PMID- 28895096
OWN - NLM
STAT- MEDLINE
DCOM- 20180424
LR  - 20240323
IS  - 1179-2019 (Electronic)
IS  - 1174-5878 (Print)
IS  - 1174-5878 (Linking)
VI  - 20
IP  - 1
DP  - 2018 Feb
TI  - Palivizumab Prophylaxis Against Respiratory Syncytial Virus Infection in Children 
      with Immunocompromised Conditions or Down Syndrome: A Multicenter, Post-Marketing 
      Surveillance in Japan.
PG  - 97-104
LID - 10.1007/s40272-017-0264-y [doi]
AB  - OBJECTIVE: The aim of this study was to assess the safety and effectiveness of 
      palivizumab for the prevention of lower respiratory tract infection (LRI) caused 
      by respiratory syncytial virus (RSV) in children with immunocompromised 
      conditions or Down syndrome. METHODS: In this multicenter, post-marketing 
      surveillance study (December 2013 to December 2015), children aged </=24 months 
      with immunocompromised conditions or Down syndrome (without hemodynamically 
      significant congenital heart disease) receiving palivizumab immunoprophylaxis 
      during two RSV seasons were observed until 30 days after the final palivizumab 
      injection. Safety [adverse events (AEs), serious AEs (SAEs), adverse drug 
      reactions (ADRs), serious ADRs (SADRs)] and effectiveness (frequency, incidence, 
      and duration of hospitalization due to RSV infections) were assessed. RESULTS: Of 
      304 patients receiving palivizumab, 167 (54.9%) had immunocompromised conditions, 
      and 138 (45.4%) had Down syndrome; 260 (85.5%) completed palivizumab 
      immunoprophylaxis. The annual mean (+/-standard deviation) number of doses was 5.3 
      (+/-2.4) per season. Overall, 220 AEs occurred in 99 patients (32.6%), including 89 
      SAEs in 53 patients (17.4%). Of these, 33 AEs in 25 patients (8.22%) were 
      considered ADRs, and 13 ADRs in 11 patients (3.62%) were considered SADRs. In 
      four patients, five SADRs (nephroblastoma and asthma in the same patient, septic 
      shock, device-related infection, and drug-induced liver injury) were previously 
      unreported; however, none were considered drug-related. During the observation 
      period, five RSV infections occurred and two patients required hospitalization. 
      CONCLUSION: Palivizumab was generally safe and effective for the prevention of 
      LRI caused by RSV in newborns, infants, and children with immunocompromised 
      conditions or Down syndrome up to the age of 24 months.
FAU - Kashiwagi, Tomoko
AU  - Kashiwagi T
AD  - AbbVie GK, Mita 3-5-27, Minato-ku, Tokyo, 108-6302, Japan.
FAU - Okada, Yukiko
AU  - Okada Y
AD  - AbbVie GK, Mita 3-5-27, Minato-ku, Tokyo, 108-6302, Japan.
FAU - Nomoto, Ken
AU  - Nomoto K
AD  - AbbVie GK, Mita 3-5-27, Minato-ku, Tokyo, 108-6302, Japan. ken.nomoto@abbvie.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - Switzerland
TA  - Paediatr Drugs
JT  - Paediatric drugs
JID - 100883685
RN  - DQ448MW7KS (Palivizumab)
SB  - IM
EIN - Paediatr Drugs. 2018 Apr 10;:. PMID: 29637469
MH  - Child, Preschool
MH  - Down Syndrome/*complications
MH  - Humans
MH  - Immunocompromised Host/*drug effects
MH  - Japan
MH  - Palivizumab/administration & dosage/pharmacology/*therapeutic use
MH  - Prospective Studies
MH  - Respiratory Syncytial Virus Infections/*drug therapy/*prevention & control
PMC - PMC5775975
COIS- FUNDING: This study was supported for funding and data collection by AbbVie GK, 
      Tokyo, Japan. CONFLICT OF INTEREST: All authors are full-time employees of AbbVie 
      GK. ETHICAL APPROVAL: This study conformed to the Good Post-marketing Study 
      Practice (GPSP; MHLW ordinance). The study protocol was reviewed and approved in 
      advance by the Pharmaceuticals and Medical Devices Agency, Japan. For this 
      reason, no ethical review by the individual facilities participating in the study 
      was conducted. Because informed consent is not required for post-marketing 
      observational studies that are conducted under the GPSP in Japan, the present 
      study did not solicit informed consent from the patients.
EDAT- 2017/09/13 06:00
MHDA- 2018/04/25 06:00
PMCR- 2017/09/11
CRDT- 2017/09/13 06:00
PHST- 2017/09/13 06:00 [pubmed]
PHST- 2018/04/25 06:00 [medline]
PHST- 2017/09/13 06:00 [entrez]
PHST- 2017/09/11 00:00 [pmc-release]
AID - 10.1007/s40272-017-0264-y [pii]
AID - 264 [pii]
AID - 10.1007/s40272-017-0264-y [doi]
PST - ppublish
SO  - Paediatr Drugs. 2018 Feb;20(1):97-104. doi: 10.1007/s40272-017-0264-y.