Disrupted Skin Barrier is Associated with Burning Sensation after Topical Tacrolimus Application in Atopic Dermatitis

Seo, Seong Rak; Lee, Seon Gu; Lee, Hee Jung; Kim, Dong Hyun

doi:10.2340/00015555-2699

Cited by 13 publications

(12 citation statements)

References 10 publications

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“…5,6 These AEs are reported more commonly in adults than children, are transient (resolving within 1 week of treatment as the skin barrier improves and the AD lesions heal), have an intensity associated with disease severity, [5][6][7][8][9] and infrequently lead to discontinuation (at a rate of < 5%). 1,6,[10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] Skin burning can be mitigated by mixing TCIs with a moisturizer in a 1:1 ratio, 7 precooling the TCI in the refrigerator for 15 to 20 minutes prior to application, and using emollients to manage AD. [29][30][31][32][33] In adults, taking acetylsalicylic acid 500 mg 1 hour prior to applying topical tacrolimus during the first few days of treatment may prevent severe burning and erythema.…”

Section: Methodsmentioning

confidence: 99%

What Is the Risk of Harm Associated With Topical Calcineurin Inhibitors?

Hanna¹,

Zip

Shear

2019

J Cutan Med Surg

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The topical calcineurin inhibitors (TCIs), tacrolimus (Protopic) and pimecrolimus (Elidel), were approved in the early 2000s and were widely used as a nonsteroid treatment for atopic dermatitis (AD) in adult and pediatric populations. In 2005, the addition of a boxed warning was mandated for TCIs based on a potential risk of malignancy, and there was subsequently a substantial decline in their use. Since then, evidence has mounted to support the safety of this class of medications and suggests that the increased risk of malignancy remains theoretical. This review aims to dispel some of the common myths surrounding the safety of TCIs by evaluating the key evidence regarding their safety and tolerability in adult and pediatric populations. Four major themes are addressed in a practical question-and-answer format: the risk of harm associated with TCIs including common and serious adverse events; warnings and precautions for their use including the risk of systemic absorption, immunosuppression, and malignancy; the comparative safety of TCIs; and suggestions for counselling patients about the risk of harm with TCIs. Based on the available evidence, international professional dermatological organizations and regulatory authorities have concluded that the benefits of TCIs outweigh their potential risks when used in the appropriate patient populations for the recommended duration of time.

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Section: Methodsmentioning

confidence: 99%

What Is the Risk of Harm Associated With Topical Calcineurin Inhibitors?

Hanna¹,

Zip

Shear

2019

J Cutan Med Surg

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“…39,40 This sensation, which is likely related to mast cell activity, has an intensity associated with disease severity and long-term previous therapy with corticosteroids. 39,40 This sensation, which is likely related to mast cell activity, has an intensity associated with disease severity and long-term previous therapy with corticosteroids.…”

Section: Burning Sensation Managementmentioning

confidence: 99%

“…39,40 This sensation, which is likely related to mast cell activity, has an intensity associated with disease severity and long-term previous therapy with corticosteroids. 40,42 If necessary, the administration of non-steroidal anti-inflammatory drug (e.g. 40,42 If necessary, the administration of non-steroidal anti-inflammatory drug (e.g.…”

Section: Burning Sensation Managementmentioning

confidence: 99%

“…Some patients, almost all cases in adults, experience a burning sensation during TCI therapy. 39,40 This sensation, which is likely related to mast cell activity, has an intensity associated with disease severity and long-term previous therapy with corticosteroids. 41 It is noteworthy that the burning sensation tends to resolve within 1 week of treatment initiation, and therefore, patients should be educated to not interrupt therapy with TCIs if this event occurs; by continuing therapy, the skin barrier improves and the intensity of the burning sensation decreases.…”

Section: Burning Sensation Managementmentioning

confidence: 99%

“…41 It is noteworthy that the burning sensation tends to resolve within 1 week of treatment initiation, and therefore, patients should be educated to not interrupt therapy with TCIs if this event occurs; by continuing therapy, the skin barrier improves and the intensity of the burning sensation decreases. 40,42 If necessary, the administration of non-steroidal anti-inflammatory drug (e.g. ibuprofen) or paracetamol can be recommended during the first days of treatment with tacrolimus to reduce the burning sensation.…”

Section: Burning Sensation Managementmentioning

confidence: 99%

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Position statement: topical calcineurin inhibitors in atopic dermatitis

Remitz

Pità

Mota

et al. 2018

Acad Dermatol Venereol

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Background Atopic dermatitis (AD) is a common inflammatory skin disease in both adults and children. Whilst topical calcineurin inhibitors (TCIs), tacrolimus ointment and pimecrolimus cream, have proven efficacy for the treatment of AD, it is important to involve experts to obtain their opinion on its optimal treatment. Objective Using a modified Delphi approach, this project aimed to generate consensus amongst experts on the use of TCIs in the treatment of AD, with a focus on the differentiation between tacrolimus and pimecrolimus. Methods Six expert dermatologists from different European countries participated in this project based on their experience with AD and its treatment, which was evaluated by literature analysis and expert opinion. Consensus amongst the experts was generated using a modified Delphi approach, consisting of three distinct phases, during which a web meeting (June 2017), two online rounds of blinded Delphi voting (July–September 2017) and a face‐to‐face meeting (November 2017) were conducted. The consensus statements concerned two main topics: (i) Background of AD; and (ii) TCIs in AD. Hot topics in the treatment of AD not supported by meta‐analysis, clinical trials or large observational studies were also discussed based on clinical experience. Results In total, 25 consensus statements were defined and validated: eight statements on the general background of AD and 17 statements on the use of TCIs in AD, including their mechanism of action and therapeutic indications in AD, efficacy in adult and paediatric AD patients, pharmacokinetics, incidence of adverse events and safety concerns. Hot topics on the use of TCIs for the treatment of AD included cream vs. ointment, dosages, TCIs contact allergy, burning sensation management, superinfection and vaccination concerns. Conclusion Topical calcineurin inhibitors are a suitable therapy for AD, and selection of the specific TCI should be based on factors which differentiate tacrolimus from pimecrolimus.

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Genetic variations and clinical features associated with burning sensation due to topical tacrolimus in patients with atopic dermatitis

Lee,

Kang,

Kim

et al. 2024

JEADV Clinical Practice

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BackgroundTopical tacrolimus has been used as one of the treatment options for atopic dermatitis (AD). A burning sensation is the most common side effect of topical tacrolimus.ObjectivesThis study was designed to identify genetic variations and clinical features to predict burning sensation by topical tacrolimus in patients with AD.MethodsPatients with AD who had applied topical tacrolimus were classified according to the presence of a burning sensation. We compared the patients' demographics and blood test results, including serum eosinophil, serum immunoglobulin E and multiple allergen simultaneous test. Furthermore, the frequency of variations in barrier‐ (KLK7, FLG 3321delA, FLG K4022X, SPINK5 1156, SPINK5 1188, SPINK5 2475) and immune response‐ (DEFB1, KDR, CDKAL1, IL‐5RA, IL‐9, IL‐12RB1, IL‐12RB2, IL‐17RA) related genes was compared between two groups by reverse blot hybridization assay of the buccal mucosa.ResultsAmong 206 patients with AD using topical tacrolimus, 34 (16.5%) complained of a burning sensation. The burning sensation was associated with severe AD and a family history of atopic disease. Furthermore, with statistical significance, a heterozygous mutation in the filaggrin gene (FLG K4022X) was more frequent in AD patients with a burning sensation due to topical tacrolimus. However, no other significant genetic differences were observed between them.ConclusionsA burning sensation caused by topical tacrolimus can be expected in AD patients with severe symptoms, a family history of atopy and a genetic variation such as FLG K4022X.

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Disrupted Skin Barrier is Associated with Burning Sensation after Topical Tacrolimus Application in Atopic Dermatitis

Cited by 13 publications

References 10 publications

What Is the Risk of Harm Associated With Topical Calcineurin Inhibitors?

What Is the Risk of Harm Associated With Topical Calcineurin Inhibitors?

Position statement: topical calcineurin inhibitors in atopic dermatitis

Genetic variations and clinical features associated with burning sensation due to topical tacrolimus in patients with atopic dermatitis

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