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Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.

Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial.

Author information

1
Faculty of Medicine, Department of Dermatology, University of Iceland, Reykjavik, Iceland; bsig@hudlaeknastodin.is.
2
Department of Children Allergology and Cardiology, Wroclaw Medical University, Wroclaw, Poland;
3
Department of Medicine, University of Cape Town, Cape Town, South Africa;
4
GZA Campus Sint-Vincentius, Antwerpen, Belgium;
5
Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands;
6
Department of Dermatology, Peking University First Hospital, Beijing, China;
7
Klinik für Kinder und Jugendmedizin, der Ruhruniversität Bochum, Bochum, Germany;
8
Pediatric Care Medical Group, Huntington Beach, California, and University of California, Irvine, California;
9
Laval University, Hôpital Hôtel-Dieu de Québec, Dermatology Unit and Centre de Recherche Dermatologique du Québec Métropolitain, Quebec City, Canada;
10
Department of Pediatrics, Landspitali-University Hospital, Reykjavik, Iceland;
11
Research Institute, Children's Department, Marien-Hospital-Wesel, Wesel, Germany;
12
Pediatric Pulmonology & Allergy Unit, Children's Hospital La Fe, Valencia, Spain;
13
Division of Pediatric Allergy-Immunology, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver, Colorado;
14
Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois;
15
Meda Pharma GmbH & Co. KG, Bad Homburg, Germany;
16
Department of Dermatology and Allergology Biederstein, Christine Kühne-Center for Allergy Research and Education, Technische Universität München, Munich, Germany; and.
17
Department of Dermatology, University of Münster, Münster, Germany.

Abstract

BACKGROUND AND OBJECTIVES:

Atopic dermatitis (AD) primarily affects infants and young children. Although topical corticosteroids (TCSs) are often prescribed, noncorticosteroid treatments are needed because compliance with TCSs is poor due to concerns about their side effects. In this longest and largest intervention study ever conducted in infants with mild-to-moderate AD, pimecrolimus 1% cream (PIM) was compared with TCSs.

METHODS:

A total of 2418 infants were enrolled in this 5-year open-label study. Infants were randomized to PIM (n = 1205; with short-term TCSs for disease flares) or TCSs (n = 1213). The primary objective was to compare safety; the secondary objective was to document PIM's long-term efficacy. Treatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear).

RESULTS:

Both PIM and TCSs had a rapid onset of action with >50% of patients achieving treatment success by week 3. After 5 years, >85% and 95% of patients in each group achieved overall and facial treatment success, respectively. The PIM group required substantially fewer steroid days than the TCS group (7 vs 178). The profile and frequency of adverse events was similar in the 2 groups; in both groups, there was no evidence for impairment of humoral or cellular immunity.

CONCLUSIONS:

Long-term management of mild-to-moderate AD in infants with PIM or TCSs was safe without any effect on the immune system. PIM was steroid-sparing. The data suggest PIM had similar efficacy to TCS and support the use of PIM as a first-line treatment of mild-to-moderate AD in infants and children.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00120523.

KEYWORDS:

atopic dermatitis; children; infant; pimecrolimus; safety; topical corticosteroid

PMID:
25802354
DOI:
10.1542/peds.2014-1990
[Indexed for MEDLINE]
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