Pimecrolimus in atopic dermatitis : Consensus on safety and the need to allow use in infants
Luger, Thomas (University of Münster. Department of Dermatology)
Boguniewicz, Mark (Division of Pediatric Allergy-Immunology, Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine)
Carr, Warner (Southern California Research)
Cork, Michael (Academic Unit of Dermatology Research, Department of Infection and Immunity, The University of Sheffield, K Floor, The Medical School (RHH Tower))
Deleuran, Mette (Aarhus University Hospital (Aarhus, Dinamarca))
Eichenfield, Lawrence (Departments of Pediatrics and Medicine, University of California, San Diego School of Medicine, Rady Children's Hospital)
Eigenmann, Philippe (Pediatric Allergy Unit, Children's University Hospital)
Fölster-Holst, Regina (Department of Dermatology, University Clinics of Schleswig-Holstein)
Gelmetti, Carlo (Department of Pathophysiology and Transplantation, University of Milan, Clinica Dermatologica, Fondazione I.R.C.C.S. Ca' Granda "Ospedale Maggiore Policlinico")
Gollnick, Harald (Department of Dermatology & Venereology, Otto-von-Guericke University of Magdeburg)
Hamelmann, Eckard (Allergy Center Ruhr, Ruhr-University Bochum, & Evangelisches Krankenhaus Bielefeld, Klinik für Kinder und Jugendmedizin)
Hebert, Adelaide A. (Departments of Dermatology and Pediatrics, The University of Texas Medical School-Houston)
Muraro, Antonella (Food Allergy Referral Centre, Department of Woman and Child Health, University Hospital of Padua)
Oranje, Arnold P. (Intermedica Dermatology and Hair Clinic)
Paller, Amy S. (Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine)
Paul, Carle (Dermatology Department, INSERM 1056, Paul Sabatier University, Larrey Hospital)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Ring, Johannes (Technische Universität München)
Siegfried, Elaine (Departments of Pediatrics and Dermatology, Saint Louis University School of Medicine)
Spergel, Jonathan M. (Children's Hospital of Philadelphia (Pennsilvània))
Stingl, Georg (Department of Dermatology, Medical University of Vienna)
Taieb, Alain (Service de Dermatologie et Dermatologie Pédiatrique Centre de référence pour les maladies rares de la peau, INSERM 1035, Université de Bordeaux)
Torrelo, Antonio (Hospital Infantil Universitario Niño Jesús (Madrid))
Werfel, Thomas (Department of Dermatology and Allergy, Hannover Medical School)
Wahn, Ulrich (Department of Pediatric Pneumology and Immunology, Charite)
Universitat Autònoma de Barcelona

Data:	2015
Resum:	Atopic dermatitis (AD) is a distressing dermatological disease, which is highly prevalent during infancy, can persist into later life and requires long-term management with anti-inflammatory compounds. The introduction of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, more than 10 yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (≥2 yr old) and adults with mild-to-moderate AD. The age restriction was emphasized in a boxed warning added by the FDA in January 2006, which also highlights the lack of long-term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short- and long-term studies including over 4000 infants (<2 yr old). These studies showed that pimecrolimus effectively treats AD in infants, with sustained improvement with long-term intermittent use. Unlike topical corticosteroids, long-term TCI use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for AD treatment especially in sensitive skin areas. Most importantly, the studies of pimecrolimus in infants provided no evidence for systemic immunosuppression, and a comprehensive body of evidence from clinical studies, post-marketing surveillance and epidemiological investigations does not support potential safety concerns. In conclusion, the authors consider that the labelling restrictions regarding the use of pimecrolimus in infants are no longer justified and recommend that the validity of the boxed warning for TCIs should be reconsidered.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Atopic dermatitis ; Eczema ; Infants ; Paediatric ; Pimecrolimus ; Safety ; Tacrolimus ; Topical calcineurin inhibitors ; Topical corticosteroids
Publicat a:	Pediatric Allergy and Immunology, Vol. 26 (april 2015) , p. 306-315, ISSN 1399-3038

DOI: 10.1111/pai.12331
PMID: 25557211

10 p, 285.5 KB

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