Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: Results from 3 randomized, comparative studies - 21/08/11
, Mark Lebwohl, MD b, Alan B. Fleischer, MD c, Richard Antaya, MD d, Richard G. Langley, MD e, Robert S. Kirsner, MD, PhD f, Robin R. Blum, MD b, M. Joyce Rico, MD g, Eileen Jaracz, PharmD g, Andrew Crowe g, Gregory J. Linowski gfor the US/Canada Tacrolimus Ointment Study Group
Reprint requests: Amy S. Paller, MD, Northwestern University, Department of Dermatology, Suite 520, 645 N Michigan Ave, Chicago, IL 60611-2923.Chicago and Deerfield, Illinois; New York, New York; Winston-Salem, North Carolina; New Haven, Connecticut; Halifax, Nova Scotia; and Miami, Florida
Abstract |
Objective |
To compare the efficacy and safety of tacrolimus ointment and pimecrolimus cream in adult and pediatric patients with mild to very severe atopic dermatitis (AD).
Methods |
One thousand and sixty-five patients were randomized to treatment in 3 multicenter, randomized, investigator-blinded, 6-week studies.
Results |
Based on the Eczema Area Severity Index (EASI), tacrolimus ointment was more effective than pimecrolimus cream at the end of the study in adults (54.1% vs. 34.9%, respectively; P < .0001), in children with moderate/severe disease (67.2% vs. 56.4%, respectively; P=.04), in the combined analysis (52.8% vs. 39.1%, respectively; P < .0001), and at week 1 in children with mild disease (39.2% vs. 31.2%, respectively; P=.04). Tacrolimus was also more effective than pimecrolimus based on the Investigator Global AD Assessment (IGADA), improvement in percentage of total body surface area affected, and improvement in itch scores (P ≤ .05), with a faster onset of action. There was no significant difference in the incidence of adverse events (AEs), including application site reactions in the 2 studies involving 650 children. Adults treated with tacrolimus experienced a greater number of local application site reactions on day 1; both groups reported a similar incidence of application site reactions thereafter. More pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the studies because of a lack of efficacy (P ≤ .03) or adverse events (P=.002; pediatric mild).
Conclusion |
Tacrolimus ointment is more effective and has a faster onset of action than pimecrolimus cream in adults and children with AD; their safety profiles are similar.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, BSA, %BSA, EASI, EOS, IGADA, MedDRA, VAS
Plan
| Supported by Fujisawa Healthcare, Inc. Disclosure: Dr Rico, Dr Jaracz, Mr Linowski, and Mr Andrew Crowe are full-time employees of Fujisawa Healthcare, Inc. All other authors served as principal investigators in this study. Drs Paller, Fleischer, and Lebwohl are clinical investigators for Novartis Pharmaceuticals Corp. Drs Fleischer, Langley, and Lebwohl have received research support/grants from Fujisawa Healthcare, Inc. and Novartis Pharmaceuticals Corp. Dr Kirsner has received research support/grants from Fujisawa Healthcare, Inc. Drs Paller and Fleischer served as consultants to Fujisawa Healthcare, Inc. Drs Paller and Langley served as consultants to Novartis Pharmaceuticals Corp. Drs Paller and Antaya are on the Speakers Bureau of Fujisawa Healthcare, Inc. and Novartis Pharmaceuticals Corp. Dr Fleischer is on the Speakers Bureau of Fujisawa Healthcare, Inc. Dr Lebwohl is a funded speaker for Fujisawa Healthcare, Inc. Portions of the information included in this article were presented at the annual meeting of the Society of Pediatric Dermatology, June 2004, and at the World Congress of Pediatric Dermatology, Rome, Italy, July 2004. |
Vol 52 - N° 5
P. 810-822 - mai 2005 Retour au numéro
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