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Evaluation of SDZ‐ASM 981 [ELIDEL™ (pimecrolimus)] in a trial simulating clinical practice in managing childhood atopic dermatitis
Author(s) -
GrahamBrown Robin
Publication year - 2002
Publication title -
clinical and experimental dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.587
H-Index - 78
eISSN - 1365-2230
pISSN - 0307-6938
DOI - 10.1046/j.1365-2230.2002.104316.x
Subject(s) - medicine , pimecrolimus , atopic dermatitis , eczema area and severity index , adverse effect , regimen , clinical endpoint , randomized controlled trial , pediatrics , calcineurin , dermatology , transplantation
A multicentre clinical trial (Study B313), involving clinicians from countries across Europe, was designed to evaluate the possible role of SDZ‐ASM 981 as one part of a long‐term strategy in the management of childhood atopic dermatitis (AD). The principal feature of the study was a therapeutic regimen in which SDZ‐ASM 981 (or control base) was applied, in addition to routine emollients, to very early signs of inflammation. Topical corticosteroids were available in both arms for active flares of disease. 474 patients were recruited to the active arm and 237 patients to the control arm. The age‐distribution, disease severity at baseline and other major parameters were identical in the two groups. The primary end point of the study was the number of flares after 6 months of treatment. Secondary endpoints included the number of flares at 12 months, also flares assessed against disease severity at 6 and 12 months, the amount of topical corticosteroid used and the effect on Eczema Area and Severity Index (EASI). Safety parameters assessed included adverse events throughout the study, a physical examination and laboratory tests at baseline, 6 and 12 months, and skin recall antigen tests at the end of the study. Of the patients who were enrolled, 24% had discontinued the study in the active arm at 6 months compared with 48% in the control arm. By 12 months these figures were 32% and 52%, respectively. The main reason for discontinuance was lack of efficacy (12% SDZ‐ASM 981; 30% control). There were fewer flares at 6 and 12 months in the active arm than the control arm and the discontinuation rate correlated with the number of flares in the AD. The positive effect of SDZ‐ASM 981 was seen in mild, moderate and severe AD. Patients in the SDZ‐ASM 981 arm used substantially less corticosteroid than those in the control arm. There was a rapid and sustained improvement in EASI in the active arm, approximately twice as great as that seen in the control patients. There was no significant difference in adverse events between the two groups and rates were similar for both bacterial and viral infections. There was no difference seen in the rate of local side‐effects at the site of application of the creams. Skin recall antigen responses were comparable between the two populations at the end of the study. This study has demonstrated a positive effect of SDZ‐ASM 981 in controlling flares of AD in children, in all degrees of severity. The patients treated with SDZ‐ASM 981 used less topical corticosteroid and there was no increase in local or systemic side‐effects.