Simons FE; Early Prevention of Asthma in Atopic Children Study Group. Ann Allergy Asthma Immunol. 2007;99(3):261–266
PURPOSE OF THE STUDY. To evaluate the effect of long-term treatment with levocetirizine on urticaria in young children with atopic dermatitis (AD).
STUDY POPULATION. The group studied 510 children with severe AD disease (mean Scoring Atopic Dermatitis [SCORAD] index: 30) aged 12 to 24 months at enrollment. This study is from the Early Prevention of Asthma in Atopic Children (EPAAC) study.
METHODS. This was a multicenter, randomized, double-masked, parallel-group, placebo-controlled study. Enrolled children were followed for 18 months on treatment with levocetirizine 0.125 mg/kg or placebo twice daily. The occurrence of urticaria was recorded on diary cards by parents or caregivers and “validated” by study investigators (validation was not explained).
RESULTS. During the 18 months of treatment, 27.5% (70 of 255) of the children receiving levocetirizine experienced urticaria in contrast to 41.6% (106 of 255) of the children receiving placebo (P < .001). The mean number of episodes of urticaria was 0.71 ± 0.11 and 1.71 ± 0.25 in the levocetirizine and control groups, respectively (P < .001). Urticaria was noted on a mean of 4.43 days in levocetirizine-treated patients and 5.36 days in placebo-treated patients (P < .001). For 85% of the children, the urticaria lasted ≤7 days. In 77% of the children with urticaria, the outbreak was associated with food ingestion. No significant adverse effects or long-term adverse effects were noted with active treatment.
CONCLUSIONS. Forty-two percent of highly atopic young children in the EPAAC study had acute urticaria, predominantly associated with food ingestion. Levocetirizine was effective at preventing urticarial outbreaks and had a modest effect treating urticaria, as demonstrated by the decrease in the duration of the episodes.
REVIEWER COMMENTS. In a previous, similar trial (Early Treatment of the Atopic Child [ETAC]) in young children with AD treated with cetirizine, acute urticaria was reported in 16% of the patients treated with placebo and 6% of the patients treated with the antihistamine (Simons FE. J Allergy Clin Immunol. 2001;107:703–706). These patients were less highly atopic than the present study. The current EPAAC study is hindered by the lack of explanation of validation of urticarial episodes. This study has extended knowledge on the safety of cetirizine/levocetirizine for young children with AD and their efficacy in preventing acute urticaria resulting from food allergy.