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New Nonsteroidal Medication Pimecrolimus Shows Promise in Eczema Management: Presented at EADV

By Bonnie Darves

BARCELONA, SPAIN -- October 22, 2003 -- The new nonsteroidal medication pimecrolimus may provide long-term relief in children with atopic eczema (AE), according to a new study released here October 16^th at the European Academy of Dermatology & Venerology Congress.

The study's findings may be a boon to physicians who are reluctant to prescribe corticosteroids because of their undesirable and potentially damaging long-term adverse effects, noted lead author Jinn Lube, MD, University Hospital, Geneva, Switzerland.

Corticosteroids have long been the mainstay treatment for AE, and progress toward developing alternatives has been spurred by patients' concerns about adverse effects.

The multicentre, phase IV study of 947 patients, mean age 15 years, was conducted as a follow-up to and earlier 12-month study that assessed the safety and efficacy of 1% pimecrolimus (PC), an inflammatory-cykotine inhibitor cream. Other phase III studies found that 1% PC is an effective treatment for atopic dermatitis (AD) and that it helped reduce flare-up frequency.

In this 6-month study, patients -- 43% of them were aged 2 to 12 -- were treated with a regimen that incorporated PC with other medications such as topical corticosteroids and emollients. Patients were continuously treated with PC as long as symptoms were present, and immediately upon symptom recurrence after symptom-free periods.

Efficacy parameters evaluated included Investigators Global Assessments (IGA) scores for total body and face, and pruritus assessment. Approximately 76% of participants had a mild to moderate IGA total-body rating and 45% had mild to moderate facial ratings at baseline.

The investigators found that PC significantly reduced AE symptoms and that even young patients found the cream easy to use and cosmetically acceptable.

After 1 week of treatment, 53.7% of patients had improved total-body IGA and 61.9% had improved facial IGA. Efficacy improved as the study proceeded, and at end point nearly 70% had improved their pruritus ratings.

For reference purposes, Dr. Lubbe noted that although 69% of participants had expressed concerns at baseline about corticosteroid use, 53% of them used corticosteroids at least once during the study.

The study was supported by Novartis Pharma AG.


[Study title: Clinical Use of Pimecrolimus Cream in Atopic Eczema: a 6-Month Open-Label Trial in 947 Patients. Poster P2.39]

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