Pimecrolimus in atopic dermatitis: Consensus on safety and the need to allow use in infants
Por:
Luger, T, Boguniewicz, M, Carr, W, Cork, M, Deleuran, M, Eichenfield, L, Eigenmann, P, Folster-Holst, R, Gelmetti, C, Gollnick, H, Hamelmann, E, Hebert, AA, Muraro, A, Oranje, AP, Paller, AS, Paul, C, Puig, L, Ring, J, Siegfried, E, Spergel, JM, Stingl, G, Taieb, A, Torrelo, A, Werfel, T, Wahn, U
Publicada:
1 jun 2015
Resumen:
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 10yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (2yr 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 (<2yr 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.
Filiaciones:
Luger, T:
Univ Munster, Dept Dermatol, D-48149 Munster, Germany
Boguniewicz, M:
Natl Jewish Hlth, Dept Pediat, Div Pediat Allergy Immunol, Denver, CO USA
Univ Colorado, Sch Med, Denver, CO USA
Carr, W:
Southern Calif Res, Mission Viejo, CA USA
Cork, M:
Univ Sheffield, Sch Med, Dept Infect & Immun, Acad Unit Dermatol Res, Sheffield, S Yorkshire, England
Deleuran, M:
Aarhus Univ Hosp, Dept Dermatol, DK-8000 Aarhus C, Denmark
Eichenfield, L:
Univ Calif San Diego, Sch Med, Rady Childrens Hosp, Dept Pediat, San Diego, CA 92103 USA
Univ Calif San Diego, Sch Med, Rady Childrens Hosp, Dept Med, San Diego, CA 92103 USA
Eigenmann, P:
Childrens Univ Hosp, Pediat Allergy Unit, Geneva, Switzerland
Folster-Holst, R:
Univ Clin Schleswig Holstein, Dept Dermatol, Kiel, Germany
Gelmetti, C:
Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dept Pathophysiol & Transplantat, Clin Dermatol, Milan, Italy
Gollnick, H:
Otto Von Guericke Univ, Dept Dermatol & Venereol, Magdeburg, Germany
Hamelmann, E:
Ruhr Univ Bochum, Allergy Ctr Ruhr, Bielefeld, Germany
Evangel Krankenhaus Bielefeld, Klin Kinder & Jugendmed, Bielefeld, Germany
Hebert, AA:
Univ Texas Med Sch Houston, Dept Dermatol, Houston, TX USA
Univ Texas Med Sch Houston, Dept Pediat, Houston, TX USA
Muraro, A:
Univ Hosp Padua, Dept Woman & Child Hlth, Food Allergy Referral Ctr, Padua, Italy
Oranje, AP:
Maasstad Hosp, Dept Dermatol, Rotterdam, Netherlands
Dermicis Skin Hosp, Alkmaar, Netherlands
Intermed Dermatol & Hair Clin, Boxmeer, Netherlands
Paller, AS:
Northwestern Univ, Feinberg Sch Med, Dept Dermatol, Chicago, IL 60611 USA
Northwestern Univ, Feinberg Sch Med, Dept Pediat, Chicago, IL 60611 USA
Paul, C:
Univ Toulouse 3, Larrey Hosp, INSERM 1056, Dept Dermatol, F-31062 Toulouse, France
Puig, L:
Hosp Santa Creu & Sant Pau, Dept Dermatol, Barcelona, Catalonia, Spain
Univ Autonoma Barcelona, E-08193 Barcelona, Catalonia, Spain
Ring, J:
Tech Univ Munich, Christine Kuhne Ctr Allergy Res & Educ, Dept Dermatol & Allergol Biederstein, D-80290 Munich, Germany
Siegfried, E:
St Louis Univ, Sch Med, Dept Pediat, St Louis, MO 63104 USA
St Louis Univ, Sch Med, Dept Dermatol, St Louis, MO USA
Spergel, JM:
Univ Penn, Perelman Sch Med, Childrens Hosp Philadelphia, Div Allergy & Immunol,Dept Pediat, Philadelphia, PA 19104 USA
Stingl, G:
Med Univ Vienna, Dept Dermatol, Vienna, Austria
Taieb, A:
Univ Bordeaux, INSERM 1035, Ctr Reference Malad Rares Peau, Serv Dermatol & Dermatol Pediat, Bordeaux, France
Torrelo, A:
Hosp Nino Jesus, Dept Dermatol, Madrid, Spain
Werfel, T:
Hannover Med Sch, Dept Dermatol & Allergy, Hannover, Germany
Wahn, U:
Charite, Dept Pediat Pneumol & Immunol, Berlin, Germany
Green Published, hybrid, Green Accepted
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