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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.
J Am Acad Dermatol. 2005 May; 52(5):810-22.JA

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 < or = .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 < or = .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.

Authors+Show Affiliations

Northwestern University Medical School/Children's Memorial Hospital, Chicago, Illinois 60611-2923, USA. apaller@northwestern.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15858471

Citation

Paller, Amy S., et al. "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." Journal of the American Academy of Dermatology, vol. 52, no. 5, 2005, pp. 810-22.
Paller AS, Lebwohl M, Fleischer AB, et al. 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. J Am Acad Dermatol. 2005;52(5):810-22.
Paller, A. S., Lebwohl, M., Fleischer, A. B., Antaya, R., Langley, R. G., Kirsner, R. S., Blum, R. R., Rico, M. J., Jaracz, E., Crowe, A., & Linowski, G. J. (2005). 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. Journal of the American Academy of Dermatology, 52(5), 810-22.
Paller AS, et al. 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. J Am Acad Dermatol. 2005;52(5):810-22. PubMed PMID: 15858471.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Paller,Amy S, AU - Lebwohl,Mark, AU - Fleischer,Alan B,Jr AU - Antaya,Richard, AU - Langley,Richard G, AU - Kirsner,Robert S, AU - Blum,Robin R, AU - Rico,M Joyce, AU - Jaracz,Eileen, AU - Crowe,Andrew, AU - Linowski,Gregory J, AU - ,, PY - 2005/4/29/pubmed PY - 2006/4/25/medline PY - 2005/4/29/entrez SP - 810 EP - 22 JF - Journal of the American Academy of Dermatology JO - J. Am. Acad. Dermatol. VL - 52 IS - 5 N2 - 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 < or = .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 < or = .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. SN - 1097-6787 UR - https://www.unboundmedicine.com/medline/citation/15858471/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S019096220404229X DB - PRIME DP - Unbound Medicine ER -