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Quality-of-Life Differences Approach Significance Between Pimecrolimus and Topical Corticosteroid Treatment of Paediatric Eczema: Presented at AAD

By Bruce Sylvester

WASHINGTON, DC -- February 11, 2004 -- Differences in parent-reported quality-of-life (QoL) between pimecrolimus (Elidel®) and topical corticosteroid for long-term treatment of mild to severe paediatric atopic dermatitis (eczema) approach statistical significance, researchers reported here on February 8^th at the American Academy of Dermatology 62^nd Annual Meeting.

"Every parent wants the highest possible quality of life for a child under medical treatment," said Jennifer Sung, MD, a clinical investigator at Novartis Pharmaceuticals, East Hanover, New Jersey, United States. "This 24-week study adds to the growing evidence that pimecrolimus will have less adverse effects on the quality of young lives than corticosteroids."

Dr. Sung and co-investigators enrolled 275 children aged 3 months to 11 years. Atopic dermatitis affected at least 5% of each subject's total body surface area. The subjects and their parents were blinded and randomised to receive either a pimecrolimus-based (n = 183) or corticosteroid-based (n = 92) therapy. The investigators applied emollients for dry skin, and either pimecrolimus cream 1% or corticosteroid twice daily at any sign of active atopic dermatitis.

For severe flares among corticosteroid subjects, a mid-potency topical corticosteroid was used for the evening treatment, for a maximum of 3 weeks or until complete resolution.

At baseline, all mean demographic and clinical characteristics were similar between the 2 patient cohorts.

Parents completed the Parent's Index of Quality of Life in Atopic Dermatitis (PIQoL-AD) at baseline, at week 12 and at the end point of 24 weeks or at early withdrawal.

At week 24 there was a trend toward a greater improvement in parent-reported QoL in the pimecrolimus-based group, approaching statistical significance. There was a 29.8% and 37.6% improvement from baseline PIQoL-AD scores at weeks 12 and 24, respectively, in the pimecrolimus group, compared with 19.2% and 26.8% improvement in the corticosteroid-based group.

"Our results suggest that parent-reported QoL differences do exist between pimecrolimus and corticosteroid-based treatment regimens," the researchers concluded. Early use of pimecrolimus cream 1% as a long-term management strategy in children with mild to severe atopic dermatitis had a beneficial effect on parent-reported QoL outcomes, which approached statistical significance and is consistent with previous studies."

Pimecrolimus is approved in the United States for the treatment of mild to moderate atopic dermatitis in individuals who are 2 years of age or older and who cannot use or have failed to respond to other therapies.


[Study title: The Quality-of-Life Benefits of Pimecrolimus Cream 1% in the Long-term Management of Mild to Severe Pediatric Atopic Dermatitis. Abstract 236]

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