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Giornale Italiano di Dermatologia e Venereologia 2020 February;155(1):8-13

DOI: 10.23736/S0392-0488.19.06478-2


lingua: Inglese

Topical tacrolimus in adult atopic dermatitis: a consensus based on a 15-year experience

Piergiacomo CALZAVARA-PINTON 1, Gabriella FABBROCINI 2, Giampiero GIROLOMONI 3, Alessandra MATIUCCI 3, Giuseppe MICALI 4, Maria L. MUSUMECI 4, Cataldo PATRUNO 5, Giovanni PELLACANI 6, Maria Teresa ROSSI 1, Michela CASTELLO 7, Luca STINGENI 8

1 Department of Dermatology, ASST Spedali Civili of Brescia, University of Brescia, Brescia, Italy; 2 Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II, Naples, Italy; 3 Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy; 4 Dermatology Clinic, University of Catania, Catania, Italy; 5 Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy; 6 Department of Dermatology, University of Modena and Reggio Emilia, Reggio Emilia, Italy; 7 Centro Medico Lombardo, Milan, Italy; 8 Section of Dermatology, Department of Medicine, University of Perugia, Perugia, Italy

Atopic dermatitis (AD) is one of the most common cutaneous inflammatory diseases both in adults and in children. It is a chronic, remitting-relapsing dermatitis, primarily managed by dermatologists, but also by allergists and primary care physicians. Due to coexistence of comorbidities, often a multidisciplinary team is required. Topical calcineurin inhibitors (TCIs - i.e. tacrolimus and pimecrolimus) are a class of steroid-sparing, anti-inflammatory agents that have been shown to be efficacious for the treatment of AD acute flares and in maintenance therapy. In particular, the application of tacrolimus ointment twice daily reduces AD severity and pruritus. Moreover, maintenance therapy with an intermittent application of tacrolimus to recurrent skin sites (proactive therapy) decreases frequency and severity of relapses. Many studies have also assessed the efficacy of TCIs in disorders other than AD. Although US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issued a “black box warning” regarding the possible cancerogenic activity of these drugs, there is currently no strong evidence of an increased rate of malignancy in treated patients, and observational data from postmarketing surveillance studies have shown no safety concerns. A panel of dermatologists have thoroughly discussed the use of tacrolimus in AD after 15-year experience. The experts focused on AD flare treatment, maintenance therapy and management of side effects. Consensus was reached on some areas of interest, namely the stages of AD in which tacrolimus is recommended, the amount of drug to be applied, how to manage side effects, and how to improve patient’s compliance. Moreover, the panel of experts recommended to perform randomized clinical trials to confirm the efficacy of tacrolimus off-label use, which led to successful outcomes in other skin diseases.

KEY WORDS: Dermatitis, atopic; Calcineurin inhibitors; Tacrolimus; Lymphoma; Skin neoplasms; Administration, topical

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