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Adherence and outcomes: a systematic review of palivizumab utilization
Sophie K Wong1, Abby Li1, Krista L Lanctôt1
1a Medical Outcomes and Research in Economics (MORE®) Research Group, Sunnybrook Health Sciences Centre, University of Toronto , Toronto , ON , Canada.
Insights
Consistent adherence to monthly palivizumab dosing is crucial for respiratory syncytial virus (RSV) prophylaxis in young children. This review highlights the need for standardized definitions of adherence to improve evidence on palivizumab effectiveness.
Area of Science:
- Pediatric Infectious Diseases
- Immunology
- Pharmacology
Background:
- Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections in children under two years old.
- Palivizumab, a monoclonal antibody, is used for RSV prophylaxis, requiring strict monthly dosing for efficacy.
- Inconsistent adherence can reduce palivizumab's effectiveness and increase the risk of RSV infection and hospitalization.
Purpose of the Study:
- To review the variability in defining and reporting adherence to palivizumab prophylaxis across studies.
- To assess the relationship between adherence to monthly dosing protocols and reported outcomes in published trials.
Main Methods:
- Literature review of studies on palivizumab efficacy and safety.
- Analysis of adherence definitions and reporting in randomized controlled trials.
- Assessment of outcome data in relation to adherence to monthly dosing schedules.
Main Results:
- Significant variability exists in the definition and reporting of palivizumab adherence.
- A clear relationship between adherence and outcomes needs further investigation due to inconsistent reporting.
- Lack of standardized adherence metrics complicates the interpretation of palivizumab effectiveness.
Conclusions:
- Standardized, detailed reporting of palivizumab adherence is essential for robust evidence.
- Consistent definitions will aid in understanding effectiveness variations and informing guidelines.
- Improved adherence data can impact cost-effectiveness analyses and clinical recommendations.
Introduction:
Palivizumab is a humanized monoclonal antibody used for respiratory syncytial virus (RSV) prophylaxis. RSV is the primary cause of lower respiratory tract infection in children aged <2 years, and can give rise to high-burden hospitalization and respiratory complications in later life. Adherence to a monthly dosing regimen, both in timing and injection number, is essential to sustain therapeutic levels of palivizumab and maintain protective status. Deviation from the approved dosing schedule may reduce the efficacy of palivizumab and increase the risk of breakthrough RSV infection and hospitalization. Areas covered: There is no standardized definition of adherence to palivizumab treatment. This review addresses the wide variability in defining and reporting adherence to palivizumab prophylaxis across different studies. The review assesses whether a relationship exists in the outcomes reported in studies relative to the monthly adherence protocol as defined in published randomized controlled trials of the efficacy and safety of palivizumab. Expert commentary: Standardized detailed reporting of adherence to palivizumab prophylaxis using consistent definitions will help provide a more robust level of evidence. This information may be important when considering variations in effectiveness, alterations to recommendations and guidelines, and cost-effectiveness of treatment.
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