Review Article

Effectiveness of Palivizumab in Preventing RSV Hospitalization in High Risk Children: A Real-World Perspective

Table 1

Studies on effectiveness of palivizumab in reducing RSV-associated hospitalization in premature infants with or without congenital lung disease (CLD).

Author, year, and location Study designTimelineStudy populationIntervention strategySample sizeRSV hospitalization ratesConclusionQuality of study

(1) Sorrentino and Powers, 2000, USA [33]Retrospective chart review1998-1999 Premature infants with GA ≤ 35 weeks and age <2 years with CLDPalivizumab only1839Infants without CLD = 2.1%,
with CLD = 4.0%, and
with CF = 0%
Hospitalization rates in prophylaxed children were similar to rates in prophylaxed children from IMpact-RSV trial [3]Low

(2) Singleton et al., 2003, Alaska [26]Cohort study 1993–2001Premature infants GA < 36 weeks Prepalivizumab era (1993–1996) versus postpalivizumab era (1998–2001)Prepalivizumab era: 992
Postpalivizumab era: 1087
Prepalivizumab era = 439/1000 births
Palivizumab era = 150/1000 births
()
The rate decreased by 3-fold with palivizumab Moderate

(3) Pedraz et al., 2003, Spain [27]Cohort study 1998–2000 and 2000–2002 Premature infants with GA ≤ 32 without CLD and children aged <2 years with CLDPrepalivizumab era (1998–2000) versus postpalivizumab era (2000–2002)Nonprophylaxed group: 1583
Prophylaxed group: 1919
Infants ≤ 28 week GA:
nonprophylaxed = 13%,
prophylaxed = 5.4%
()
Infants 29–32 week GA:
nonprophylaxed = 9.9%,
prophylaxed = 2.5%
()
Infants with CLD:
nonprophylaxed = 19.7%,
prophylaxed = 5.5%
()
Effective for children with GA ≤ 32 weeks and for children with CLDModerate

(4) Lacaze-Masmonteil et al., 2004, France [29]Cohort study 2000-2001Premature infants with <33 week GA No palivizumab versus palivizumab Nonprophylaxed group: 2370
Prophylaxed group: 376
Nonprophylaxed = 20.1%
Prophylaxed = 8.4%
()
Protective benefits for infants with GA < 33 weeks Low

(5) Parnes et al., 2003, USA [34]Record review2000-2001All children eligible for palivizumab according to AAP guidelines [40]Received at least one dose of palivizumab2116
GA < 32 weeks: 986 (46.6%)
GA 32– 35 weeks: 957 (45.2%)
GA >35 weeks: 172 (8.1%)
All infants = 2.9%
Infants with CLD = 5.8%
Infants < 32 weeks of GA = 4.5%
Infants > 35 weeks of GA = 0.6%
RSV hospitalization rates lower compared to rate of 13% in nonprophylaxed children from Spain [8] Low

(6) Henckel et al., 2004, Sweden [30]Cohort study 1992–2002 Preterm infants with CLD and age < 2 years and extreme preterm infants No palivizumab versus Palivizumab Nonprophylaxed group: 61,990 
Prophylaxed group: 235
Infants with CLD:
nonprophylaxed = 6.8%,
prophylaxed = 7.3%
()
Infants with GA < 33 weeks:
nonprophylaxed = 3.9%,
prophylaxed = 2.7%
()
Use of palivizumab may be restricted to very preterm infants (GA < 26 weeks) suffering from severe CLDLow

(7) Singleton et al., 2006, Alaska [28]Cohort study 1994–1997 and 2001–2004 Premature infants GA < 36 weeksPrepalivizumab era (1994–1997) versus postpalivizumab era (2001–2004) 2555 childrenPrepalivizumab era = 317/1000 births/year
Palivizumab era = 123/1000 births/year
()
Palivizumab reduced hospitalization rate in premature infantsLow

(8) Mitchell et al., 2006, Canada [23]Cohort study1995–2002All premature infants Prepalivizumab era (1995–1998) versus postpalivizumab era (1999–2002) (in Calgary palivizumab was introduced in 1999 whereas in Edmonton palivizumab was not administered) Calgary: 2,876
GA 33–35 weeks:
prepalivizumab era: 907,
postpalivizumab era: 842
GA < 33 weeks or with CLD: prepalivizumab era: 411,
postpalivizumab era: 496
Edmonton: 2,467
GA 33–35 weeks:
prepalivizumab era: 787,
postpalivizumab era: 834
GA < 33 weeks or with CLD: prepalivizumab era: 401,
postpalivizumab era: 425
Edmonton = 7.1%
Calgary = 2.9% ()
Calgary
Infants with GA < 33 weeks or GA 33–35 weeks with CLD:
prepalivizumab era = 7.3%,
postpalivizumab era 3.0%
()
Infants with GA 33–35 weeks and born within 6 months of RSV season or at the start of RSV season:
prepalivizumab era = 3.3%,
postpalivizumab era = 2.7%
()
Edmonton
Infants with GA < 33 weeks or GA 33–35 weeks with CLD:
prepalivizumab era = 5.0%,
postpalivizumab era = 7.0% ()
Infants with GA 33–35 weeks:
prepalivizumab era = 4.1%,
postpalivizumab era = 2.1%
()
Effective for infants with GA < 33 weeks with other comorbidities
Could be upgraded to moderate
Moderate

(9) Kusuda et al., 2006, Japan [25]Nonrandomised questionnaire survey2002-2003All premature infants born at GA ≤ 35 weeks and infants with CLD No palivizumab versus palivizumab Nonprophylaxed group: 41
Prophylaxed group: 35
Nonprophylaxed group = 1.3%
Prophylaxed group = 1.4%
Small sample size to determine conclusive resultVery low

(10) Grimaldi et al., 2007, France [31]Cohort study 1999–2004 Premature infants with GA ≤ 30 weeks without BPD Prepalivizumab era (1999–2002) versus postpalivizumab era (2002–2004) Prepalivizumab era: 118
Postpalivizumab era: 88
Prepalivizumab era = 13.5%
Postpalivizumab era = 1.1%
()
Palivizumab reduced hospitalization rate Low

(11) Chang et al., 2010, Korea [36]Hospital record review2004–2009Children were born at ≤35 weeks of GA, were <2 years of age, and had received medical therapy for CLDNo palivizumab versus palivizumab Nonprophylaxed group: 53
Prophylaxed group: 75
Nonprophylaxed group = 22.6%
Prophylaxed group = 4.0%
()
Palivizumab reduced RSV hospitalization in children with CLD Low

(12) Paes et al., 2012, Canada [35] Cohort study2006–2011Group 1: premature infants GA ≤ 32 weeks without preexisting medical disorders
Group 2: premature infants GA 33–35 completed weeks
Comparison between prophylaxed Group 1 and prophylaxed Group 2 Group 1: 5,183
Group 2: 1,471
Group 1 = 1.5%
Group 2 = 1.4%
()
Palivizumab prophylaxis beneficial for infants with 33–35 week GA but should be country-specific Low