Table 3.
RSV-associated hospitalizations and related efficacy endpoints in the prospective observational studies/registries
| Population | Study | RSV-associated hospitalization | RSV ICU admission | Mechanical ventilation | ||||
|---|---|---|---|---|---|---|---|---|
| Incidence, % of N | Total days, mean ± SD | Days with increased supplemental oxygen, mean ± SD | % Subjects | Total days, mean ± SD | % Subjects | Total days, mean ± SD | ||
| BPD/CLDP or prematurity | Pedraz et al. [45] | Nonprophylaxed: 13.25 of 1,583 | Median (IQR), 8 (5, 11) | NA | 2.1 | NA | 0.8 | NA |
| Palivizumab: 3.95 of 1,919 | Median (IQR), 6 (4, 9) (P < 0.01) | 0.5 | 0.4 | |||||
| BPD/CLDP | Pedraz et al. [45] | Nonprophylaxed: 19.7 of 71 | NA | NA | NA | NA | NA | NA |
| Palivizumab: 5.5 of 217 (P < 0.007) | ||||||||
| French ATU Program [42] | 9.0 of 400 | NA | NA | NA | NA | NA | NA | |
| Palivizumab Outcomes Registry [41] | 2.40 of 4,329 | NA | NA | NA | NA | NA | NA | |
| CARESS (2005–2009)a [26] | 1.31b of 449 | NA | NA | NA | NA | NA | NA | |
| Prematurity | ||||||||
| ≤28 weeks GA | Pedraz et al. [45] | Nonprophylaxed: 13.0 of 246 | NA | NA | NA | NA | NA | NA |
| Palivizumab: 5.4 of 739 (P < 0.0001) | ||||||||
| French ATU Program [42] | 5.8 of 258 | NA | NA | NA | NA | NA | NA | |
| CARESS (2005–2009)c [26] | 1.34b of 1,704 | NA | NA | NA | NA | NA | NA | |
| 29–32 weeks GA | Pedraz et al. [45] | Nonprophylaxed: 9.9 of 1,297 | NA | NA | NA | NA | NA | NA |
| Palivizumab: 2.5 of 1,170 (P < 0.0000) | ||||||||
| French ATU Program [42] | 10.4 of 182 | NA | NA | NA | NA | NA | NA | |
| CARESS (2005–2009)a [26] | 1.25b of 1,449 | NA | NA | NA | NA | NA | NA | |
| <32 weeks GA | Palivizumab Outcomes Registry [41] | 1.84 of 7,786 | NA | NA | NA | NA | NA | NA |
| ≤32 weeks GA | Canadian Special Access Programme [44] | 1.6b of 324 | NA | NA | NA | NA | NA | NA |
| CARESS (2006–2011)a [28] | 1.5b of 5,183 | 6.7 ± 5.4 | 0.5 ± 2.2 | 0.3 | 1.2 ± 2.7 | 0.3 | 1.3 ± 2.9 | |
| 32–35 weeks GA | Palivizumab Outcomes Registry [41] | 0.83 of 9,294 | NA | NA | NA | NA | NA | NA |
| 33–35 weeks GA | CARESS (2005–2009)a [26] | 0.2b of 588 | NA | NA | NA | NA | NA | NA |
| CARESS (2006–2011)a [28] | 1.4b of 1,471 | 5.2 ± 5.0 | 0.2 ± 0.9 | 0.3 | 1.3 ± 2.4 | 0.3 | 0.3 ± 1.8 | |
| <35 weeks GA | Lesnick et al. [43] | 1.0 of 2,838 | NA | NA | NA | NA | NA | NA |
| ≤35 weeks GA | CARESS (2005–2009)a [26] | 1.12b of 3,741 | NA | NA | NA | NA | NA | NA |
| CARESS (2006–2010)a [27] | 1.3b of 4,880 | 7.3 ± 6.9 | 0.7 ± 2.9 | 0.3 | 1.7 ± 3.7 | 0.2 | 1.0 ± 3.1 | |
| CHD | Palivizumab Outcomes Registry [41] | 1.88 of 1,490 | NA | NA | NA | NA | NA | NA |
| CARESS (2005–2009)a [26] | 1.99b of 508 | NA | NA | NA | NA | NA | NA | |
| All prescribed | French ATU Program [42] | 7.6c of 516 | NA | NA | 1.9 | NA | 0.8 | NA |
| Canadian Special Access Programme [44] | 2.4b of 444 evaluable | 5.5 ± 3.8 | NA | NA | NA | NA | NA | |
| Lesnick et al. [43] | 0.8 of 3,520 | NA | NA | NA | NA | NA | NA | |
| Golombek et al. [72] | 1.17 of 1,446 overall (3.57 of 224 physician’s office setting; 0.93 of 969 home setting) | NA | NA | NA | NA | NA | NA | |
| Palivizumab Outcomes Registry [41] | 1.3 of 19,474d evaluable | NA | NA | NA | NA | NA | NA | |
| German Palivizumab Registry [46] | 1.6c of 9,833 evaluable | NA | NAc | 0.5 | NA | 0.1 | NA | |
| CARESS (2005–2009)d [26] | 1.38b of 5,286 | 8.0 ± 6.8 | 0.9 ± 3.1 | NA | 2.4 ± 4.5 | NA | 2.0 ± 4.1 | |
| Congenital airway abnormality/severe neuromuscular disease | Palivizumab Outcomes Registry [41] | 2.14 of 1,122 | NA | NA | NA | NA | NA | NA |
| >35 weeks GA and non-BPD/CHD medical disorders | CARESS (2006–2010)a [27] | 2.4b of 952 | 7.3 ± 5.8 | 1.6 ± 3.6 | 0.8 | 3.3 ± 5.4 | 1.3 | 3.6 ± 5.0 |
| >35 weeks GA | Palivizumab Outcomes Registry [41] | 1.13 of 2,390 | NA | NA | NA | NA | NA | NA |
| Other | CARESS (2005–2009)a [26] | 2.78b of 592 | NA | NA | NA | NA | NA | NA |
Detailed characteristics of these studies are presented in Appendix Table A1. Pedraz et al. 2003 [45] was a prospective, observational, case-controlled study; all other studies were prospective observational studies/registries. For all studies, results for subgroups with <100 palivizumab-prophylaxed patients were not reported here because of the small numbers
BPD bronchopulmonary dysplasia, CHD hemodynamically significant congenital heart disease, CLDP chronic lung disease of prematurity, ICU intensive care unit, IQR interquartile range, GA gestational age, NA not available, RSV respiratory syncytial virus
aSome reported patient populations may overlap
bRSV hospitalization rate = hospitalization rate × (subjects RSV positive/subjects tested)
cRSV hospitalization rate = hospitalization rate × (subjects RSV positive/subjects tested) was 8.1% for the French ATU Program [42] and 2.5% for the German Palivizumab Registry [46]
d1,047 subjects were enrolled for >1 season and were counted as separate enrollments per season enrolled