Palivizumab Prophylaxis in Preterm Infants Reduces Wheezing at Age 3: Presented at ERS
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Palivizumab Prophylaxis in Preterm Infants Reduces Wheezing at Age 3: Presented at ERS

By Evelyn Harvey

VIENNA, Austria -- September 21, 2009 -- Palivizumab prophylaxis in preterm infants can provide long-term protection against serious early childhood wheezing, according to an analysis presented at the 19th Annual Congress of the European Respiratory Society (ERS).

Andrew Campbell, Abbott Laboratories, Abbott Park, Illinois, and colleagues analysed 3-year data from an earlier trial of palivizumab prophylaxis in preterm infants. Previous results indicated that serious early childhood wheezing rates were improved in infants up to 2 years following treatment with palivizumab. Results of the study were presented on September 15.

In the original prospective, multicentre, international study, researchers compared outcomes in 180 patients with serious early childhood wheezing who received palivizumab with 210 who did not receive the drug.

Dr. Campbell and colleagues assessed a subset of patients where follow-up data at 3 years were available.

Of the untreated infants, 139 were not hospitalised. Certain baseline characteristics varied significantly between the treated and untreated groups.

The palivizumab-treated infants had significantly lower mean birth weight and mean gestational age, and had fewer siblings than untreated subjects. Only 30.7% of the untreated infants had RSV antibodies, whereas antibodies were present in 42.9% of palivizumab-treated patients (P < .05).

Serious wheezing was defined as a primary endpoint constituting >=3 episodes of physician-documented wheezing, use of asthma controller medication for >=3 consecutive or >=5 cumulative months, and/or systemic steroid use.

At 3 years post-study enrolment, 13.9% of the children who received palivizumab reported 1 or more episodes of serious wheezing versus 22.4% of untreated children, a significant difference (P = .036).

However, the difference between groups was not statistically significant when the proportion of children with >=3 episodes of physician-documented wheezing were compared (2.2% palivizumab vs 4.8% untreated).

The proportion of palivizumab-treated infants who subsequently received >=1 course of systemic steroids was significantly lower than for the untreated group (P < .05). The use of other asthma-controller medications was numerically lower in the treatment group, but this was not statistically significant. There were no significant differences in outcome at 3 years between untreated infants who had been hospitalised and those who had not.

In this analysis, palivizumab prophylaxis in preterm infants had a statistically relevant impact on incidence rates of serious early childhood wheezing at 3 years. However, no significant difference was observed between groups according to more stringent study definitions of serious early childhood wheezing. A significant reduction in steroid use at 3 years was also observed.

“Additional studies are warranted to confirm this finding and to evaluate the effect of palivizumab on serious early childhood wheezing beyond the third year of life,” concluded the researchers.

Funding for this study was provided by Abbott.

[Presentation title: The Effect of Palivizumab Prophylaxis on Serious Early Childhood Wheezing. Abstract P4001]


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