RSV: UK to examine whether to offer monoclonal antibody routinely to all babies

Wise, Jacqui

doi:10.1136/bmj.o2725

Cited by 5 publications

(6 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Respiratory syncytial virus (RSV) is a common seasonal cause of acute lower respiratory tract infection (LRTI) in young children, 1 and a leading cause of infant hospitalizations. [2][3][4][5] A novel RSV-neutralizing monoclonal antibody, nirsevimab, has recently been approved in the EU (2022), UK (2022), Canada (2023), and the USA (2023), [6][7][8][9] to prevent RSV lower respiratory tract disease in neonates and infants during their first RSV season. The safety and efficacy of nirsevimab in protecting against medically attended RSV LRTIs was demonstrated in a placebo-controlled phase IIb study 10 and phase III (MELODY) study 11,12 in healthy preterm and term infants (i.e., those not currently eligible for RSV prophylaxis with palivizumab) in their first RSV season.…”

Section: Introductionmentioning

confidence: 99%

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

Drysdale,

Cathie,

Flamein

et al. 2023

N Engl J Med

View full text Add to dashboard Cite

Background: This pragmatic trial assessed the safety and impact of the monoclonal antibody nirsevimab on hospitalizations associated with RSV lower respiratory tract infection (LRTI) in healthy infants.Methods: Infants ≤12 months old, born ≥29 weeks gestational age entering their first RSV season in France, Germany and the UK were randomized 1:1 to receive a single intramuscular injection of nirsevimab or no intervention (standard-of-care) before/during the RSV season. Participants were monitored remotely for RSV LRTI hospitalization (defined as in-patient care with confirmed RSV) and very severe RSV LRTI (defined as RSV LRTI hospitalization with oxygen saturation <90% and requiring oxygen supplementation) through the RSV season.Results: 8,058 participants were randomized: 4,037 to the nirsevimab group and 4,021 to no intervention. Eleven (0.3%) RSV LRTI hospitalizations occurred in the nirsevimab group and 60 (1.5%) in the no intervention group, giving an efficacy of 83.2% (95% CI: 67.8 to 92.0; P<0.001). Very severe RSV LRTI occurred in five (0.1%) participants in the nirsevimab group and 19 (0.5%) in the no intervention group, giving an efficacy of 75.

show abstract

Section: Introductionmentioning

confidence: 99%

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

Drysdale,

Cathie,

Flamein

et al. 2023

N Engl J Med

View full text Add to dashboard Cite

show abstract

“…Nirsevimab, a new monoclonal antibody, has been approved for the prevention of RSV‐associated LRTI in both preterm and full‐term infants during their first RSV season 9–12 . It has shown greater potency in reducing RSV infection and a more extended half‐life than palivizumab 13 .…”

Section: Introductionmentioning

confidence: 99%

“…5,8 Nirsevimab, a new monoclonal antibody, has been approved for the prevention of RSV-associated LRTI in both preterm and full-term infants during their first RSV season. [9][10][11][12] It has shown greater potency in reducing RSV infection and a more extended half-life than palivizumab. 13 Clinical trials revealed a decrease in the incidence of RSV-LRTI and hospitalization after a single intramuscular dose of nirsevimab, exhibiting a favorable safety profile.…”

mentioning

confidence: 99%

Nirsevimab immunization's real‐world effectiveness in preventing severe bronchiolitis: A test‐negative case–control study

Agüera,

Soler‐Garcia,

Alejandre

et al. 2024

Pediatric Allergy Immunology

View full text Add to dashboard Cite

BackgroundSeveral clinical trials have shown that nirsevimab, an antibody targeting the respiratory syncytial virus (RSV), reduces RSV bronchiolitis requiring admission. In 2023–2024, Catalonia and Andorra adopted immunization strategies for children <6 months and those born during the epidemic season. This study evaluates the effectiveness of nirsevimab in preventing hospitalizations from RSV bronchiolitis.MethodsIn the epidemic season of 2023–2024, a test‐negative case–control study was conducted in three hospitals from Catalonia and Andorra. Patients <12 months old admitted with bronchiolitis and tested for RSV using molecular microbiology tests were included.The effectiveness in preventing RSV bronchiolitis hospitalization and severe disease was estimated using multivariate models. Comparisons between immunized, non‐immunized, and non‐eligible patients were made in prospectively collected epidemiological, clinical, and microbiological variables.ResultsTwo hundred thirty‐four patients were included. RSV was detected in 141/234 (60.2%), being less common in the immunized group (37% vs 75%, p < .001). The rate of immunized patients among those eligible was 59.7%. The estimated effectiveness for RSV‐associated lower respiratory tract infection was 81.0% (95% confidence interval: 60.9–90.7), and for preventing severe disease (the need for NIV/CMV), 85.6% (41.7–96.4%). No significant differences by immunization status were observed in patients with RSV concerning viral coinfections, the need for NIV/CMV or length of hospital stay.ConclusionsThis study provides real‐world evidence of the effectiveness of nirsevimab in preventing RSV‐lower respiratory tract infection hospitalization and severe disease in infants during their first RSV season following a systematic immunization program. Immunized patients did not exhibit a higher rate of viral coinfections nor differences in clinical severity once admitted.

show abstract

“…Recent studies have demonstrated efficacy in reducing medically attended RSV infection, with a relative risk reduction of 79.5% (95% CI 65.9 to 87.7) 41–44. Further large-scale studies into use of nirsevimab are ongoing, and as of yet the UK has not released guidance on its use; however, given the reduction in dosing requirements, it is hoped that nirsevimab may prove a more attractive option for wide-scale clinical use than palivizumab 45…”

Section: Introductionmentioning

confidence: 99%

Surveillance towards preventing paediatric incidence of respiratory syncytial virus attributable respiratory tract infection in primary and secondary/tertiary healthcare settings in Merseyside, Cheshire and Bristol, UK

et al. 2023

View full text Add to dashboard Cite

IntroductionRespiratory syncytial virus (RSV) is a common respiratory virus, particularly affecting children, and can cause respiratory infections such as croup and bronchiolitis. The latter is a leading cause of paediatric hospitalisation within the UK. Children <3 years of age and/or with underlying health conditions are more vulnerable to severe RSV infection.There are currently limited data on the incidence of laboratory-confirmed RSV, particularly within primary care settings and outside the typical ‘RSV season’, which in the Northern hemisphere tends to coincide with winter months. There is also a lack of data on the health economic impact of RSV infection on families and healthcare systems.This observational surveillance study aims to collect data on the incidence of laboratory-confirmed RSV-attributable respiratory tract infection (RTI) in children aged <3 years presenting to primary, secondary or tertiary care; it also aims to estimate the health economic and quality of life impact of RSV-attributable infection in this cohort. Such data will contribute to informing public health strategies to prevent RSV-associated infection, including use of preventative medications.Methods and analysisParents/carers of children <3 years of age with RTI symptoms will consent for a respiratory sample (nasal swab) to be taken. Laboratory PCR testing will assess for the presence of RSV and/or other pathogens. Data will be obtained from medical records on demographics, comorbidities, severity of infection and hospitalisation outcomes. Parents will complete questionnaires on the impact of ongoing infection symptoms at day 14 and 28 following enrolment. The primary outcome is incidence of laboratory-confirmed RSV in children <3 years presenting to primary, secondary or tertiary care with RTI symptoms leading to health-seeking behaviours. Recruitment will be carried out from December 2021 to March 2023, encompassing two UK winter seasons and intervening months.Ethics and disseminationEthical approval has been granted (21/WS/0142), and study findings will be published as per International Committee of Medical Journal Editors’ guidelines.

show abstract

RSV: UK to examine whether to offer monoclonal antibody routinely to all babies

Abstract: Nirsevimab has received regulatory approval in the UK, and researchers will now assess its benefits in protecting babies from serious illness from respiratory syncytial virus, as Jacqui Wise reports

Cited by 5 publications

References 5 publications

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants

Nirsevimab immunization's real‐world effectiveness in preventing severe bronchiolitis: A test‐negative case–control study

Surveillance towards preventing paediatric incidence of respiratory syncytial virus attributable respiratory tract infection in primary and secondary/tertiary healthcare settings in Merseyside, Cheshire and Bristol, UK

Contact Info

Product

Resources

About