Topical Calcineurin Inhibitors Labeling: Putting the “Box” in Perspective

Stern, Robert S.

doi:10.1001/archderm.142.9.1233

Cited by 13 publications

(8 citation statements)

References 3 publications

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“…38 However, there are still some strong debates and controversies regarding the exact indications of immunomodulators and their duration of use in the absence of active controlled trials. 39 However, there were no significant adverse events reported by patients in our trial, apart from transient burning sensation in two patients in pimecrolimus group.…”

Section: Discussionmentioning

confidence: 54%

Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus

Gorouhi

Solhpour

Beitollahi

et al. 2007

Journal of the American Academy of Dermatology

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Section: Discussionmentioning

confidence: 54%

Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus

Gorouhi

Solhpour

Beitollahi

et al. 2007

Journal of the American Academy of Dermatology

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“…This market-driven effort prompted an FDA Advisory Group, convened in 2005, to reconsider the risk/benefit profile of these agents and to re-establish their appropriate role in the treatment of AD [83, 84]. Even critics of the FDA's imposition of black box warnings on Elidel ® and Protopic ® acknowledge the strong causal link between systemic (internal) use of these agents and the development of both lymphatic cancers (lymphomas) and UV-induced skin cancers [85].…”

Section: Therapeutic Implicationsmentioning

confidence: 99%

Therapeutic Implications of a Barrier-Based Pathogenesis of Atopic Dermatitis

Elias

Wakefield

2010

Clinic Rev Allerg Immunol

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Excessive Th2 cell signaling and IgE production play key roles in the pathogenesis of atopic dermatitis (AD). Yet, recent information suggests that the inflammation in AD instead is initiated by inherited insults to the barrier, including a strong association between mutations in FILAGGRIN and SPINK5 in Netherton syndrome, the latter of which provides an important clue that AD is provoked by excess serine protease activity. But acquired stressors to the barrier may also be required to initiate inflammation in AD, and in addition, microbial colonization by Staphylococcus aureus both amplifies inflammation, but also further stresses the barrier in AD. Therapeutic implications of these insights are as follows: While current therapy has been largely directed toward ameliorating Th2-mediated inflammation and/or pruritus, these therapies are fraught with short-term and potential long-term risks. In contrast, “barrier repair” therapy, with a ceramide-dominant triple-lipid mixture of stratum corneum lipids, is more logical, of proven efficacy, and it provides a far-improved safety profile.

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“…The FDA raised concerns about the animal data and lack of phase IV studies initiated by the manufacturers of tacrolimus and pimecrolimus and recommended a 'black-box' warning because of the perception of these agents possibly presenting a public health threat. [47] Similarly, due to the paucity of data, the Medicines and Healthcare products Regulatory Agency (MHRA) has stated that TCIs should not be used in malignant or potentially malignant conditions. [48] As topical treatment of LS involves application of these agents at mucosal and mucocutaneous sites, the potential for adverse effects needs to be considered differently from use on the skin.…”

Section: Safety Profile and Adverse Effectsmentioning

confidence: 99%

The Role of Calcineurin Inhibitors in the Management of Lichen Sclerosus

Yesudian

2009

American Journal of Clinical Dermatology

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Lichen sclerosus is a chronic inflammatory disorder with a propensity to affect the mucocutaneous anogenital area. Topical corticosteroids remain the treatment of choice for this condition and constitute an effective therapeutic modality. However, in patients with corticosteroid-resistant disease, when long-term remission is not sustainable, or in those intolerant to these agents, topical calcineurin inhibitors may be considered. Studies have demonstrated their efficacy and tolerability; however, concerns remain with regard to their malignant potential with long-term use. As lichen sclerosus is a potentially precancerous dermatosis, topical calcineurin inhibitors should be used with caution in this disorder.

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Topical Calcineurin Inhibitors Labeling: Putting the “Box” in Perspective

Cited by 13 publications

References 3 publications

Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus

Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus

Therapeutic Implications of a Barrier-Based Pathogenesis of Atopic Dermatitis

The Role of Calcineurin Inhibitors in the Management of Lichen Sclerosus

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