Table 5: Patient populations and outcomes of RSV prophylaxis across published registries.

Author/year/countryStudy designCharacteristics of patients— Overall RSV hospitalization rateComments

Winterstein et al. [30]/2012/USANational CF registry. Case control (1999–2006)1,974 CF patients aged 0–2 yr over 2,875 patient seasons. Treated (PZ) compared to nontreated group32 RSV-related hospitalizations. Adjusted HR for RSVH: 0.57 (95% CI; 0.2–1.6)
Adjusted incidence rate: PZ, 2.4 (95% CI 0.8–6.6)
Low event rate. Only serious RSV illness was captured. Potential confounders

Paes et al. [31]/2012/CanadaCARESS registry-prospective, observational (2006–2010)All treated (PZ). 4,880 infants ≤35 wk gestational age (GA) (group 1) compared to 952 with spectrum of medical disorders (MD; group 2)RSVH: 1.3% versus 2.4% ( ) but ranged from 0.78% to 11.8% based on MD type. Hazard for RSVH was similar in both groupsHigher severity of illness in group 2. No control group. Study patients included only those approved for (PZ)

Paes et al. [32]/2012/CanadaCARESS registry-prospective, observational (2006–2011)All treated (PZ). 5,183 ≤ 32 wk GA (group 1) versus 1,471 33–35 wk GA (group 2) RSVH rates were similar (1.5% (Group 1) versus 1.4% (Group 2); ). Hazard for RSVH was similar in both groupsNo control group. Only moderate-high risk 33–35 wk infants were evaluated.

Mitchell et al. [34]/2011/CanadaCARESS registry-prospective, observational (2005–2009)All treated (PZ). Total 5,286 infants: 3,741 (premature); 449 (CLD); 508 (HSCHD); 588 (other MD)Overall RSVH was 1.38%: premature (1.12%); BPD (1.31%); HSCHD (1.99%); MD (2.78%)No control group. Only patients approved for (PZ) were studied.

Simon et al. [33]/2011/GermanyGerman registry-observational (2002–2007)All treated (PZ). 10,686 enrolled: evaluable patients 6,967 (<33 wk GA); 1500 (33–35 wk GA); 481 (>35 wk GA)RSVH in worst-case scenario—2.5%No control group. Not all patients were included and RSV tested. Possible missing data.

Frogel et al. [35]/2008/USAPalivizumab outcomes registry-prospective, observational (2000–2004)All treated (PZ). Total 19,548 infants, 19,474 with followup. PZ administered at home (1,226) versus clinic/office (17,641): 7,517 (<32 wk GA); 9,061 (32–35 wk GA); 2,285 (>35 wk GA)RSVH: Home: 0.4%; clinic: 1.2%, . Highest rate found in patients with mixed settings (5.8%)No control group. Potential confounders were identified.

Cohen et al. [36]/2008/USAPalivizumab outcomes registry-prospective, observational (2000–2004)All treated (PZ). Total 19,548 infants. 1067 (acyanotic), 428 (cyanotic) CHD. 32.3% had HSCHD (485/1500). 468 (<32 wk GA); 327 (32–35 wk GA); 705 (>35 wk GA). Of these 448 also had CLD and 5 had CF.Overall RSVH: 1.9% (all CHD); 1.6% (acyanotic); 2.6% (cyanotic)No control group. 67.7% did not have HSCHD. Event rate possibly was underestimated.

Frogel et al. [37]/2008/USAPalivizumab outcomes registry-prospective, observational (2000–2004)All treated (PZ): Total 19,548 patients, 19,474 with follow-up. 7826 (<32 wk GA); 9,317 (32–35 wk GA); 2400 (>35 wk GA). Of these 4,349 (CLD); 1500 (CHD); 91 (CF)Overall RSVH was 1.3%. <32 wk GA: 1.84; 32–35 wks GA: 0.83; >35 wk GA: 1.13. RSVH decreased in each subgroup from 2000 to 2004No control group. Possible underestimation of event rate.

Parnes et al. [28]/2003/USAPalivizumab outcomes registry-prospective, observational (2000-2001)All treated (PZ). Total 2,116 infants: 986 (<32 wk GA); 957 (32–35 wk GA); 172 (>35 wk GA). Of these 500 (CLD); 102 (CHD); 12 (CF)Overall RSVH: 2.9%. RSVH rate: 2.1% (prematurity without CLD); 4.3% (CHD); 5.8% (CLD)No control group. 97% followup was achieved. 6% of infants >35 wk had no CLD

Romero [38]/2003/USAPalivizumab outcomes registry-prospective, observational (1998–2002)All treated (PZ). Total 4,669 infants (1998–2000) and 5,091 (2001-2002). Data for 2000-2001 [9]Overall RSVH 2.3%; (1998-1999), 2.4% (1999-2000), 1.5% (2001-2002)No control group

Pedraz et al. [39]/2003/SpainSpanish registry (IRIS) case control (1998–2002)Untreated ( ; 1998–2000) versus treated (PZ; ; 2000–2002)RSVH: control (13.25%); PZ (3.95%)

Oh et al. [40]/2002/CanadaCanadian Therapeutic Products Program-prospective, observational (1999-2000)All treated (PZ). Total 444/480 evaluable infants: Premature (345); CLD (40); both CLD and prematurity (68); others (27)Overall RSVH (2.4%). RSVH in premature infants (1.6%); CLD (6.0%)No control group. All patients were not tested for RSV and sampling method was not specified.

Lacaze-Masmonteil et al. [41]/2002/FranceFrench Drug agency-prospective, observational study (1999-2000)All treated (PZ). Total 516 infants (499 evaluable); 258 (<28 wk GA), 182 (29–32 wk GA), 31 (33–35 wk GA), 28 (>35 wk GA).Overall RSVH (8.1%)High proportion of infants had CLD (81%) which possibly influenced RSVH.

CF: cystic fibrosis; CHD: congenital heart disease; CLD: chronic lung disease; HR: hazard ratio; HSCHD: hemodynamically significant congenital heart disease; PZ: palivizumab; RSVH: respiratory syncytial virus-related hospitalization.