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SYNAGIS®: Proven protection against
severe RSV disease for more than 25 years1
Two pivotal trials included nearly
2800 of the most vulnerable patients1-3:
IMpact-RSV TRIAL Preterm infants with and without BPD FELTES TRIAL Children with HS-CHD
SYNAGIS: PROVEN TO PROTECT PRETERM INFANTS WITH AND WITHOUT BPD1,2
Primary analysis
SYNAGIS significantly reduced RSV hospitalizations by
55%
in preterm infants with
and without BPD1,2
(RSVH rate 10.6% with placebo vs 4.8%
with SYNAGIS; P<0.001)
Primary analysis:
Preterm infants with and without BPD2
Study Design
1502 patients were randomized in the IMpact-RSV trial.2
740 preterm infants
≤35 wGA without BPD
762 children
≤24 months of age
with BPD
A multicenter, randomized, placebo-controlled trial in infants born at ≤35 wGA and ≤6 months of age or children with BPD ≤24 months of age randomized 2:1 to receive 1 injection of palivizumab (15 mg/kg) (n=1002) or an equal volume of placebo (n=500) every 30 days for a total of 5 doses.2
Primary group analysis
SYNAGIS showed a significant reduction in RSV hospitalizations in each of the primary inclusion groups1,2*
78%
reduction in RSVH in preterm infants ≤35 wGA
(RSVH rate 8.1% with placebo vs 1.8% with SYNAGIS; P<0.001)
39%
reduction in RSVH in children with BPD <24 months of age
(RSVH rate 12.8% with placebo vs 7.9% with SYNAGIS; P=0.038)
*The prespecified primary inclusion populations in the IMpact-RSV trial were preterm infants ≤35 wGA and ≤6 months of age and children with BPD ≤24 months of age.2
Subgroup analysis
SYNAGIS reduced RSV hospitalizations by
72%
among very preterm infants4†
(RSVH rate 6.5% with placebo vs 1.8%
with SYNAGIS)
Subgroup analysis:
Very preterm infants <32 wGA without BPD4
Secondary Endpoints
SYNAGIS significantly reduced RSVH severity in preterm infants with and without BPD.2‡
42%
fewer days of RSV hospitalization
(per 100 children: 62.6 days with placebo vs 36.4 days with SYNAGIS; P<0.001)
57%
lower rate of ICU admissions
(3.0% with placebo vs 1.3% with SYNAGIS; P=0.026)
40%
fewer days with increased supplemental oxygen
(per 100 children: 50.6 days with placebo vs 30.3 days with SYNAGIS; P<0.001)
†Subgroup analyses should be interpreted with caution due to their inherent limitations and results from these analyses may differ from those observed in clinical practice.
‡The placebo and SYNAGIS groups did not show significant differences in incidence of mechanical ventilation (0.2% vs 0.7%, P=0.280) or total days of mechanical ventilation (1.7 days vs 8.4 days, P=0.210). ICU total days were 12.7 with placebo and 13.3 with SYNAGIS (P=0.023).2
Most frequently reported adverse events2§
that were judged to be potentially related to study drug
Placebo (n=500) | SYNAGIS (n=1002) | |
Fever | 3.0% | 2.8% |
Nervousness | 2.6% | 2.5% |
Injection-site reaction | 1.6% | 2.3% |
Diarrhea | 0.4% | 1.0% |
§Reported events in at least 1% of children in the palivizumab group are provided along with the corresponding incidence in the placebo group. These represent adverse events reported by the investigator and include those identified by protocol-mandated testing and other clinically indicated evaluations.2
SYNAGIS: PROVEN TO PROTECT CHILDREN WITH HS-CHD1,3
Primary endpoint analysis
SYNAGIS significantly reduced RSV hospitalizations by
45%
among children ≤24 months of age with HS-CHD1,3
(RSVH rate 9.7% with placebo vs 5.3%
with SYNAGIS; P=0.003)
Primary endpoint analysis:
Children ≤24 months of age with HS-CHD3
Study Design
1287 children with HS-CHD were randomized in the Feltes trial.3
A randomized, double-blind, placebo-controlled trial of 1287 children ≤24 months of age with hemodynamically significant CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of SYNAGIS 15 mg/kg or placebo. The study was conducted during 4 consecutive RSV seasons at 76 centers in the United States (n=47), Canada (n=6), Sweden (n=3), Germany (n=4), Poland (n=6), France (n=4), and the United Kingdom (n=6). Each child participated during only one RSV season. Results may not be generalizable to a US population.3
Secondary Endpoints
SYNAGIS significantly reduced RSVH severity in children with HS-CHD.3II
56%
fewer total days of RSV-related hospitalizations
(per 100 children: 129 days with placebo vs 57.4 days with SYNAGIS; P<0.003)
57%
fewer total days with increased supplemental oxygen
(per 100 children: 101.5 days for placebo vs 27.9 days with SYNAGIS; P<0.014)
IIThe placebo and SYNAGIS groups did not show statistically significant differences in incidence of RSV-related ICU admissions (3.7% vs 2.0%, P=0.094), total days of RSV-related ICU stays per 100 children (71.2 days vs 15.9 days, P=0.80), incidence of RSV-related mechanical ventilation (2.2% vs 1.3%, P=0.282), or total days of RSV-related mechanical ventilation per 100 children (54.7 days vs 6.5 days, P=0.224).3
Most frequently reported adverse events3¶
that were judged to be potentially related to study drug
Placebo (n=648) | SYNAGIS (n=639) | |
Fever | 23.9% | 27.1% |
Infection | 2.9% | 5.6% |
Injection-site reaction | 2.2% | 3.4% |
Upper respiratory infection | 46.1% | 47.4% |
Conjunctivitis | 9.3% | 11.3% |
Arrythmia# | 1.7% | 3.1% |
Cyanosis# | 6.9% | 9.1% |
¶Few adverse events were reported at an absolute incidence >1% higher in the SYNAGIS group compared with the placebo group.3
#None of these events reported as arrhythmia and one reported as cyanosis (placebo recipient) were judged related to the study drug.3
BPD=bronchopulmonary dysplasia; CHD=congenital heart disease; HS-CHD=hemodynamically significant congenital heart disease; ICU=intensive care unit; RSV=respiratory syncytial virus; RSVH=respiratory syncytial virus hospitalization; wGA=weeks gestational age.
REFERENCES: 1. SYNAGIS (palivizumab) [prescribing information]. Waltham, MA: Sobi, Inc. 2021. 2. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3):531-537. 3. Feltes TF, Cabalka AK, Meissner HC, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003;143(4):532-540. 4. Data on file. Sobi, Inc.
All imagery is for illustrative purposes only.
ALL INFANTS ARE NOT THE SAME
SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:
The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.
SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:
The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.
Previous significant hypersensitivity reaction to SYNAGIS.
Hypersensitivity Reactions: Anaphylaxis and anaphylactic shock (including fatal cases) and other severe acute hypersensitivity reactions have been reported. Permanently discontinue SYNAGIS and administer appropriate medication if such reactions occur.
Coagulation Disorders: SYNAGIS should be given with caution to children with thrombocytopenia or any coagulation disorder.
RSV Diagnostic Test Interference: Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.
Serious Adverse Reactions: The most common serious adverse reactions occurring with SYNAGIS are anaphylaxis and other acute hypersensitivity reactions.
Most Common Adverse Reactions: The most common adverse reactions are fever and rash.
Postmarketing Experience: Severe thrombocytopenia and injection site reactions have been identified during post approval use of SYNAGIS.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These are not all the possible risks associated with SYNAGIS. Please see full Prescribing Information for SYNAGIS, including Patient Information. To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or the FDA at 1-800-FDA-1088.
For Statutory Pricing Disclosure, visit synagishcp.com/wac-pricing.
