TY - JOUR
T1 - Evaluation of the safety of palivizumab in the second season of exposure in young children at risk for severe respiratory syncytial virus infection
AU - Lacaze-Masmonteil, Thierry
AU - Seidenberg, Juergen
AU - Mitchell, Ian
AU - Cossey, Veerle
AU - Cihar, Martin
AU - Csader, Michal
AU - Baarsma, Rienk
AU - Valido, Marques
AU - Pollack, Paul F.
AU - Groothuis, Jessie R.
AU - Allegaert, Karel
AU - Lombet, Jacques
AU - Haumont, Dominique
AU - Plaskie, Katleen
AU - Davies, H. Dele
AU - Sauve, Reginald S.
AU - Langley, Joanne M.
AU - Liska, Karel
AU - Andre, Patrick
AU - Lequien, Pierre
AU - Kacet, Nadine
AU - Lapeyre, Fabrice
AU - Wickenburg-Ennen, Barbara
AU - Nolte, Helga
AU - Harding, Peter Andreas
AU - Ramos, Sandra
AU - Carolino, Margarida
AU - Marques, Antónia
N1 - Funding Information:
This study was supported by Abbott Laboratories. We thank Jacky Wu, Ph.D. and Stacy Simpson for their assistance in writing and editing the manuscript, Dr. Randy Tressler for contributions to the protocol design, and Maggie McCue and Michelle Keefe for assistance in preparation of the manuscript.
PY - 2003
Y1 - 2003
N2 - Background: Palivizumab reduces respiratory syncytial virus (RSV) hospitalisations in high-risk infants. Those with severe bronchopulmonary dysplasia may require two seasons of prophylaxis. There is concern that this humanised antibody might cause an adverse immune response in a second season of use. Objective: To evaluate and compare the occurrence of anti-palivizumab antibodies and clinical adverse events in subjects receiving monthly palivizumab injections for a first and second season, and to assess frequency and severity of RSV disease in the two groups. Design and Patients: Subjects aged ≤2 years at severe risk for RSV disease were designated as first season (no previous palivizumab exposure) or second season subjects (received palivizumab in previous RSV season). Palivizumab injections (15 mg/kg) were administered monthly for up to 5 months. Anti-palivizumab antibody titres and serum palivizumab concentrations were measured; adverse events were recorded. Results: No first (n = 71) or second (n = 63) season subjects experienced a significant anti-palivizumab antibody response (titre ≥1:80). Serum palivizumab concentrations were similar for the two groups. Nine (12.7%) first season and 8 (12.7%) second season subjects experienced one or more serious adverse events; most were respiratory and all were considered to be not or probably not related to palivizumab. No deaths occurred during the study. Conclusions: Monthly palivizumab injections were not associated with adverse immune responses or adverse events in young children receiving palivizumab for one or two seasons. Children receiving palivizumab for a second season did not experience more severe adverse events than those receiving it for the first time.
AB - Background: Palivizumab reduces respiratory syncytial virus (RSV) hospitalisations in high-risk infants. Those with severe bronchopulmonary dysplasia may require two seasons of prophylaxis. There is concern that this humanised antibody might cause an adverse immune response in a second season of use. Objective: To evaluate and compare the occurrence of anti-palivizumab antibodies and clinical adverse events in subjects receiving monthly palivizumab injections for a first and second season, and to assess frequency and severity of RSV disease in the two groups. Design and Patients: Subjects aged ≤2 years at severe risk for RSV disease were designated as first season (no previous palivizumab exposure) or second season subjects (received palivizumab in previous RSV season). Palivizumab injections (15 mg/kg) were administered monthly for up to 5 months. Anti-palivizumab antibody titres and serum palivizumab concentrations were measured; adverse events were recorded. Results: No first (n = 71) or second (n = 63) season subjects experienced a significant anti-palivizumab antibody response (titre ≥1:80). Serum palivizumab concentrations were similar for the two groups. Nine (12.7%) first season and 8 (12.7%) second season subjects experienced one or more serious adverse events; most were respiratory and all were considered to be not or probably not related to palivizumab. No deaths occurred during the study. Conclusions: Monthly palivizumab injections were not associated with adverse immune responses or adverse events in young children receiving palivizumab for one or two seasons. Children receiving palivizumab for a second season did not experience more severe adverse events than those receiving it for the first time.
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U2 - 10.2165/00002018-200326040-00005
DO - 10.2165/00002018-200326040-00005
M3 - Article
C2 - 12608889
AN - SCOPUS:0037232387
SN - 0114-5916
VL - 26
SP - 283
EP - 291
JO - Drug Safety
JF - Drug Safety
IS - 4
ER -