Abstract:Palivizumab reduced the incidence of lower respiratory tract infections and hospitalizations due to RSV both in the year of prophylaxis and in the following year. However, this decrease did not have any impact on the development of infants.
“…Moreover, palivizumab showed a favorable safety profile . Another RCT confirmed that the incidence of hospitalization due to RSV was lower in palivizumab recipients both at the year of prophylaxis and in the following year ( P = 0.001, OR 1.32, 95%CI 1.11–1.57) …”
Section: Resultsmentioning
confidence: 90%
“…2 Another RCT confirmed that the incidence of hospitalization due to RSV was lower in palivizumab recipients both at the year of prophylaxis and in the following year (P ¼ 0.001, OR 1.32, 95%CI 1.11-1.57). 14 Severe RSV bronchiolitis has been associated with an increase in subsequent rates of early wheezing, asthma, and possibly allergic sensitization later in life. Palivizumab prevented the recurrent wheeze subsequent to RSV infection: a significant reduction in wheezing days during the first year of life (1.8% palivizumab group vs. 4.5% placebo group), even after the end of palivizumab treatment was reported.…”
Section: Efficacy Of Seasonal Prophylaxis With Palivizumab In Pretermmentioning
“…Moreover, palivizumab showed a favorable safety profile . Another RCT confirmed that the incidence of hospitalization due to RSV was lower in palivizumab recipients both at the year of prophylaxis and in the following year ( P = 0.001, OR 1.32, 95%CI 1.11–1.57) …”
Section: Resultsmentioning
confidence: 90%
“…2 Another RCT confirmed that the incidence of hospitalization due to RSV was lower in palivizumab recipients both at the year of prophylaxis and in the following year (P ¼ 0.001, OR 1.32, 95%CI 1.11-1.57). 14 Severe RSV bronchiolitis has been associated with an increase in subsequent rates of early wheezing, asthma, and possibly allergic sensitization later in life. Palivizumab prevented the recurrent wheeze subsequent to RSV infection: a significant reduction in wheezing days during the first year of life (1.8% palivizumab group vs. 4.5% placebo group), even after the end of palivizumab treatment was reported.…”
Section: Efficacy Of Seasonal Prophylaxis With Palivizumab In Pretermmentioning
“… Fig. 2 RSV-related hospitalization rates in the large randomized controlled trials: a IMpact-RSV [ 24 ], b Carbonell-Estrany et al [ 70 ], c MAKI [ 30 ], d Tavsu et al [ 31 ], e Cardiac [ 23 ], and f Feltes et al [ 71 ] studies. Relative reduction rate compared with placebo is shown as ↓%.…”
Section: Resultsmentioning
confidence: 99%
“…More recently, Tavsu et al [ 31 ] conducted a study from 2009 to 2011 in 80 infants with a GA of <32 weeks in Turkey. These infants were randomized to receive prophylaxis with palivizumab (study group, n = 39) or no prophylaxis (control group, n = 41).…”
Section: Resultsmentioning
confidence: 99%
“… Detailed characteristics of these studies are presented in Appendix Table A1. The Tavsu et al 2014 [ 31 ] trial did not report safety events and was therefore not included in this table AE adverse event, BPD bronchopulmonary dysplasia, CHD congenital heart disease, CLDP chronic lung disease of prematurity, D/C discontinuation of study drug, NA not available, SAE serious adverse event, URTI upper respiratory tract infection a Considered at least possibly related to study drug …”
IntroductionLower respiratory tract infection (LRTI) is the leading cause of infant mortality globally in post-neonatal infants (i.e., 28–364 days of age). Respiratory syncytial virus (RSV) is the most commonly identified pathogen for infant LRTI and is the second most important cause of death in post-neonatal infants. Despite 50 years of RSV vaccine research, there is still no approved vaccine. Therefore, passive immunity with the monoclonal antibody palivizumab is the sole regulatory-approved option for the prevention of serious LRTI caused by RSV in pediatric patients at high risk of RSV disease.MethodsWe conducted a comprehensive systematic literature review of randomized controlled trials (RCTs), open-label non-comparative clinical trials, and prospective observational studies/registries, and summarized the evidence related to the safety, efficacy, and effectiveness of palivizumab.ResultsThe efficacy of palivizumab, as measured by the relative reduction in RSV-related hospitalization rate compared with placebo ranged from 39% to 78% (P < 0.05) in the 2 pivotal RCTs. A meta-analysis of the RSV-related hospitalization rate from 5 randomized placebo-controlled trials yielded an overall odds ratio of 0.41 (95% CI, 0.31–0.55) in favor of palivizumab prophylaxis over placebo (P < 0.00001). Low rates of RSV-related hospitalizations were observed in palivizumab recipients consistently over time in more than 42,000 pediatric subjects across 7 RCTs, 4 open-label non-comparative trials, and 8 observational studies/registries conducted in 34 countries. In addition, among palivizumab-prophylaxed subjects with breakthrough RSV LRTI, rates of intensive care unit admission and mechanical ventilation from RSV hospitalization also were low and consistent across studies. With respect to safety, no differences were observed between palivizumab and placebo in the blinded RCTs.ConclusionRates of RSV hospitalizations and RSV hospitalization-related endpoints in pediatric subjects who received prophylaxis with palivizumab were low and constant over time and across RCTs, open-label non-comparative trials, and observational studies/registries.Electronic supplementary materialThe online version of this article (doi:10.1007/s40121-014-0046-6) contains supplementary material, which is available to authorized users.
ImportanceRespiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infection in children younger than 5 years; effective prevention strategies are urgently needed.ObjectiveTo compare the efficacy and safety of monoclonal antibodies for the prevention of RSV infection in infants and children.Data SourcesIn this systematic review and network meta-analysis, PubMed, Embase, CENTRAL, and ClinicalTrials.gov were searched from database inception to March 2022.Study SelectionRandomized clinical trials that enrolled infants at high risk of RSV infection to receive a monoclonal antibody or placebo were included. Keywords and extensive vocabulary related to monoclonal antibodies, RSV, and randomized clinical trials were searched.Data Extraction and SynthesisThe Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was used. Teams of 2 reviewers independently performed literature screening, data extraction, and risk of bias assessment. The Grading of Recommendations, Assessments, Developments, and Evaluation approach was used to rate the certainty of evidence. A random-effects model network meta-analysis was conducted using a consistency model under the frequentist framework.Main Outcomes and MeasuresThe main outcomes were all-cause mortality, RSV-related hospitalization, RSV-related infection, drug-related adverse events, intensive care unit admission, supplemental oxygen use, and mechanical ventilation use.ResultsFifteen randomized clinical trials involving 18 395 participants were eligible; 14 were synthesized, with 18 042 total participants (median age at study entry, 3.99 months [IQR, 3.25-6.58 months]; median proportion of males, 52.37% [IQR, 50.49%-53.85%]). Compared with placebo, with moderate- to high-certainty evidence, nirsevimab, palivizumab, and motavizumab were associated with significantly reduced RSV-related infections per 1000 participants (nirsevimab: −123 [95% CI, −138 to −100]; palivizumab: −108 [95% CI, −127 to −82]; motavizumab: −136 [95% CI, −146 to −125]) and RSV-related hospitalizations per 1000 participants (nirsevimab: −54 [95% CI, −64 to −38; palivizumab: −39 [95% CI, −48 to −28]; motavizumab: −48 [95% CI, −58 to −33]). With moderate-certainty evidence, both motavizumab and palivizumab were associated with significant reductions in intensive care unit admissions per 1000 participants (−8 [95% CI, −9 to −4] and −5 [95% CI, −7 to 0], respectively) and supplemental oxygen use per 1000 participants (−59 [95% CI, −63 to −54] and −55 [95% CI, −61 to −41], respectively), and nirsevimab was associated with significantly reduced supplemental oxygen use per 1000 participants (−59 [95% CI, −65 to −40]). No significant differences were found in all-cause mortality and drug-related adverse events. Suptavumab did not show any significant benefits for the outcomes of interest.Conclusions and RelevanceIn this study, motavizumab, nirsevimab, and palivizumab were associated with substantial benefits in the prevention of RSV infection, without a significant increase in adverse events compared with placebo. However, more research is needed to confirm the present conclusions, especially for safety and cost-effectiveness.
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