Effectiveness of Palivizumab against Respiratory Syncytial Virus

Cohort and Case Series Analysis

Hannah C. Moore, Nicholas de Klerk, Peter C. Richmond, Parveen Fathima, Ruomei Xu, Anthony D. Keil, Thomas L. Snelling, Tobias Strunk

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Objective: To measure the real-world effectiveness of palivizumab immunoprophylaxis against respiratory syncytial virus (RSV)-confirmed infection before age 2 years in a population-cohort of high-risk infants.

    Study design: Palivizumab is funded for high-risk infants in Western Australia. We used probabilistically linked administrative data encompassing RSV laboratory-confirmed infections, hospital admissions, and palivizumab dispensing records for a cohort of 24 329 high-risk infants admitted to neonatal intensive care units, born 2002-2013 with follow-up to 2015. We used a traditional cohort method with Cox proportional hazards regression and a self-controlled case series analysis to assess effectiveness of palivizumab in reducing RSV-confirmed infection by number of doses.

    Results: From the cohort of 24 329 infants, 271 (1.1%) received at least 1 dose of palivizumab and 1506 (6.2%) had at least 1 RSV-confirmed infection before age 2 years. Using the traditional cohort approach, we found no protective association of palivizumab receipt with RSV detection (adjusted hazard ratio = 0.99 [95% CI 0.5, 1.9] for 1 dose). However, using a self-controlled case series to eliminate confounding by indication, a protective association was seen with a 74% lower RSV incidence (relative incidence = 0.26; 95% CI 0.11, 0.67) following any dose of palivizumab compared with control (nonexposed) periods.

    Conclusions: After accounting for confounding by indication through a self-controlled analysis, palivizumab appeared effective for reducing virologically confirmed RSV in this high-risk cohort.

    Original languageEnglish
    Pages (from-to)1-8
    Number of pages8
    JournalJournal of Pediatrics
    Volume214
    Issue numberNovember
    Early online date1 Aug 2019
    DOIs
    Publication statusPublished - Nov 2019

    Fingerprint

    Respiratory Syncytial Viruses
    Respiratory Syncytial Virus Infections
    Laboratory Infection
    Western Australia
    Palivizumab
    Neonatal Intensive Care Units
    Incidence

    Cite this

    Moore, H. C., de Klerk, N., Richmond, P. C., Fathima, P., Xu, R., Keil, A. D., ... Strunk, T. (2019). Effectiveness of Palivizumab against Respiratory Syncytial Virus: Cohort and Case Series Analysis. Journal of Pediatrics, 214(November), 1-8. https://doi.org/10.1016/j.jpeds.2019.06.058
    Moore, Hannah C. ; de Klerk, Nicholas ; Richmond, Peter C. ; Fathima, Parveen ; Xu, Ruomei ; Keil, Anthony D. ; Snelling, Thomas L. ; Strunk, Tobias. / Effectiveness of Palivizumab against Respiratory Syncytial Virus : Cohort and Case Series Analysis. In: Journal of Pediatrics. 2019 ; Vol. 214, No. November. pp. 1-8.
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    abstract = "Objective: To measure the real-world effectiveness of palivizumab immunoprophylaxis against respiratory syncytial virus (RSV)-confirmed infection before age 2 years in a population-cohort of high-risk infants. Study design: Palivizumab is funded for high-risk infants in Western Australia. We used probabilistically linked administrative data encompassing RSV laboratory-confirmed infections, hospital admissions, and palivizumab dispensing records for a cohort of 24 329 high-risk infants admitted to neonatal intensive care units, born 2002-2013 with follow-up to 2015. We used a traditional cohort method with Cox proportional hazards regression and a self-controlled case series analysis to assess effectiveness of palivizumab in reducing RSV-confirmed infection by number of doses. Results: From the cohort of 24 329 infants, 271 (1.1{\%}) received at least 1 dose of palivizumab and 1506 (6.2{\%}) had at least 1 RSV-confirmed infection before age 2 years. Using the traditional cohort approach, we found no protective association of palivizumab receipt with RSV detection (adjusted hazard ratio = 0.99 [95{\%} CI 0.5, 1.9] for 1 dose). However, using a self-controlled case series to eliminate confounding by indication, a protective association was seen with a 74{\%} lower RSV incidence (relative incidence = 0.26; 95{\%} CI 0.11, 0.67) following any dose of palivizumab compared with control (nonexposed) periods. Conclusions: After accounting for confounding by indication through a self-controlled analysis, palivizumab appeared effective for reducing virologically confirmed RSV in this high-risk cohort.",
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    Moore, HC, de Klerk, N, Richmond, PC, Fathima, P, Xu, R, Keil, AD, Snelling, TL & Strunk, T 2019, 'Effectiveness of Palivizumab against Respiratory Syncytial Virus: Cohort and Case Series Analysis', Journal of Pediatrics, vol. 214, no. November, pp. 1-8. https://doi.org/10.1016/j.jpeds.2019.06.058

    Effectiveness of Palivizumab against Respiratory Syncytial Virus : Cohort and Case Series Analysis. / Moore, Hannah C.; de Klerk, Nicholas; Richmond, Peter C.; Fathima, Parveen; Xu, Ruomei; Keil, Anthony D.; Snelling, Thomas L.; Strunk, Tobias.

    In: Journal of Pediatrics, Vol. 214, No. November, 11.2019, p. 1-8.

    Research output: Contribution to journalArticleResearchpeer-review

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    T1 - Effectiveness of Palivizumab against Respiratory Syncytial Virus

    T2 - Cohort and Case Series Analysis

    AU - Moore, Hannah C.

    AU - de Klerk, Nicholas

    AU - Richmond, Peter C.

    AU - Fathima, Parveen

    AU - Xu, Ruomei

    AU - Keil, Anthony D.

    AU - Snelling, Thomas L.

    AU - Strunk, Tobias

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    N2 - Objective: To measure the real-world effectiveness of palivizumab immunoprophylaxis against respiratory syncytial virus (RSV)-confirmed infection before age 2 years in a population-cohort of high-risk infants. Study design: Palivizumab is funded for high-risk infants in Western Australia. We used probabilistically linked administrative data encompassing RSV laboratory-confirmed infections, hospital admissions, and palivizumab dispensing records for a cohort of 24 329 high-risk infants admitted to neonatal intensive care units, born 2002-2013 with follow-up to 2015. We used a traditional cohort method with Cox proportional hazards regression and a self-controlled case series analysis to assess effectiveness of palivizumab in reducing RSV-confirmed infection by number of doses. Results: From the cohort of 24 329 infants, 271 (1.1%) received at least 1 dose of palivizumab and 1506 (6.2%) had at least 1 RSV-confirmed infection before age 2 years. Using the traditional cohort approach, we found no protective association of palivizumab receipt with RSV detection (adjusted hazard ratio = 0.99 [95% CI 0.5, 1.9] for 1 dose). However, using a self-controlled case series to eliminate confounding by indication, a protective association was seen with a 74% lower RSV incidence (relative incidence = 0.26; 95% CI 0.11, 0.67) following any dose of palivizumab compared with control (nonexposed) periods. Conclusions: After accounting for confounding by indication through a self-controlled analysis, palivizumab appeared effective for reducing virologically confirmed RSV in this high-risk cohort.

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    KW - self-controlled case series

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