Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001: results from The Palivizumab Outcomes Registry.

Abstract

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.

• Authors: Curt Parnes, Judith Guillermin, Rolf Habersang, Peggy Nicholes, Vijay Chawla, Tammy Kelly, Judith Fishbein, Patty McRae, Mary Goessler, Antoinette Gatti, John A Calcagno, Cheryl Eki, Kristen A Harris, Joseph Joyave, Kathy McFarland, Paul Protter, Mary Sullivan, Allan Stanford, Nancy Lovett, Marisol Ortiz, Sharon Rojas, Scott Cyrus, Janell Cyrus, Stuart Cohen, Debbie Buchin, Linda Riordan, Monica Zuniga, Rupa Shah, Carmen Minard, Arden Quintin, Glenda Douglas, John van Houten, Sharyn Freutner, Stephen Chartrand, Patsy Nowatzke, Jose Romero, Torunn Rhodes, Michelle Benoit, Emmanuel Walter, Leslie Walker, Laurie DeBonnett, Mia Cross, Teresa Free, Sharman Martin, Karen Shank, Ben Guedes, Lee Ann Atkinson, George J Halpin, Kathy Rouse, Ivan Hand, Donna Geiss, James R Marshall, Lois Burleson, Jim Boland, Kelsey Seybold, Vicki Hunter, Susan Unfer, Jackie Schmucker, Margaret Gley, Michael Marcus, Patricia Thompson, Paulino Milla, Connie Young, Robert Zanni, Virginia Zinno, Alexandra Fetter-Zarzeka, Amanda Busey, Modupe A Sokunbi, Sherrie Airington, Nancy Richard, Vellore Muraligopal, Stephanie Lewis, F Thomas Weber, Beverly P Giordano, Denise Linehan, Jane Roach, Randle Davis, Andrew A Rzepka, Teri Booth, David Smeltzer, Jeanne Walsh, Emilio Arispe, Rhonda Rowley, Christopher Bolling, Tanya Botts, Kateri Haskett, Deana Raby, Evelyn Batiz, Andrew Gelfand, Lynn Farrell, Stephen Butler, Linda Colby, Peter Schochet, Julie Bentler, David Hirsch, Lisa Wilkinson, Allen Aaronson, Eleanora Bennett, Julie Wingate, Dawn Quinn, Katherine Komendowski, Marcia Deckard, Michael Frogel, Cliff Nerwen, Steven Copenhaver, Michele Prater, Jacob Wolsztein, Kristine Mackey, Marshall Benbow, Marisela Naranjo, Sandra Hensley, Cindy Hayes, Hossein Sadeghi, Sally May Lawson, Mark McCall, Karla Combs, Joel Ledbetter, Karen Sarnosky, Cathy Swafford, Michael Speer, Wendy J Barton, J W Mink, Dianne Lemm, Mark Hudak, Elizabeth Case, Judith Rowen, Sandra Fuentes, Carly Pane, Leslie Richardson, Cesar Chavarria, Deanne Cassino, Kourosh Ghaffari, Carol Carroll, Haesoon Lee, Lydia Guclu, Christopher Johnson, Valerie Blum, Marnie L Boron, Mark Sorrentino, Robert L Hirsch, Paul C Van Veldhuisen, Carol Smith, Palivizumab Outcomes Registry Study Group
• Journal: Pediatric pulmonology (Pediatr Pulmonol) Vol. 35 Issue 6 Pg. 484-9 (Jun 2003) ISSN: 8755-6863 [Print] United States
• PMID: 12746948 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2003 Wiley-Liss, Inc.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antiviral Agents
• Palivizumab

Topics

• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antiviral Agents (therapeutic use)
• Female
• Hospitalization
• Humans
• Infant
• Male
• Palivizumab
• Prospective Studies
• Registries
• Respiratory Syncytial Virus Infections (drug therapy, prevention & control)
• Risk Factors
• Treatment Outcome