.1002/ppul.23561     Document Type: Review

References (63)

1. Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 2010; 375:1545–1555.
2. Suresh G. IMpact-RSV study group report. Pediatrics 1999; 104:993; author reply 995.
3. American Academy of Pediatrics Committee on infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134:e620–e638.
4. Caldwell NA, Townsend C. Where are we with RSV prophylaxis? Arch Dis Child Educ Pract Ed 2016; 101:38–42.
5. Società Italiana di Cardiologia Pediatrica. Linee guida della Società Italiana di Cardiologia Pediatrica sull'immunoprofilassi passiva con palivizumab dell'infezione da virus respiratorio nei bambini con cardiopatia congenita o acquisita nell'infanzia. Bollettino SICP 2006;13f:2–4.
6. Baraldi E, Lanari M, Manzoni P, Rossi GA, Vandini S, Rimini A, Romagnoli C, Colonna P, Biondi A, Biban P, et al. Inter-society consensus document on treatment and prevention of bronchiolitis in newborns and infants. Ital J Pediatr 2014; 40:65.
7. Bollani L BE, Chirico G, Dotta A, Lanari M, Del Vecchio A, Manzoni P, Boldrini A, Paolillo P, Di Fabio S, Orfeo L, et al. Raccomandazioni sulla profilassi dell'infezione da virus respiratorio sinciziale (VRS) con il palivizumab. Milan: Biomedia srl; 2015.
8. Società Italiana di Neonatologia (Sezione Toscana). Raccomandazioni per la profilassi dell'infezione da virus respiratorio sinciziale con palivizumab. Paper presented at: Annual meeting of the Società Italiana di Neonatologia Sezione Toscana 2015, Siena (Italy).
9. Sistema Nazionale Linee Guida. Come organizzare una conferenza di consenso. Milano: Zadig, 2009.
10. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: characteristics and guidelines for use. Am J Public Health 1984; 74:979–983.
11. Andabaka T, Nickerson JW, Rojas-Reyes MX, Rueda JD, Bacic Vrca V, Barsic B. Monoclonal antibody for reducing the risk of respiratory syncytial virus infection in children. Cochrane Database Syst Rev 2013; 4:Cd006602.
12. Morris SK, Dzolganovski B, Beyene J, Sung L. A meta-analysis of the effect of antibody therapy for the prevention of severe respiratory syncytial virus infection. BMC Infect Dis 2009; 9:106.
13. Wegzyn C, Toh LK, Notario G, Biguenet S, Unnebrink K, Park C, Makari D, Norton M. Safety and effectiveness of palivizumab in children at high risk of serious disease due to respiratory syncytial virus infection: a systematic review. Infect Dis Ther 2014; 3:133–158.
14. Tavsu I, Gursoy T, Dirman S, Erbil N, Ovali F. Palivizumab prophylaxis: does it have any influence on the growth and development of the infants? Am J Perinatol 2014; 31:667–672.
15. Blanken MO, Rovers MM, Molenaar JM, Winkler-Seinstra PL, Meijer A, Kimpen JL, Bont L, Dutch RSVNN. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. N Engl J Med 2013; 368:1791–1799.
16. Subramanian KN, Weisman LE, Rhodes T, Ariagno R, Sánchez PJ, Steichen J, Givner LB, Jennings TL, Top FH, Carlin D, et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. MEDI-493 Study Group. Pediatr Infect Dis J 1998; 17:110–115.
17. Robbie GJ, Makari D, Harris B, Losonsky GA, Jafri HS. Randomized, double-blind study of the pharmacokinetics and safety of palivizumab liquid formulation compared with lyophilized formulation. Infect Dis Ther 2014; 3:203–214.
18. Fernandez P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr 2010; 10:38.
19. Carbonell-Estrany X, Simoes EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA. Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial. Pediatrics 2010; 125:e35–e51.
20. Romero JR. Palivizumab prophylaxis of respiratory syncytial virus disease from 1998 to 2002: results from four years of palivizumab usage. Pediatr Infect Dis J 2003; 22:S46–S54.
21. Naver L, Eriksson M, Ewald U, Linde A, Lindroth M, Schollin J. Appropriate prophylaxis with restrictive palivizumab regimen in preterm children in Sweden. Acta Paediatr 2004; 93:1470–1473.
22. Lacaze-Masmonteil T, Truffert P, Pinquier D, Daoud P, Goldfarb G, Vicaut E, Fauroux B. Lower respiratory tract illness and RSV prophylaxis in very premature infants. Arch Dis Child 2004; 89:562–567.
23. Mitchell I, Paes BA, Li A, Lanctot KL. CARESS: the Canadian registry of palivizumab. Pediatr Infect Dis J 2011; 30:651–655.
24. Paes B, Mitchell I, Li A, Lanctot KL. A comparative study of respiratory syncytial virus (RSV) prophylaxis in premature infants within the Canadian Registry of Palivizumab (CARESS). Eur J Clin Microbiol Infect Dis 2012; 31:2703–2711.
25. Parnes C, Guillermin J, Habersang R, Nicholes P, Chawla V, Kelly T, Fishbein J, McRae P, Goessler M, Gatti A, et al. Palivizumab prophylaxis of respiratory syncytial virus disease in 2000–2001: results from The Palivizumab Outcomes Registry. Pediatr Pulmonol 2003; 35:484–489.
26. Hall CB, Weinberg GA, Blumkin AK, Edwards KM, Staat MA, Schultz AF, Poehling KA, Szilagyi PG, Griffin MR, Williams JV, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics 2013; 132:e341–e348.
27. Robinson JL, Le Saux N. Canadian paediatric society ID, Immunization C. Preventing hospitalizations for respiratory syncytial virus infection. Paediatr Child Health 2015; 20:321–333.
28. Lanari M, Prinelli F, Adorni F, Di Santo S, Vandini S, Silvestri M, Musicco M. Study Group of Italian Society of Neonatology on Risk Factors for RSVH. Risk factors for bronchiolitis hospitalization during the first year of life in a multicenter Italian birth cohort. Ital J Pediatr 2015; 41:40.
29. Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009; 360:588–598.
30. Chang SG, Park MS, Yu JE. Outcomes of palivizumab prophylaxis for respiratory syncytial virus infection in preterm children with bronchopulmonary dysplasia at a single hospital in Korea from 2005 to 2009. J Korean Med Sci 2010; 25:251–256.
31. DeVincenzo JP, Aitken J, Harrison L. Respiratory syncytial virus (RSV) loads in premature infants with and without prophylactic RSV fusion protein monoclonal antibody. J Pediatr 2003; 143:123–126.
32. Frogel M, Nerwen C, Cohen A, VanVeldhuisen P, Harrington M, Boron M. Prevention of hospitalization due to respiratory syncytial virus: results from the Palivizumab Outcomes Registry. J Perinatol 2008; 28:511–517.
33. Grimaldi M, Gouyon B, Sagot P, Quantin C, Huet F, Gouyon JB. Palivizumab efficacy in preterm infants with gestational age
34. Groothuis JR. Safety of palivizumab in preterm infants 29 to 32 weeks' gestational age without chronic lung disease to prevent serious respiratory syncytial virus infection. Eur J Clin Microbiol Infect Dis 2003; 22:414–417.
35. Mitchell I, Tough S, Gillis L, Majaesic C. Beyond randomized controlled trials: a “real life” experience of respiratory syncytial virus infection prevention in infancy with and without palivizumab. Pediatr Pulmonol 2006; 41:1167–1174.
36. Oncel MY, Mutlu B, Kavurt S, Bas AY, Demirel N, Akyol M, Erdeve O, Dilmen U. Respiratory syncytial virus prophylaxis in preterm infants: a cost-effectiveness study from Turkey. Turk J Pediatr 2012; 54:344–351.
37. Pedraz C, Carbonell-Estrany X, Figueras-Aloy J, Quero J. Effect of palivizumab prophylaxis in decreasing respiratory syncytial virus hospitalizations in premature infants. Pediatr Infect Dis J 2003; 22:823–827.
38. Resch B, Gusenleitner W, Muller WD, Haas J. Observational study of respiratory syncytial virus-associated hospitalizations and use of palivizumab in premature infants aged 29–32 weeks. Eur J Clin Microbiol Infect Dis 2006; 25:120–122.
39. Simoes EA, Groothuis JR, Carbonell-Estrany X, Rieger CH, Mitchell I, Fredrick LM, Kimpen JL. Palivizumab prophylaxis, respiratory syncytial virus, and subsequent recurrent wheezing. J Pediatr 2007; 151:34–42.
40. Sorrentino M, Powers T. Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group. Pediatr Infect Dis J 2000; 19:1068–1071.
41. Vogel AM, McKinlay MJ, Ashton T, Lennon DR, Harding JE, Pinnock R, Graham D, Grimwood K, Pattemore PK, Schousboe M. Cost-effectiveness of palivizumab in New Zealand. J Paediatr Child Health 2002; 38:352–357.
42. Yoshihara S, Kusuda S, Mochizuki H, Okada K, Nishima S, Simoes EA. Effect of palivizumab prophylaxis on subsequent recurrent wheezing in preterm infants. Pediatrics 2013; 132:811–818.
43. Elhassan NO, Sorbero ME, Hall CB, Stevens TP, Dick AW. Cost-effectiveness analysis of palivizumab in premature infants without chronic lung disease. Arch Pediatr Adolesc Med 2006; 160:1070–1076.
44. Paes B, Mitchell I, Li A, Lanctot KL. Respiratory hospitalizations and respiratory syncytial virus prophylaxis in special populations. Eur J Pediatr 2012; 171:833–841.
45. Makari D, Jensen KM, Harris B, Jafri HS. Randomized, double-blind study of the safety of the liquid versus lyophilized formulation of palivizumab in premature infants and children with chronic lung disease of prematurity. Infect Dis Ther 2014; 3:339–347.
46. Granbom E, Fernlund E, Sunnegardh J, Lundell B, Naumburg E. Evaluating national guidelines for the prophylactic treatment of respiratory syncytial virus in children with congenital heart disease. Acta Paediatr (Oslo, Norway: 1992) 2014; 103:840–845.
47. Cohen SA, Zanni R, Cohen A, Harrington M, VanVeldhuisen P, Boron ML. Palivizumab use in subjects with congenital heart disease: results from the 2000-2004 Palivizumab Outcomes Registry. Pediatr Cardiol 2008; 29:382–387.
48. Feltes TF, Cabalka AK, Meissner HC, Piazza FM, Carlin DA, Top FH, Connor EM, Sondheimer HM. Cardiac Synagis Study G. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr 2003; 143:532–540.
49. Feltes TF, Sondheimer HM, Tulloh RM, Harris BS, Jensen KM, Losonsky GA, Griffin MP. 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 2011; 70:186–191.
50. Alexander PM, Eastaugh L, Royle J, Daley AJ, Shekerdemian LS, Penny DJ. Respiratory syncytial virus immunoprophylaxis in high-risk infants with heart disease. J Paediatr Child Health 2012; 48:395–401.
51. Harris KC, Anis AH, Crosby MC, Cender LM, Potts JE, Human DG. Economic evaluation of palivizumab in children with congenital heart disease: a Canadian perspective. Can J Cardiol 2011; 27:523.e511–e525.
52. Paes B, Mitchell I, Yi H, Li A, Lanctot KL. Hospitalization for respiratory syncytial virus illness in Down syndrome following prophylaxis with palivizumab. Pediatr Infect Dis J 2014; 33:e29–e33.
53. Yi H, Lanctot KL, Bont L, Bloemers BL, Weijerman M, Broers C, Li A, Kiss A, Mitchell I, Paes B. Respiratory syncytial virus prophylaxis in Down syndrome: a prospective cohort study. Pediatrics 2014; 133:1031–1037.
54. de Fontbrune FS, Robin M, Porcher R, Scieux C, de Latour RP, Ferry C, Rocha V, Boudjedir K, Devergie A, Bergeron A, et al. Palivizumab treatment of respiratory syncytial virus infection after allogeneic hematopoietic stem cell transplantation. Clin Infect Dis 2007; 45:1019–1024.
55. Boeckh M, Berrey MM, Bowden RA, Crawford SW, Balsley J, Corey L. Phase 1 evaluation of the respiratory syncytial virus-specific monoclonal antibody palivizumab in recipients of hematopoietic stem cell transplants. J Infect Dis 2001; 184:350–354.
56. Robinson KA, Odelola OA, Saldanha IJ, McKoy NA. Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis. Cochrane Database Syst Rev 2013; 6:CD007743.
57. Elnazir B, Oni O, Hassan T, Greally P, Paes B. Does prophylaxis with palivizumab reduce hospitalisation rates for respiratory-syncytial-virus-related infection in cystic fibrosis children less than 2 years of age? J Paediatr Child Health 2012; 48:1033–1038.
58. Sanchez-Solis M, Gartner S, Bosch-Gimenez V, Garcia-Marcos L. Is palivizumab effective as a prophylaxis of respiratory syncytial virus infections in cystic fibrosis patients? A meta-analysis. Allergol Immunopathol (Madr) 2015; 43:298–303.
59. Speer ME, Fernandes CJ, Boron M, Groothuis JR. Use of Palivizumab for prevention of hospitalization as a result of respiratory syncytial virus in infants with cystic fibrosis. Pediatr Infect Dis J 2008; 27:559–561.
60. Giebels K, Marcotte JE, Podoba J, Rousseau C, Denis MH, Fauvel V, Laberge S. Prophylaxis against respiratory syncytial virus in young children with cystic fibrosis. Pediatr Pulmonol 2008; 43:169–174.
61. Winterstein AG, Eworuke E, Xu D, Schuler P. Palivizumab immunoprophylaxis effectiveness in children with cystic fibrosis. Pediatr Pulmonol 2013; 48:874–884.
62. Hall CB, Simoes EA, Anderson LJ. Clinical and epidemiologic features of respiratory syncytial virus. Curr Top Microbiol Immunol 2013; 372:39–57.
63. Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med 2001; 163:1723–1729.