Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.
To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.High-risk children prophylaxed against RSV infection were recruited into a prospective, observational, Canadian RSV Evaluation Study of Palivizumab (CARESS) registry with active, ser...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2015-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC4523213?pdf=render |
| _version_ | 1818267971757277184 |
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| author | Jinghan Jenny Chen Parco Chan Bosco Paes Ian Mitchell Abby Li Krista L Lanctôt CARESS investigators |
| author_facet | Jinghan Jenny Chen Parco Chan Bosco Paes Ian Mitchell Abby Li Krista L Lanctôt CARESS investigators |
| author_sort | Jinghan Jenny Chen |
| collection | DOAJ |
| description | To evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.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.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.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. |
| first_indexed | 2024-12-12T20:31:04Z |
| format | Article |
| id | doaj.art-5e5d9c2b2fd245469f828ca454f2bb7b |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-12T20:31:04Z |
| publishDate | 2015-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-5e5d9c2b2fd245469f828ca454f2bb7b2022-12-22T00:13:01ZengPublic Library of Science (PLoS)PLoS ONE1932-62032015-01-01108e013471110.1371/journal.pone.0134711Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention.Jinghan Jenny ChenParco ChanBosco PaesIan MitchellAbby LiKrista L LanctôtCARESS investigatorsTo evaluate the safety and tolerability of palivizumab for RSV prophylaxis in high-risk children in everyday practice.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.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.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.http://europepmc.org/articles/PMC4523213?pdf=render |
| spellingShingle | Jinghan Jenny Chen Parco Chan Bosco Paes Ian Mitchell Abby Li Krista L Lanctôt CARESS investigators Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. PLoS ONE |
| title | Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. |
| title_full | Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. |
| title_fullStr | Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. |
| title_full_unstemmed | Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. |
| title_short | Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. |
| title_sort | serious adverse events in the canadian registry of children receiving palivizumab caress for respiratory syncytial virus prevention |
| url | http://europepmc.org/articles/PMC4523213?pdf=render |
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