Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001: results from The Palivizumab Outcomes Registry.
The objective of the Registry was to characterize the population of infants receiving prophylaxis for respiratory syncytial virus (RSV) disease by describing the patterns and scope of usage of palivizumab in a cross section of US infants. RSV hospitalization outcomes were also described. The Palivizumab (Synagis, MedImmune, Inc., 25 West Watkins Mill Road, Gaithersburg, MD 20878) Outcomes Registry was a prospective multicenter survey conducted at 63 sites. Demographics, injection history, and RSV hospitalization outcomes were collected on 2,116 infants receiving palivizumab. Infants were enrolled in the Registry between September 1, 2000-March 1, 2001, at the time of their first injection. Infants born at less than 32 weeks of gestation accounted for 47% of infants enrolled, and those between 32-35 weeks accounted for 45%; approximately 8% were greater than 35 weeks of gestation. Lower RSV hospitalization rates were observed in infants who had greater adherence to regularly scheduled injections. Nearly one-half of all hospitalizations occurred within the first and second injection intervals, suggesting the importance of early RSV protection. The confirmed RSV hospitalization rate of all infants in the Registry was 2.9%; the rate was 5.8% in infants with chronic lung disease of infancy, and 2.1% in premature infants without chronic lung disease. In conclusion, these data support the continued effectiveness of palivizumab prophylaxis for severe RSV lower respiratory tract disease in a large cohort of high-risk infants from geographically diverse pediatric offices and clinics. The Palivizumab Outcomes Registry provides an opportunity to assess palivizumab utilization and clinical effectiveness in the US.
Curt
C
Parnes
Judith
J
Guillermin
Rolf
R
Habersang
Peggy
P
Nicholes
Vijay
V
Chawla
Tammy
T
Kelly
Judith
J
Fishbein
Patty
P
McRae
Mary
M
Goessler
Antoinette
A
Gatti
John A
JA
Calcagno
Cheryl
C
Eki
Kristen A
KA
Harris
Joseph
J
Joyave
Kathy
K
McFarland
Paul
P
Protter
Mary
M
Sullivan
Allan
A
Stanford
Nancy
N
Lovett
Marisol
M
Ortiz
Sharon
S
Rojas
Scott
S
Cyrus
Janell
J
Cyrus
Stuart
S
Cohen
Debbie
D
Buchin
Linda
L
Riordan
Monica
M
Zuniga
Rupa
R
Shah
Carmen
C
Minard
Arden
A
Quintin
Glenda
G
Douglas
John
J
van Houten
Sharyn
S
Freutner
Stephen
S
Chartrand
Patsy
P
Nowatzke
Jose
J
Romero
Torunn
T
Rhodes
Michelle
M
Benoit
Emmanuel
E
Walter
Leslie
L
Walker
Laurie
L
DeBonnett
Mia
M
Cross
Teresa
T
Free
Sharman
S
Martin
Karen
K
Shank
Ben
B
Guedes
Lee Ann
LA
Atkinson
George J
GJ
Halpin
Kathy
K
Rouse
Ivan
I
Hand
Donna
D
Geiss
James R
JR
Marshall
Lois
L
Burleson
Jim
J
Boland
Kelsey
K
Seybold
Vicki
V
Hunter
Susan
S
Unfer
Jackie
J
Schmucker
Margaret
M
Gley
Michael
M
Marcus
Patricia
P
Thompson
Paulino
P
Milla
Connie
C
Young
Robert
R
Zanni
Virginia
V
Zinno
Alexandra
A
Fetter-Zarzeka
Amanda
A
Busey
Modupe A
MA
Sokunbi
Sherrie
S
Airington
Nancy
N
Richard
Vellore
V
Muraligopal
Stephanie
S
Lewis
F Thomas
FT
Weber
Beverly P
BP
Giordano
Denise
D
Linehan
Jane
J
Roach
Randle
R
Davis
Andrew A
AA
Rzepka
Teri
T
Booth
David
D
Smeltzer
Jeanne
J
Walsh
Emilio
E
Arispe
Rhonda
R
Rowley
Christopher
C
Bolling
Tanya
T
Botts
Kateri
K
Haskett
Deana
D
Raby
Evelyn
E
Batiz
Andrew
A
Gelfand
Lynn
L
Farrell
Stephen
S
Butler
Linda
L
Colby
Peter
P
Schochet
Julie
J
Bentler
David
D
Hirsch
Lisa
L
Wilkinson
Allen
A
Aaronson
Eleanora
E
Bennett
Julie
J
Wingate
Dawn
D
Quinn
Katherine
K
Komendowski
Marcia
M
Deckard
Michael
M
Frogel
Cliff
C
Nerwen
Steven
S
Copenhaver
Michele
M
Prater
Jacob
J
Wolsztein
Kristine
K
Mackey
Marshall
M
Benbow
Marisela
M
Naranjo
Sandra
S
Hensley
Cindy
C
Hayes
Hossein
H
Sadeghi
Sally May
SM
Lawson
Mark
M
McCall
Karla
K
Combs
Joel
J
Ledbetter
Karen
K
Sarnosky
Cathy
C
Swafford
Michael
M
Speer
Wendy J
WJ
Barton
J W
JW
Mink
Dianne
D
Lemm
Mark
M
Hudak
Elizabeth
E
Case
Judith
J
Rowen
Sandra
S
Fuentes
Carly
C
Pane
Leslie
L
Richardson
Cesar
C
Chavarria
Deanne
D
Cassino
Kourosh
K
Ghaffari
Carol
C
Carroll
Haesoon
H
Lee
Lydia
L
Guclu
Christopher
C
Johnson
Valerie
V
Blum
Marnie L
ML
Boron
Mark
M
Sorrentino
Robert L
RL
Hirsch
Paul C
PC
Van Veldhuisen
Carol
C
Smith
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D000069455:Palivizumab; D011446:Prospective Studies; D012042:Registries; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy / Q000517:prevention & control*; D012307:Risk Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D000069455:Palivizumab