Tacrolimus ointment for the treatment of adult and pediatric atopic dermatitis: Review on safety and benefits

Abstract

Atopic dermatitis (AD) requires long‐term management, mainly with topical anti‐inflammatory agents. Topical corticosteroids (TCS) and tacrolimus ointment (TAC‐O) are recommended as first‐line treatments for AD. However, the long‐term use of TCS is limited by cutaneous adverse events such as skin atrophy. For TAC‐O, Japanese and US labelings were updated in 2003 and 2006, respectively, to include a boxed warning about a theoretical risk of skin cancer and lymphoma in patients treated with topical calcineurin inhibitors. However, TAC‐O has been used worldwide for longer than 15 years to treat adult and pediatric patients with AD. Available data suggest that TAC‐O is effective and well tolerated, and can improve quality of life. TAC‐O has successfully been used in the proactive management of AD consisting of long‐term intermittent use to prevent, delay or reduce the occurrence of AD flares. Systemic drug absorption after TAC‐O application is negligible and unlikely to result in systemic immunosuppression. 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. In the absence of robust evidence, the warning about the carcinogenic potential in the Japanese labeling for TAC‐O does not appear justified and should be reconsidered. This mitigation of description would allow adult and pediatric patients with AD to receive the effective treatment more appropriately.

A Calm, Dispassionate Look at Skin Microbiota in Atopic Dermatitis: An Integrative Literature Review

“…Tacrolimus ointment, which is a very important anti-inflammatory topical drug, is recommended as the first-line treatment for AD with topical corticosteroids [40]. Wongpiyabovorn et al [41] conducted an experiment with nine Thai patients with AD undergoing a 4-week monotherapy with tacrolimus.…”

The IL‐13–OVOL1–FLG axis in atopic dermatitis

“…Standard therapeutics for AD include topical emollients for barrier dysfunction and topical steroids and calcineurin inhibitors for skin inflammation . These conventional treatments are more or less effective in reducing atopic inflammation and itch; however, patient satisfaction and adherence to conventional treatments are generally low, as reported in daily clinics …”

Immunomodulatory effects of tacrolimus (FK506) for the treatment of allergic diseases

“…Atopic dermatitis patients skin lesions show epidermal hyperplasia, T-cell and dendritic cell (DC) infiltrates and increased production of inflammatory mediators with an increase in serum IgE levels (33–36). Topical calcineurin inhibitor tacrolimus has been shown as an effective and alternative therapy for corticosteroids in children and adults (37).…”

“…Atopic dermatitis patients skin lesions show epidermal hyperplasia, T-cell and dendritic cell (DC) infiltrates and increased production of inflammatory mediators with an increase in serum IgE levels (33–36). Topical calcineurin inhibitor tacrolimus has been shown as an effective and alternative therapy for corticosteroids in children and adults (37). Tacrolimus has been shown to suppress Th1/Th2 cell activation, mast cell granulation, primary sensory neurotransmitter release, desensitization of TRPV1 receptor, suppression of IL-31 production, IL-33, ST2 receptor mRNA expression, and suppression of impairment of TLR2/TLR1 balance, and periostin production and reduces itching, scratching behavior and preservation of lamellar liquid crystal reduction in atopic dermatitis (31).…”