Calcineurin Inhibitors
The topical calcineurin inhibitors — tacrolimus ointment 0.1 and 0.03% (FK 506, Protopic®, Astellas) and pime-crolimus cream 1% (SDZ ASM 981, Elidel®, Novartis) — have been specifically developed for the treatment of inflammatory skin diseases, and approv
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3.2.2
N. van Geel, B. Boone, I. Mollet, and J. Lambert
Contents
3.2.2.1 Introduction
3.2.2.1
Introduction ....................................................... 331
3.2.2.2
Mode of Action and Rationale for Use in Vitiligo ..................................................... 331
3.2.2.3
Studies................................................................. 332
3.2.2.4
Tacrolimus and Pimecrolimus Monotherapy ...................................................... 332
3.2.2.5
Combination Therapy ....................................... 332
3.2.2.6
Comparative Studies Between Tacrolimus and Pimecrolimus .............................................. 332
3.2.2.7
General Outcome ............................................... 334
3.2.2.8
Application Scheme ........................................... 334
3.2.2.9
Side Effects ......................................................... 336
The topical calcineurin inhibitors – tacrolimus ointment 0.1 and 0.03% (FK 506, ProtopicÒ, Astellas) and pimecrolimus cream 1% (SDZ ASM 981, ElidelÒ, Novartis) – have been specifically developed for the treatment of inflammatory skin diseases, and approved for the shortterm and intermittent long-term treatment of atopic dermatitis in several countries (including the United States of America and European Union nations) [12, 19, 28, 32, 34, 38]. In contrast to topical steroid, they do not have the risk of local side effects, such as skin atrophy, telangiectasia, and glaucoma after prolonged use. Therefore, they are preferentially used in areas more susceptible to these side effects, such as head and neck region, flexures and genital area [23, 35]. Furthermore, because of the limited percutaneous penetration, significant systemic absorption has not been reported following normal use [1]. However, they are currently much more expensive than topical steroids. Since 2002, the beneficial effect of topical immunomodulators (TIMs) has been reported for patients with vitiligo. How they interfere in vitiligo genesis is still a matter of debate.
3.2.2.10 Safety Issues ....................................................... 336 References ........................................................................... 337
3.2.2.2 Mode of Action and Rationale for Use in Vitiligo
N. van Geel () Department of Dermatology, Ghent University Hospital, Ghent, Belgium e-mail: [email protected]
Tacrolimus and pimecrolimus are topical ascomycin immunomodulating macrolactams, and act as calcineurin inhibitors, affecting the activation/maturation of T-cells, and subsequently inhibit the production of various Th1 and Th2 type of cytokines (IL-2, IL-3,
M. Picardo and A. Taïeb (eds.), Vitiligo, DOI 10.1007/978-3-540-69361-3_2.2, © Springer-Verlag Berlin Heidelberg 2010
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IL-4, IL-5, IL-10, GM-CSF, TNF-α and IFN-g). This has led to speculation that this mechanism may interfere with the autoimmune/inflammatory mediated loss of melanocytes in vitiligo lesions. The inhibition of TNF-α production was suspected by some authors to be e
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