Twice‐daily versus Once‐daily Applications of Pimecrolimus Cream 1% for the Prevention of Disease Relapse in Pediatric Patients with Atopic Dermatitis

Abstract

The aim of this study is to compare twice-daily and once-daily applications of pimecrolimus cream 1% for prevention of atopic dermatitis relapses in pediatric patients. This multicenter trial enrolled 300 outpatients aged 2 to 17 years, with mild-to-severe atopic dermatitis. The patients were initially treated with twice-daily topical pimecrolimus until complete clearance or for up to 6 weeks (open-label period). Those who achieved a decrease of at least 1 point in the Investigator's Global Assessment score were then randomized to double-blind treatment with pimecrolimus cream 1% either twice daily or once daily for up to 16 weeks. Study medication was discontinued during periods of disease remission (Investigator's Global Assessment = 0). The primary efficacy end point of the double-blind phase was disease relapse (worsening requiring topical corticosteroids or additional/alternative therapy and confirmed by Investigator's Global Assessment score > or = 3 and pruritus score > or = 2). Of the 300 patients enrolled in the study, 268 were randomized to treatment with pimecrolimus cream 1% either twice daily or once daily (n = 134 in each group). The relapse rate was lower in the twice-daily dose group (9.9%) than that in the once-daily dose group (14.7%), but analysis of the time to disease relapse, using a Cox proportional model to adjust for confounding variables, did not show a statistically significant difference between treatment arms (hazard ratio: 0.64; 95% CI: 0.31-1.30). Treatment of active atopic dermatitis lesions with pimecrolimus cream 1% twice daily, followed by the once-daily dosing regimen, was sufficient to prevent subsequent atopic dermatitis relapses over 16 weeks in pediatric patients.

How are eczema ‘flares’ defined? A systematic review and recommendation for future studies

“…). Of 314 articles identified in the updated search, 41 relevant papers were reviewed in full, leading to the inclusion of 18 new papers published since our previous review . Four papers were excluded as they reported subgroup analyses for previously published studies included in our last review.…”

“…The most frequently used category for flare definitions was the use of an arbitrary cut‐off on an existing severity scale measured at sequential intervals by doctors, which was used in 11 studies (Table ). Eight studies used a composite definition – comprising a number of domains such as investigator's assessment and the perceived need for treatment . Six of the studies used a behavioural definition, which was typically based around the need to change therapy from either a patient's or a physician's perspective.…”

Efficacy and Safety of Tacrolimus versus Pimecrolimus for the Treatment of Atopic Dermatitis in Children: A Network Meta-Analysis

“…The remaining 21 articles met all entry criteria and were included in the network meta-analysis. Among these studies, 3 articles were dual submissions and 1 study was divided into two comparisons; thus, only 19 [8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25] treatment comparisons were included. The screening process is illustrated in figure 2.…”

Current Views on the Pathogenesis and Principles of External Treatment of Atopic Dermatitis in Children

“…Таким образом, пимекролимус является препаратом выбора как стероидсберегающее средство наружного применения, он также может использоваться в качестве местного проти-вовоспалительного средства первой линии на коже лица и в крупных складках кожи [49,51,52]. Пимекролимус может использоваться как в случае обострений, так и для снижения риска рецидивов в области ранее пораженной кожи в качестве средства проактивной поддерживающей интермиттирующей терапии [53][54][55]: так, исследования с участием детей и подростков показали, что длительная проактивная терапия с использованием пимекролимуса снижает риск рецидивов заболевания [56][57][58]. Одним из самых крупных исследований эффектив-ности и безопасности пимекролимуса является иссле-дование Petite, в котором принимали участие около 2500 детей, начиная с 3-месячного возраста (дети полу-чали лечение и наблюдались в течение первых 5-6 лет жизни).…”