Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention

Jinghan Jenny Chen, Parco Chan, Bosco Paes, Ian Mitchell, Abby Li, Krista L Lanctôt, CARESS investigators, Candice Bjornson, Ian Mitchell, Mark Chilvers, Georges Caouette, Marc Lebel, Mario Eddy Dumas, Charles Hui, Ann Bayliss, Bruno DiGravio, Jean-Pierre Doray, Dora Stinson, Apostolos Papageorgiou, Marianna Mitchell, David Lee, April Price, Aaron Chiu, Bosco Paes, Roderick Canning, Anne-Marie Canakis, Jesse Papenburg, Karel O'Brien, Karen Chang, Koravangattu Sankaran, Vincent Ho, Larry Chang, Cecil Ojah, Sanja Avdic, Upton Allen, Carina Majaesic, Marc Blayney, Brian Simmons, Kiang Tang, Jelena Popovic, Frank Jagdis, Ivor Margolis, Godfrey Bacheyie, Jinghan Jenny Chen, Parco Chan, Bosco Paes, Ian Mitchell, Abby Li, Krista L Lanctôt, CARESS investigators, Candice Bjornson, Ian Mitchell, Mark Chilvers, Georges Caouette, Marc Lebel, Mario Eddy Dumas, Charles Hui, Ann Bayliss, Bruno DiGravio, Jean-Pierre Doray, Dora Stinson, Apostolos Papageorgiou, Marianna Mitchell, David Lee, April Price, Aaron Chiu, Bosco Paes, Roderick Canning, Anne-Marie Canakis, Jesse Papenburg, Karel O'Brien, Karen Chang, Koravangattu Sankaran, Vincent Ho, Larry Chang, Cecil Ojah, Sanja Avdic, Upton Allen, Carina Majaesic, Marc Blayney, Brian Simmons, Kiang Tang, Jelena Popovic, Frank Jagdis, Ivor Margolis, Godfrey Bacheyie

Abstract

Objectives: To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.

Methods: High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, serious adverse event (SAE) monitoring from 2008 to 2013. SAE reports were systematically collected and assessed for severity and relationship to palivizumab. Data were analyzed by Chi-square or Fisher Exact Tests to examine group differences in proportions.

Results: 13025 infants received 57392 injections. Hospitalizations for respiratory-related illness (RIH) were reported in 915 patients, and SAEs other than RIH were reported in 52 patients. Of these, 6 (0.05%) patients had a total of 14 hypersensitivity reactions that were deemed possibly or probably related to palivizumab (incidence: 2.8 per 10,000 patient-months). The SAEs of 42 patients were assessed as not related to palivizumab. SAEs in the remaining 4 patients were not classifiable as their records were incomplete. There were no significant demographic predictors of SAE occurrence.

Conclusions: Under active surveillance, a small proportion of infants in the CARESS registry experienced SAEs that had a potential relationship with palivizumab and these appeared to be unpredictable in terms of onset. Palivizumab appears to be a safe and well-tolerated antibody for RSV prophylaxis in high-risk children in routine practice.

Conflict of interest statement

Competing Interests: Bosco Paes, Ian Mitchell and Krista Lanctôt have received research funding from AbbVie Corporation and compensation as advisors or lecturers from AbbVie Corporation and MedImmune. Abby Li has received speaker’s fees from AbbVie Canada. Jinghan Chen and Parco Chan have no conflicts of interest to declare. This, too, does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow diagram of the assessment…
Fig 1. Flow diagram of the assessment of adverse events.
Fig 2. Flow diagram of recruited subjects…
Fig 2. Flow diagram of recruited subjects and related serious adverse events.
*Note: The premature group refers to preterm infants only; the “Other” category of infants with serious underlying medical disorders also comprises premature infants.

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