Does prophylaxis with palivizumab reduce hospitalisation rates for respiratory‐syncytial‐virus‐related infection in cystic fibrosis children less than 2 years of age?

Elnazir, Basil; Oni, O.O.; Hassan, Taha; Greally, Peter; Paes, Bosco

doi:10.1111/j.1440-1754.2012.02593.x

Cited by 4 publications

(3 citation statements)

References 43 publications

(55 reference statements)

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“…There was no significant difference between palivizumab and placebo groups in terms of RSV hospitalizations. A non‐systematic review of Elnazivir et al does not provide significant data. A review and meta‐analysis, conducted on five observational studies and one RCT, have found that palivizumab prophylaxis in patients with CF during the RSV season might be effective in reducing hospital admission rates.…”

Section: Resultsmentioning

confidence: 97%

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

Pignotti

Leo

Pugi

et al. 2016

Pediatric Pulmonology

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Respiratory syncytial virus infection represents a clinical burden among young children under 24 months. Palivizumab is the only drug licensed in Italy for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus in children at high risk. However recommendations for palivizumab prophylaxis are heterogeneous. Not all the published documents agree about the clinical indications of palivizumab; this could lead to different clinical practices and concerns about the appropriateness of prophylaxis. These issues and the lack of evidence about palivizumab prophylaxis efficacy in specific medical conditions brought on the idea of a consensus conference on the current recommendations for the management and prevention of bronchiolitis, in order to share useful indications. The goal was to perform a review of the evidence regarding the efficacy and the safety of palivizumab and give recommendations in order to harmonize its use. A structured and validated method to conduct the consensus process was adopted. The consensus conference recommends palivizumab prophylaxis in infants born before 29 weeks and younger than 12 months at the start of the epidemic season. According to evidence from literature and experts' opinion, palivizumab prophylaxis is not recommended in preterm infants of gestational age ≥29 weeks, without co-morbidity (i.e., cardiac, bronchopulmonary diseases). The experts identified some clinical rare conditions for which the decision of prophylaxis should be entrusted to the specialists. The evaluation of the appropriateness of palivizumab prophylaxis in the single patient should be documented by the specialists. Pediatr Pulmonol. 2016;51:1088-1096. © 2016 Wiley Periodicals, Inc.

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Section: Resultsmentioning

confidence: 97%

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

Pignotti

Leo

Pugi

et al. 2016

Pediatric Pulmonology

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“…In CF, synergy between virus and bacteria may lead to repetitive bacterial exacerbations [51]. While the majority of pediatric advisory bodies have universally approved RSV prophylaxis for CLD, there remains active debate as to whether CF patients merit palivizumab [43, 45, 52, 53]. The US CF foundation [54, 55] recommends that RSV prophylaxis should be considered for CF patients based on estimated net benefit which was graded as moderate and was derived from the limited number of existing uncontrolled studies.…”

Section: Discussionmentioning

confidence: 99%

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Paes

Mitchell

et al. 2013

Clinical and Developmental Immunology

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Respiratory syncytial virus (RSV) infection occurs commonly in infants aged ≤2 years, and severe infection results in hospitalization with accompanying morbidity and mortality. Palivizumab has been available for prophylaxis for the past 15 years. Prospective data on patients who received palivizumab from 2005 to 2012 has been assembled in the Canadian registry (CARESS) to document utilization, compliance, and health outcomes in both hospital and community settings. Long-term data is necessary to evaluate the impact of palivizumab on the incidence of RSV infections, minimize healthcare resources, and identify which infant subpopulations are receiving prophylaxis. A database search was also conducted for similar information from published registries, and hospitalization rates were compared to results from randomized clinical trials (RCTs).Overall hospitalization rates (percent; range) for respiratory-related illnesses and RSV-specific infection in infants who meet standard indications for prophylaxis were 6.6 (3.3–7.7) and 1.55 (0.3–2.06), respectively, in CARESS, which closely aligns with registry data from 4 other countries, despite the former comprising the largest cohort of complex patients internationally. Overall RSV-related hospitalization rates were lower across registries compared to equivalent patients in RCTs. Registry data provides valuable information regarding real-world experience with palivizumab, while facilitating the genesis of new research themes.

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“…Two recent reviews 20,66 of RSV infection in infants with cystic fibrosis acknowledged that infants with cystic fibrosis may have a slightly increased risk for hospitalization with RSV. However, they both stated that there is insufficient evidence related to safety and efficacy in infants with cystic fibrosis to support a recommendation of palivizumab prophylaxis.…”

Section: Children With Cystic Fibrosismentioning

confidence: 99%

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

Brady¹,

Byington²,

Davies³

et al. 2014

Pediatrics

311

170

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Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy statement in 1998. Guidance initially was based on the result from a single randomized, placebo-controlled clinical trial conducted in 1996–1997 describing an overall reduction in RSV hospitalization rate from 10.6% among placebo recipients to 4.8% among children who received prophylaxis. The results of a second randomized, placebo-controlled trial of children with hemodynamically significant heart disease were published in 2003 and revealed a reduction in RSV hospitalization rate from 9.7% in control subjects to 5.3% among prophylaxis recipients. Because no additional controlled trials regarding efficacy were published, AAP guidance has been updated periodically to reflect the most recent literature regarding children at greatest risk of severe disease. Since the last update in 2012, new data have become available regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effects of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, and the effect of prophylaxis on wheezing and palivizumab-resistant RSV isolates. These data enable further refinement of AAP guidance to most clearly focus on those children at greatest risk.

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Does prophylaxis with palivizumab reduce hospitalisation rates for respiratory‐syncytial‐virus‐related infection in cystic fibrosis children less than 2 years of age?

Cited by 4 publications

References 43 publications

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

Respiratory-Related Hospitalizations following Prophylaxis in the Canadian Registry for Palivizumab (2005–2012) Compared to Other International Registries

Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

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