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Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment.
Allergy. 2008 Jul; 63(7):742-50.A

Abstract

BACKGROUND

Long-term treatment for atopic dermatitis (AD) using low dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent relapses. This 12-month, European, multicentre, randomized study investigated whether the proactive use of 0.1% tacrolimus ointment applied twice weekly can keep AD in remission and reduce the incidence of disease exacerbations (DE).

METHODS

During the initial open-label period, 257 adults with AD applied 0.1% tacrolimus ointment twice daily (b.i.d.) for up to 6 weeks to affected areas. When an Investigator Global Assessment (IGA) score of <or=2 was achieved, the patient entered the disease control period (DCP) and was randomized to either proactive tacrolimus (n = 116) or vehicle ointment (n = 108) twice weekly for 12 months. Exacerbations were treated with 0.1% tacrolimus ointment b.i.d. until an IGA <or=2 was regained, then randomized treatment was restarted. The primary endpoint was the number of DEs during the DCP that required a substantial therapeutic intervention.

RESULTS

Proactive tacrolimus 0.1% ointment application significantly reduced the number of DEs requiring substantial therapeutic intervention (median difference 2; P < 0.001; Wilcoxon rank sum test), the percentage of DE treatment days (median difference: 15.2%; P < 0.001; Wilcoxon rank sum test) and increased the time to first DE (median 142 vs 15 days; P < 0.001; stratified log-rank test). The adverse event profile was similar for the two treatment approaches.

CONCLUSION

A 12-month, twice weekly proactive tacrolimus ointment application was an effective treatment in most study patients which prevented, delayed and reduced the occurrence of AD exacerbations

Authors+Show Affiliations

Department of Dermatology and Allergy, Ludwig-Maximilian University, Munich, Germany.No 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, Phase III
Corrected and Republished Article
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18592619

Citation

Wollenberg, A, et al. "Proactive Treatment of Atopic Dermatitis in Adults With 0.1% Tacrolimus Ointment." Allergy, vol. 63, no. 7, 2008, pp. 742-50.
Wollenberg A, Reitamo S, Girolomoni G, et al. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008;63(7):742-50.
Wollenberg, A., Reitamo, S., Girolomoni, G., Lahfa, M., Ruzicka, T., Healy, E., Giannetti, A., Bieber, T., Vyas, J., & Deleuran, M. (2008). Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy, 63(7), 742-50.
Wollenberg A, et al. Proactive Treatment of Atopic Dermatitis in Adults With 0.1% Tacrolimus Ointment. Allergy. 2008;63(7):742-50. PubMed PMID: 18592619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. AU - Wollenberg,A, AU - Reitamo,S, AU - Girolomoni,G, AU - Lahfa,M, AU - Ruzicka,T, AU - Healy,E, AU - Giannetti,A, AU - Bieber,T, AU - Vyas,J, AU - Deleuran,M, AU - ,, PY - 2008/7/2/pubmed PY - 2008/7/31/medline PY - 2008/7/2/entrez SP - 742 EP - 50 JF - Allergy JO - Allergy VL - 63 IS - 7 N2 - BACKGROUND: Long-term treatment for atopic dermatitis (AD) using low dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent relapses. This 12-month, European, multicentre, randomized study investigated whether the proactive use of 0.1% tacrolimus ointment applied twice weekly can keep AD in remission and reduce the incidence of disease exacerbations (DE). METHODS: During the initial open-label period, 257 adults with AD applied 0.1% tacrolimus ointment twice daily (b.i.d.) for up to 6 weeks to affected areas. When an Investigator Global Assessment (IGA) score of <or=2 was achieved, the patient entered the disease control period (DCP) and was randomized to either proactive tacrolimus (n = 116) or vehicle ointment (n = 108) twice weekly for 12 months. Exacerbations were treated with 0.1% tacrolimus ointment b.i.d. until an IGA <or=2 was regained, then randomized treatment was restarted. The primary endpoint was the number of DEs during the DCP that required a substantial therapeutic intervention. RESULTS: Proactive tacrolimus 0.1% ointment application significantly reduced the number of DEs requiring substantial therapeutic intervention (median difference 2; P < 0.001; Wilcoxon rank sum test), the percentage of DE treatment days (median difference: 15.2%; P < 0.001; Wilcoxon rank sum test) and increased the time to first DE (median 142 vs 15 days; P < 0.001; stratified log-rank test). The adverse event profile was similar for the two treatment approaches. CONCLUSION: A 12-month, twice weekly proactive tacrolimus ointment application was an effective treatment in most study patients which prevented, delayed and reduced the occurrence of AD exacerbations SN - 1398-9995 UR - https://www.unboundmedicine.com/medline/citation/18592619/Proactive_treatment_of_atopic_dermatitis_in_adults_with_0_1_tacrolimus_ointment_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=18592619.ui DB - PRIME DP - Unbound Medicine ER -