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A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis.
Br J Dermatol. 2005 Jun; 152(6):1282-9.BJ

Abstract

BACKGROUND

Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects.

OBJECTIVES

In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD.

METHODS

Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3.

RESULTS

By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group.

CONCLUSIONS

Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD.

Authors+Show Affiliations

Department of Dermatology, Helsinki University Central Hospital, Helsinki SF-00250, Finland. sakari.reitamo@hus.fiNo 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)

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

Language

eng

PubMed ID

15948994

Citation

Reitamo, S, et al. "A Multicentre, Randomized, Double-blind, Controlled Study of Long-term Treatment With 0.1% Tacrolimus Ointment in Adults With Moderate to Severe Atopic Dermatitis." The British Journal of Dermatology, vol. 152, no. 6, 2005, pp. 1282-9.
Reitamo S, Ortonne JP, Sand C, et al. A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2005;152(6):1282-9.
Reitamo, S., Ortonne, J. P., Sand, C., Cambazard, F., Bieber, T., Fölster-Holst, R., Vena, G., Bos, J. D., Fabbri, P., & Groenhoej Larsen, C. (2005). A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. The British Journal of Dermatology, 152(6), 1282-9.
Reitamo S, et al. A Multicentre, Randomized, Double-blind, Controlled Study of Long-term Treatment With 0.1% Tacrolimus Ointment in Adults With Moderate to Severe Atopic Dermatitis. Br J Dermatol. 2005;152(6):1282-9. PubMed PMID: 15948994.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis. AU - Reitamo,S, AU - Ortonne,J P, AU - Sand,C, AU - Cambazard,F, AU - Bieber,T, AU - Fölster-Holst,R, AU - Vena,G, AU - Bos,J D, AU - Fabbri,P, AU - Groenhoej Larsen,C, AU - ,, PY - 2005/6/14/pubmed PY - 2005/8/5/medline PY - 2005/6/14/entrez SP - 1282 EP - 9 JF - The British journal of dermatology JO - Br. J. Dermatol. VL - 152 IS - 6 N2 - BACKGROUND: Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. OBJECTIVES: In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD. METHODS: Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3. RESULTS: By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group. CONCLUSIONS: Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD. SN - 0007-0963 UR - https://www.unboundmedicine.com/medline/citation/15948994/A_multicentre_randomized_double_blind_controlled_study_of_long_term_treatment_with_0_1_tacrolimus_ointment_in_adults_with_moderate_to_severe_atopic_dermatitis_ L2 - https://doi.org/10.1111/j.1365-2133.2005.06592.x DB - PRIME DP - Unbound Medicine ER -