Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Table 6

RSV hospitalization rates within published registries based on specific subpopulations compared to published randomized clinical trials.

Author	Specific subpopulation	*RI hospitalization rate; ^†RSV hospitalization rate	Length of hospital stay in days	RCT	Comments
Parnes et al. [28]; Winterstein et al. [30]; Paes et al. [31]	Cystic fibrosis	^†0.0% (𝑛=12) [28]; *26.2 and ^†3.9/1000 season months [30]; *3.4% and ^†1.14% (𝑛=117) [31]	Undefined [30, 31, 42]	At 6 months follow up RSVH (1.08% [1/92 PB]) [42]	Incomplete RCT [42]-PB (𝑛=92); placebo (𝑛=94)
Parnes et al. [28]; Mitchell et al. [34]; Frogel et al. [37]; Romero [38]; Pedraz et al. [39]; Oh et al. [40]; Lacaze-Masmonteil et al. [41]	Chronic lung disease (CLD)	^†5.8% (𝑛=482) [28]; *10.5% and ^†1.31% (𝑛=449) [34]; ^†2.40% (𝑛= 4,329) [37]; ^†4.0% (𝑛 = NS) [38]; ^†3.9% (𝑛 = NS) [38]; ^†5.5% (𝑛=217, 𝑃<0.007) [39]; ^†3.3% (𝑛=35) [40]; *14.9% (𝑛 = 77); ^†9.0% (𝑛 = 400) [41]	Undefined [15, 28, 34, 37–41]; Overall total days/100 children for treated (PB) patients (≤35 wk GA + CLD): 36.4 (PB) versus 62.6 (Placebo) [15]	𝑛=762. RSVH: 7.9% (PB) versus 12.8% (placebo)-39% reduction [15]	Prevalence of CLD very high compared to other registries (81%) [41]
Parnes et al. [28]; Paes et al. [32]; Mitchell et al. [34]; Frogel et al. [37]; Romero [38]; Pedraz et al. [39]; Lacaze-Masmonteil et al. [41]	All Infants <32 wk; GA [15, 38]; Infants ≤32 wk without CLD [28, 32, 34, 37, 39, 41]	^†4.5% (𝑛=949) [28]; *4.7% and ^†1.5% (𝑛= 5,183) [32]; ^†1.84% (𝑛=7786) [37]; *10.5% and ^†2.8% (𝑛= 1,056) [38]; ^†3.2% (𝑛= 1,446) [38]; †≤28 wk: (1.34%, 𝑛= 1,704) [34], ^†5.4% (𝑛=739, 𝑃<0.001) [39]; ^†29–32 wk: 1.25%, (𝑛=1449) [34]; ^†2.5% (𝑛=1170, 𝑃<0.0000) [39]; ^†7.72% (𝑛=440) [41]	Mean (±SD): 6.7 ± 5.4 [32]; <28 wk (6 ± 2.6) [38], 28–31 wk (14.8 ± 22.8) [38]; ≤32 wk (median 6 [IQR 4–9]) [39]; Undefined [15, 28, 34, 37, 41]	𝑛= 1,111. RSVH: 5.8% (PB) versus 11.0% (placebo)-47% reduction (𝑃=0.003) [15]	IMpact trial [15]; Romero [38] reported on two US outcomes registry cohorts (1998-1999) and (1999-2000). The 2000-2001 cohort is reported by Parnes et al. [28]
Parnes et al. [28]	All infants without CLD [15]	^†2.1% (𝑛= 1,444) [28]	Undefined [15, 28]	𝑛=740. RSVH: 1.8% (PB) versus 8.1% (placebo)-78% reduction [15]	IMpact trial [15]
Frogel et al. [37]; Romero [38]	Premature infants 32–35 wk GA [15, 37, 38]	^†0.83% (𝑛=9294) [37];*2.6% (𝑛=1096) and ^†1.5% (𝑛=548) [38]; ^†1.3% (𝑛=972) [38]	Undefined [15, 37]; Mean (±SD): 4.9 ± 3.6 [38]	𝑛=373. RSVH: 2.0% (PB) versus 9.8% (placebo)-80% reduction (𝑃=0.002) [15]	IMpact trial [15]
Paes et al. [32]; Mitchell et al. [34]; Frogel et al. [37]	Premature infants 32–35 wk GA without CLD [15, 28, 37]; Infants 33–35 wk GA without CLD [32, 34]	^†1.6% (𝑛=936) [28]; *3.7% and ^†1.4% (𝑛= 1,471) [32]; ^†0.2% (𝑛=588) [34]; ^†0.83% (𝑛= 9,294) [37]	Mean (±SD): 5.2 ± 5.0 [32]; Undefined [34, 37]	𝑛=335. RSVH: 1.8% (PB) versus 10.0% (placebo)-82% reduction [15]	IMpact trial [15]
Parnes et al. [28]; Frogel et al. [37]	Infants >35 wk GA	^†0.6% (𝑛=164) [28]; ^†1.13% (𝑛=2390) [37]	Undefined [15, 28, 37]
Mitchell et al. [34]	Hemodynamically significant congenital heart disease (HSCHD) [16, 34]	HSCHD: ^†1.99% (𝑛=508) [34]	Undefined [33]; Total days/100 children: 57.4 (PB) versus 129.0 (Placebo; 56% reduction, 𝑃 = 0.003) [16]	𝑛=1287: 682 (cyanotic), 605 (other). Overall RSVH: 5.3% (PB) versus 9.7% (placebo)-45% reduction. RSVH for cyanotic group: 5.6% (PB) versus 7.9% (placebo)-29% reduction (𝑃=0.285). RSVH for “acyanotic group”: 5.0% (PB) versus 11.8% (placebo)-58% reduction (𝑃=0.003) [16]	Feltes et al. [16]. All patients had hemodynamically significant CHD. Study was not powered for subgroup analyses. Incidence of serious adverse events was lower in the treatment arm: 55.4% (PB) versus 63.1% (placebo; 𝑃=0.005)

CHD: congenital heart disease; CLD: chronic lung disease; GA: gestational age; HSCHD: hemodynamically significant congenital heart disease; NS: not specified; PB: palivizumab; RI: respiratory related hospitalization; RSVH: respiratory syncytial related hospitalization.