Pimecrolimus cream 1% in the treatment of intertriginous psoriasis: A double-blind, randomized study - 24/08/11
, Thomas Hultsch, MD i, Alan Menter, MD j
Reprint requests: Anne Parneix-Spake, MD, Novartis Pharmaceuticals Corp, One Health Plaza, East Hanover, NJ 07936.New York, New York; Newman, Georgia; Norfolk, Virginia; High Point, North Carolina; New Brunswick and East Hanover, New Jersey; Miami Beach, Florida; Abbott Park, Illinois; Basel, Switzerland; and Dallas, Texas
Abstract |
Background |
Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion.
Objective |
This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis.
Methods |
This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment.
Results |
A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 (P=.0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was −2.4 (pimecrolimus group) compared with −0.7 (vehicle) at day 3 (P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group (P=.0007). Adverse events were similar between groups.
Conclusion |
Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.
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| Sponsored by Novartis Pharmaceuticals Corp. Disclosure: Drs Parneix-Spake and Hultsch are employees of Novartis. Dr Chen was an employee of Novartis at the time of the study and is currently employed by Abbott Laboratories. Dr Ling received research grants and honoraria from Novartis. Dr Lebwohl or members of the Mount Sinai Dermatology Department received clinical research trial grants from Abbott Laboratories, Allergan, Amgen/Wyeth, Biogen, Centocor, Connectics, Fujisawa, Genentech, GlaxoSmithKline, 3M, and Novartis; is a consultant to Amgen/Wyeth, Biogen, Centocor, and Genentech; and received honorarium from Allergan, Amgen/Wyeth, Biogen, Connectics, Fujisawa, and 3M. Dr Pariser is clinical investigator for Novartis. Dr Draelos received a research grant for this trial from Novartis. Dr Gottlieb is consultant for Novartis but not currently a speaker. Dr Menter received research grants from and is a consultant to Abbott, Allergan, Amgen, Biogen, Centocor, Genentech, Serono, Novartis, and Fujisawa Healthcare Inc (makers of tacrolimus, the other drug in this class). Presented in part at the Caribbean Dermatology Symposium, San Juan, Puerto Rico, January 2004, and International Psoriasis Symposium, Toronto, Ontario, Canada, June 2004. |
Vol 51 - N° 5
P. 731-738 - novembre 2004 Retour au numéro
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