title: Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial.
abstract: OBJECTIVE
  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.
authors: Faculty of Medicine, Department of Dermatology, University of Iceland, Reykjavik, Iceland; bsig@hudlaeknastodin.is.
authors: Bardur
authors: B
authors: Sigurgeirsson
authors: Department of Children Allergology and Cardiology, Wroclaw Medical University, Wroclaw, Poland;
authors: Andrzej
authors: A
authors: Boznanski
authors: Department of Medicine, University of Cape Town, Cape Town, South Africa;
authors: Gail
authors: G
authors: Todd
authors: GZA Campus Sint-Vincentius, Antwerpen, Belgium;
authors: André
authors: A
authors: Vertruyen
authors: Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands;
authors: Marie-Louise A
authors: ML
authors: Schuttelaar
authors: Department of Dermatology, Peking University First Hospital, Beijing, China;
authors: Xuejun
authors: X
authors: Zhu
authors: Klinik für Kinder und Jugendmedizin, der Ruhruniversität Bochum, Bochum, Germany;
authors: Uwe
authors: U
authors: Schauer
authors: Pediatric Care Medical Group, Huntington Beach, California, and University of California, Irvine, California;
authors: Paul
authors: P
authors: Qaqundah
authors: Laval University, Hôpital Hôtel-Dieu de Québec, Dermatology Unit and Centre de Recherche Dermatologique du Québec Métropolitain, Quebec City, Canada;
authors: Yves
authors: Y
authors: Poulin
authors: Department of Pediatrics, Landspitali-University Hospital, Reykjavik, Iceland;
authors: Sigurdur
authors: S
authors: Kristjansson
authors: Research Institute, Children's Department, Marien-Hospital-Wesel, Wesel, Germany;
authors: Andrea
authors: A
authors: von Berg
authors: Pediatric Pulmonology & Allergy Unit, Children's Hospital La Fe, Valencia, Spain;
authors: Antonio
authors: A
authors: Nieto
authors: Division of Pediatric Allergy-Immunology, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver, Colorado;
authors: Mark
authors: M
authors: Boguniewicz
authors: Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois;
authors: Amy S
authors: AS
authors: Paller
authors: Meda Pharma GmbH & Co. KG, Bad Homburg, Germany;
authors: Rada
authors: R
authors: Dakovic
authors: Department of Dermatology and Allergology Biederstein, Christine Kühne-Center for Allergy Research and Education, Technische Universität München, Munich, Germany; and.
authors: Johannes
authors: J
authors: Ring
authors: Department of Dermatology, University of Münster, Münster, Germany.
authors: Thomas
authors: T
authors: Luger
mesh_terms: D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D006801:Humans; D007223:Infant; D008134:Long-Term Care; D016559:Tacrolimus / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000305:Adrenal Cortex Hormones; D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus
keywords: atopic dermatitis; children; infant; pimecrolimus; safety; topical corticosteroid