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PEDIATRICS Vol. 103 No. 2 February 1999, pp. 495-496

COMMENTARY:
Comments on Palivizumab (Synagis)

The first 20% of the full text of this article appears below.

Caregivers and third-party payors need additional information from the Impact study1 investigators to determine the appropriate use of palivizumab (Synagis) in select premature infants with increased risk of respiratory syncytial virus (RSV)-associated hospitalization. The primary outcome variable of hospitalization within 30 days of the last dose of palivizumab may have missed patients who actually became ill with RSV later in the epidemic under study. Could the investigators provide data on the incidence of RSV hospitalization beyond the 30-day post-palivizumab cut point for each group in the IMpact study? Although the published study design may have provided an adequate outcome to demonstrate drug efficacy for Food and Drug Administration approval, failure to consider RSV hospitalization later in the epidemic (beyond 30 days after the fifth dose of palivizumab) would likely result in a discrepancy in palivizumab's true effectiveness in actual clinical practice compared with its efficacy under ideal study conditions of the randomized clinical trial. In addition, under actual clinical practice conditions, one would not anticipate palivizumab to be as effective as described under efficacy study conditions for other reasons such as missing or untimely palivizumab injections. Furthermore, under the IMpact study conditions, the control group may have been exposed to RSV infection to an extent greater than had they not participated in the study. The general study conditions of the 139 centers where patients waited until . . . [Full Text of this Article]


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