Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug

Kapp, Alexander; Papp, Kim; Bingham, A.; Fölster‐Holst, Regina; Ortonne, Jean‐Paul; Potter, Paul; Gulliver, Wayne; Paul, Carle; Molloy, Stephen; Barbier, Nathalie; Thurston, Mark; Prost, Y. De

doi:10.1067/mai.2002.126500

Cited by 246 publications

(288 citation statements)

References 23 publications

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“…20,27,[30][31][32]44 The favorable safety and tolerability profile of 1% pimecrolimus cream demonstrated in published pediatric studies 35,[37][38][39]43,44 is supported by the data summarized in this review. The combined analysis of the results from 4 pharmacokinetic studies conducted with 35 infants with AD indicated that pimecrolimus blood concentrations after topical applications were consistently low, irrespective of the level of disease severity and percentage of TBSA involved.…”

Section: Discussionmentioning

confidence: 57%

“…In the majority of these studies, [35][36][37][38][39] most of the full clinical benefit was observed within the first 1 week after the start of pimecrolimus treatment and maximal improvement was achieved within 3 months, after which the level of improvement was sustained. The use of 1% pimecrolimus cream decreased markedly between 3 and 9 months of treatment and remained low thereafter (Fig 2), with patients having on average ϳ44% to 57% treatment-free days from the ninth month onward.…”

Section: Patients and Use Of 1% Pimecrolimus Creammentioning

confidence: 99%

“…The results of clinical studies in this population of patients [35][36][37][38][39][40] demonstrated that the use of 1% pimecrolimus cream induces rapid symptom relief, prevents progression to major flares, increases the number of diseasefree days, improves the quality of life of patients and their parents, and is well tolerated. Some of the clinical studies also provided evidence that, at variance with TCSs, 1% pimecrolimus cream retains its clinical effectiveness when used for extended periods 35,38,39 and can be discontinued without any risk of disease rebound. 38 The safety of any new drug is of paramount concern to clinicians and defines the relative value of a new, effective, therapeutic option.…”

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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Pimecrolimus is a calcineurin inhibitor developed for the topical treatment of atopic dermatitis. During the clinical development of 1% pimecrolimus cream, 1133 patients 3 to 23 months of age with mild to severe atopic dermatitis were treated for up to 2 years. The objective of this review is to discuss the safety and tolerability of 1% pimecrolimus cream among infants, on the basis of the combined results from all studies (4 pharmacokinetic studies and 6 clinical trials) conducted among these patients. Pimecrolimus blood concentrations measured for 35 patients were consistently low (Յ1 ng/mL in Ͼ80% of samples), irrespective of the disease severity and extent, and remained low during intermittent treatment for up to 1 year. The level of systemic exposure to pimecrolimus among infants was comparable to that observed for older pediatric patients enrolled in the same studies and treated in the same way with 1% pimecrolimus cream, which indicated that young pediatric patients are not at higher risk of significant percutaneous absorption of topically applied pimecrolimus, despite their large skin surface area/body mass ratio. The 6 clinical trials included a total of 1098 infants, who were treated for periods ranging from 4 weeks to 2 years. Most of these patients (60%) had moderate to severe disease at baseline. The most frequently reported adverse events were common childhood disorders such as nasopharyngitis, pyrexia, upper respiratory tract infections, ear infections, and bronchitis. During the double-blind (DB) studies or DB phases of studies, the incidence rates for the most frequently reported adverse events were similar for patients who received 1% pimecrolimus cream and patients who received the vehicle, except for the incidence of teething, which was higher among the pimecrolimus-treated infants (relative risk: 2.02; 95% confidence interval: 1.32-3.27). Treatment with 1% pimecrolimus cream was not associated with an increase in the overall incidence of nonskin infections, compared with the vehicle (relative risk: 1.015; 95% confidence interval: 0.88 -1.18). The incidence density (ID) rates for total bacterial, fungal, parasitic, and viral skin infections during the DB studies or DB phases of www.pediatrics.org/cgi

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Section: Discussionmentioning

confidence: 57%

Section: Patients and Use Of 1% Pimecrolimus Creammentioning

confidence: 99%

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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“…Также при использовании пимекролимуса отсутствует риск развития атрофии кожи, всасывания через кожу и системного вли-яния; не наблюдается синдрома отмены, характерного для тГКС. В ряде исследований было продемонстрировано, что пимекролимус в виде 1% крема применяется с целью постепенной отмены тГКС при долгосрочном их использо-вании (метод степ-терапии, step-down) [49,51,52]. 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].…”

Section: топические ингибиторы кальциневринаunclassified

“…В ряде исследований было продемонстрировано, что пимекролимус в виде 1% крема применяется с целью постепенной отмены тГКС при долгосрочном их использо-вании (метод степ-терапии, step-down) [49,51,52]. 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].…”

Section: топические ингибиторы кальциневринаunclassified