Nirsevimab safe, effective vs. RSV-related LRTI in children
31 May 2024
This study, a meta-analysis and systematic review, was conducted by researchers Mapili and colleagues from the University of the Philippines, with the aim of providing data on nirsevimab’s safety and efficacy in RSV-associated LRTI prevention [Front. Pediatr. 2023; 11:1132740]
The researchers performed a meta-analysis comparing nirsevimab injection given before RSV season vs. placebo among infants. The team searched for relevant trials from database inception to June 2022 using search engines - Scopus, MEDLINE, CENTRAL, and ClinicalTrials.gov. Two studies, meeting the inclusion criteria, were included in the meta-analysis. The selected studies were evaluated for risk of bias using the Revised Cochrane Risk-of-Bias (RoB2) tool. The quality of evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Statistical analyses were conducted using Review Manager version 5.4 from Cochrane. The relevant data from each study were presented using Forest plots.
Evidence on nirsevimab’s efficacy was gathered in the review, in terms of preventing RSV-related LRTI and reducing the incidence of hospitalizations. The meta-analysis revealed a significant 74 percent decrease in medically-managed RSV-associated LRTI (RR: 0.26; 95% CI: 0.18–0.38). The risk of RSV-associated LRTI hospitalizations, on the other hand, was reduced by 76 percent (RR: 0.24; 95% CI: 0.13–0.47). Considering these results, nirsevimab exhibited remarkable efficacy as a preventive treatment against severe RSV-related LRTI.
In terms of safety, the meta-analysis showed no significant increase in the incidence of fatal adverse events (RR: 0.78, 95% CI: 0.20–2.98) and no increase in the risk of adverse events of special interest, which includes immune complex disease, hypersensitivity, or thrombocytopenia (RR: 0.92, 95% CI: 0.25–3.38). Based on these findings, nirsevimab is well-tolerated and does not constitute a significant safety concern.
It is important to note that a limitation of the study is the potential exclusion of more recent and ongoing research, according to Turalde et al. This is due to the time frame of data gathered which is from the inception of databases until June 2022. Similarly, unpublished studies, they said, are not included in the meta-analysis, since the mode of data gathering is through pre-specified search engines. They recommended additional research to validate their findings and to explore nirsevimab’s long-term effects. In terms of education and training, the authors emphasized the need to establish systems to minimize lag time from evidence publication to incorporation of the information to textbooks. Such systems will enable students and post-graduate trainees to access updated evidence for their treatment decisions.
Overall, the study provides affirmative evidence regarding the efficacy and safety of nirsevimab in preventing RSV-associated LRTI and reducing hospitalizations in vulnerable populations, such as infants and young children.
Although further research is warranted to validate these findings and to investigate the long-term effects of nirsevimab treatment, this meta-analysis study offers valuable insights into the advantages and benefits of this novel treatment option, setting a clinical and research foundation for healthcare professionals in RSV disease prevention and management strategies.
The researchers performed a meta-analysis comparing nirsevimab injection given before RSV season vs. placebo among infants. The team searched for relevant trials from database inception to June 2022 using search engines - Scopus, MEDLINE, CENTRAL, and ClinicalTrials.gov. Two studies, meeting the inclusion criteria, were included in the meta-analysis. The selected studies were evaluated for risk of bias using the Revised Cochrane Risk-of-Bias (RoB2) tool. The quality of evidence was evaluated using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Statistical analyses were conducted using Review Manager version 5.4 from Cochrane. The relevant data from each study were presented using Forest plots.
Evidence on nirsevimab’s efficacy was gathered in the review, in terms of preventing RSV-related LRTI and reducing the incidence of hospitalizations. The meta-analysis revealed a significant 74 percent decrease in medically-managed RSV-associated LRTI (RR: 0.26; 95% CI: 0.18–0.38). The risk of RSV-associated LRTI hospitalizations, on the other hand, was reduced by 76 percent (RR: 0.24; 95% CI: 0.13–0.47). Considering these results, nirsevimab exhibited remarkable efficacy as a preventive treatment against severe RSV-related LRTI.
In terms of safety, the meta-analysis showed no significant increase in the incidence of fatal adverse events (RR: 0.78, 95% CI: 0.20–2.98) and no increase in the risk of adverse events of special interest, which includes immune complex disease, hypersensitivity, or thrombocytopenia (RR: 0.92, 95% CI: 0.25–3.38). Based on these findings, nirsevimab is well-tolerated and does not constitute a significant safety concern.
It is important to note that a limitation of the study is the potential exclusion of more recent and ongoing research, according to Turalde et al. This is due to the time frame of data gathered which is from the inception of databases until June 2022. Similarly, unpublished studies, they said, are not included in the meta-analysis, since the mode of data gathering is through pre-specified search engines. They recommended additional research to validate their findings and to explore nirsevimab’s long-term effects. In terms of education and training, the authors emphasized the need to establish systems to minimize lag time from evidence publication to incorporation of the information to textbooks. Such systems will enable students and post-graduate trainees to access updated evidence for their treatment decisions.
Overall, the study provides affirmative evidence regarding the efficacy and safety of nirsevimab in preventing RSV-associated LRTI and reducing hospitalizations in vulnerable populations, such as infants and young children.
Although further research is warranted to validate these findings and to investigate the long-term effects of nirsevimab treatment, this meta-analysis study offers valuable insights into the advantages and benefits of this novel treatment option, setting a clinical and research foundation for healthcare professionals in RSV disease prevention and management strategies.