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Journal of the American Academy of Dermatology
Volume 53, n° 4
pages 602-609 (octobre 2005)
Doi : 10.1016/j.jaad.2005.06.013
accepted : 15 June 2005
REPORTS

Pharmacokinetics of topical calcineurin inhibitors in adult atopic dermatitis: A randomized, investigator-blind comparison
 

Zoe Draelos, MD a, , Anjuli Nayak, MD b, David Pariser, MD c, Jerome L. Shupack, MD d, Katie Chon, RPh e, Beatrice Abrams, PhD e, Carle F. Paul, MD f
a From Dermatology Consulting Services, High Point 
b Sneeze, Wheeze, and Itch Associate LLC, Normal 
c Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research Inc 
d New York University Medical Center 
e Novartis Pharmaceuticals Corp, East Hanover 
f Novartis Pharma AG, Basel 

Reprint requests: Zoe Draelos, MD, 2444 N Main St, High Point, NC 27262.

High Point, North Carolina; Normal, Illinois; Norfolk, Virginia; New York, New York; East Hanover, New Jersey; and Basel, Switzerland

Abstract
Objective

We sought to compare pharmacokinetics of pimecrolimus cream 1% and tacrolimus ointment 0.1% in adults with extensive, moderate to severe atopic dermatitis. Secondary end points included efficacy and safety.

Methods

Patients received twice-daily treatment for 13 days. Blood concentrations of pimecrolimus and tacrolimus were measured at days 1, 5, and 13. Treatment success was defined as an Investigators’ Global Assessment score of 0 (clear) or 1 (almost clear).

Results

Tacrolimus was detectable in 36% of blood samples and pimecrolimus was detectable in 12%. In patients with measurable blood drug concentrations, systemic exposure to tacrolimus (mean area under the curve0-10h < 9.7 ng·h/mL; n=7) was higher than to pimecrolimus (mean area under the curve0-10h < 2.5 ng·h/mL; n=2). Whole-body treatment success (day 13) was achieved in 1 of 18 (5.6%) and 2 of 19 (10.5%) patients treated with pimecrolimus and tacrolimus, respectively, and face/neck treatment success in 5 of 18 (27.8%) and 5 of 19 (26.3%) patients, respectively. Patients included in the study were adult patients with severe atopic dermatitis. The results and conclusions drawn from this study population may not be applicable for the majority of patients with atopic dermatitis who have mild to moderate disease.

Conclusion

Pimecrolimus appears to be associated with lower systemic drug exposure than tacrolimus.

The full text of this article is available in PDF format.

Abbreviations used : AD, BSA, IGA, LOQ, TBSA, TCS



 Funding source: Novartis Pharmaceuticals Corp.
Disclosure: Ms Chon and Dr Abrams are employees of Novartis Pharmaceuticals Corp. Dr Paul is an employee of Novartis Pharma AG.



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