PALIVIZUMAB, A HUMANIZED RESPIRATORY SYNCYTIAL VIRUS MONOCLONAL-ANTIBODY, REDUCES HOSPITALIZATION FROM RESPIRATORY SYNCYTIAL VIRUS-INFECTION IN HIGH-RISK INFANTS

Authors
NULL D BIMLE C WEISMAN L JOHNSON K STEICHEN J SINGH S WANG E ASZTALOS E LOEFFLER AM AZIMI PH LIEBERMAN JM ODONNELL NE COOKE RJ MCCORMICK K KOO W HAMMAMI M MILNER AD GAON P NACHMAN S TARPEY KP SANCHEZ PJ BROYLES RS BRATCHER D BALL MV DUDA FJ DECUIR PM POLLARA B NELSON LS BALBUS M SCHULTZ MJ CHIPPS BE GIVNER LB OSHEA M EVERARD M PFEFFER K PAGE AJ DENNEHY PH MODLIN J RHODES T DEVINCENZO N NICKERSON B ARRIETA A BOUCHER FD KEENEY RE YOUNG TE STEVENS JC ARIAGNO R ADAMS M POLAK MJ LYNCH SK GERDES JS KUBA M AOUTHMANY M LAMAR K CHANG GYW SHELTON MM HADEED SKW VASAN U HENNESSY A YOGEV R WELLIVER RC TRISTRAM D ALBIN C JEFFERSON TT PURDY GD BUCKNER CM SCHLESSEL J SIA C TAN B SANKARAN K MORLEY CJ WHITE DK MEISSNER HC FRANTZ I DESAI SA STANLEY CW INWOOD R SOLECKI LE WALD E SMAIL K FOX RE TACIAK V PARK CL VIDYASAGAR D REDDING G MAYOCK DE REUMAN PD BIFANO EM ESTRADA B MANCAO MY HOOK B MCDAVID G ROWEN JL PATEL JA ROBINSON J LEE B RODRIGUEZ W ARROBIO J HOCKER JR MCCONNELL C PIEDIMONTE G SOSENKO I PATEL B SHERVINSKI S STOBIE PE PEREA K CHARTRAND SA WILSON MC DELEMOS R RAMANATHAN R BARNETT BA LUBER SR RASZKA WV HOLSCLAW DS KLEIN DL LAW BJ BALSAN MJ DOUGLASS BH OSULLIVAN BP SPAULDING R VANDYKE RB MERZA A HENDLEY JO BOYLE RJ HUGHES PA HORGAN MJ MAYNARD RC TEUFERT K MAJURE M GEORGE JA KUERSCHNER DR GHAI V THOMAS D MACDONALD N KOVESI T BLAYNEY M MANI CS SANJOAQUIN VH ROBERTS L WIZNIA A ROSENBERG M KARNA P MURRAY DL LENNEY W CLAYTON S OELBERG DG REININGER MM EPPES SC CHILDS JA GRUBER WC HAZINSKI TR STEINBERG EA LOPEZ LC ELLIOTT GR GROOTHUIS JR SIMOES EEAF HAKIM A MIMOUNI F RUBIN L SOOD SK SADIQ HF MARSHALL TG MILLER D DRAYTON MR ONEILL S CHETCUTI P TRUPP DL HEART J COOPER ER BROWN ER CHETTY A RICE TB RUPAR D CHO CT LEFF RD LEVINE SD KOLLS JK HALL M SMITH SL SCHWARTZ L LEMEN RJ HALL CB LONG CE PANITCH H KOLB SM COLOMBO JL JUDY CG GOLEMBE BL ANDERSON JD MCDONALD J MCCORMACK D RUGGERIE DP TRIPLETT C ODOM MW LOPEZCOX G SAWYER MH CONNOR JD FERGIE JE PURCELL K KANTAK AD FIHE DM DAVIES HD MITCHELL L SUBRAMANIAN KNS SMITH Y STJOHN EB STOLZ JW SHEILS C COX F FOSHEE W DIAZ R COONCE S KEYSERLING HL PADRICK CB LAMPRECHT C LIVINGSTON FR LANGLEY JM WELLER P CROPP GJ SOLA A KUMAR ML LAPIN CD CARLISLE P MARTZ R RADETSKY M MIDANI S RATHORE MH RIFF EJ SHAY GF HOGVALL E RUSSELL DW THOMSON AH LAWREY SM HARDY K HARVEY K TURNER R COX EO DANA A MADAN A WALLACE J STEVENS DC ASMAR B SELEWSKI NA KELLY J KLERR T SPRUILL S CONNER EM CARLIN D TOP FH
Citation
D. Null et al., PALIVIZUMAB, A HUMANIZED RESPIRATORY SYNCYTIAL VIRUS MONOCLONAL-ANTIBODY, REDUCES HOSPITALIZATION FROM RESPIRATORY SYNCYTIAL VIRUS-INFECTION IN HIGH-RISK INFANTS, Pediatrics (Evanston), 102(3), 1998, pp. 531-537
Citations number
12
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pediatrics
Journal title
ISSN journal
0031-4005
Volume
102
Issue
3
Year of publication
1998
Pages
531 - 537
Database
ISI
SICI code
0031-4005(1998)102:3<531:PAHRSV>2.0.ZU;2-T
Abstract
Objective. To determine the safety and efficacy of prophylaxis with pa livizumab in reducing the incidence of hospitalization because of resp iratory syncytial virus (RSV) infection in high-risk infants. Methods. A randomized, double-blind, placebo-controlled trial was conducted at 139 centers in the United States, the United Kingdom, and Canada. Dur ing the 1996 to 1997 RSV season, 1502 children with prematurity (less than or equal to 35 weeks) or bronchopulmonary dysplasia (BPD) were ra ndomized to receive 5 injections of either palivizumab (15 mg/kg) or a n equivalent volume of placebo by intramuscular injection every 30 day s. The primary endpoint was hospitalization with confirmed RSV infecti on. Children were followed for 150 days (30 days from the last injecti on). Those with hospitalization as a result of RSV infection were eval uated for total number of days in the hospital, total days with increa sed supplemental oxygen, total days with moderate or severe lower resp iratory tract illness, and incidence and total days of intensive care and mechanical ventilation. The incidence of hospitalization for respi ratory illness not caused by RSV and the incidence of otitis media wer e also evaluated. The placebo and palivizumab groups were balanced at entry for demographics and RSV risk factors. Ninety-nine percent of ch ildren in both groups completed the protocol and similar to 93% receiv ed all five scheduled injections. Results. Palivizumab prophylaxis res ulted in a 55% reduction in hospitalization as a result of RSV (10.6% placebo vs 4.8% palivizumab). Children with prematurity but without BP D had a 78% reduction in RSV hospitalization (8.1% vs 1.8%); children with BPD had a 39% reduction (12.8% vs 7.9%). When gender, entry age, entry weight, BPD, and gestational age were included in a logistic reg ression model, the effect of prophylaxis with palivizumab remained sta tistically significant. The palivizumab group had proportionally fewer total RSV hospital days, fewer RSV hospital days with increased oxyge n, fewer RSV hospital days with a moderate/severe lower respiratory tr act illness, and a lower incidence of intensive care unit admission. P alivizumab was safe and well tolerated. No significant differences wer e observed in reported adverse events between the two groups. Few chil dren discontinued injections for related adverse events (0.3%). Reacti ons at the site of injection were uncommon (1.8% placebo vs 2.7% paliv izumab); the most frequent reaction was mild and transient erythema. M ild or moderate elevations of aspartate aminotransferase occurred in 1 .6% of placebo recipients and 3.6% of palivizumab recipients; for alan ine aminotransferase these percentages were 2.0% and 2.3%, respectivel y. Hepatic and renal adverse events related to the study drug were sim ilar in the two groups. Conclusions. Monthly intramuscular administrat ion of palivizumab is safe and effective for prevention of serious RSV illness in premature children and those with BFD.