Adherence and outcomes: a systematic review of palivizumab utilization

Abstract

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.

Detection of ON1 and novel genotypes of human respiratory syncytial virus and emergence of palivizumab resistance in Lebanon

“…Clinical isolates with N262D, K272E/M/Q and S275F/L substitutions in the palivizumab-binding site (antigenic site II, amino acids 258–275) exhibited resistance to neutralization by palivizumab [17]. These mutations were linked to breakthrough infections upon prophylactic treatment [46]. Here, we also report that all RSV-A strains circulating in Lebanon carry an N276S mutation that confer partial resistance to palivizumab and constitute a serious concern for the prevention of RSV infections in at-risk population [31, 32].…”

Effectiveness of palivizumab in preventing respiratory syncytial virus infection in high-risk children

“… 30 Some authors have shown that home administration of palivizumab may generate better results as it increases compliance and reduces environmental exposures within the hospital of high-risk children. 31 This may be improved by detecting the factors associated with poor adherence, 32 and educational interventions. 33 Nirsevimab, a new monoclonal antibody with an extended half-life for RSV prophylaxis in healthy preterm infants, is being developed to protect infants for an entire RSV season with a single intramuscular dose.…”

Innate Inspiration: Antifungal Peptides and Other Immunotherapeutics From the Host Immune Response

“…Most therapeutic monoclonal antibodies are used for the treatment of cancer or immunological disorders ( 397 , 398 ). The development of monoclonal antibodies for the prevention and treatment of infectious diseases lags somewhat behind their development for other therapeutic areas, e.g., cancer and autoimmune diseases ( 399 ), and only three monoclonal antibodies have received approval for infectious disease prophylaxis or treatment; palivizumab for prevention of respiratory syncytial virus in high-risk infants ( 400 ); and obiltoxaximab ( 401 ) and raxibacumab ( 402 ) for prophylaxis and treatment of anthrax. The lack of development of mAb for infectious diseases may be because consensus on clinical end-points and definitions on conditions of use are lacking, as well as high costs associated with their development and lack of a cle arly defined market for these products ( 399 ).…”