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Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use.
Pediatrics. 2008 Dec; 122(6):e1210-8.Ped

Abstract

OBJECTIVE

Long-term, safe and effective therapeutic options for managing the chronic relapsing nature of atopic dermatitis are essential for improving patient quality of life. To minimize the risks of continued topical corticosteroid usage and potentially reduce the incidence of flares, we tested the efficacy and safety of a rotational paradigm of initial brief application of topical corticosteroid followed by long-term intermittent application of non-steroidal tacrolimus ointment to previously inflamed sites of dermatitis.

METHODS

In this 2-phase study, patients who were 2 to 15 years of age and had moderate to severe atopic dermatitis were randomly assigned to 4 days of twice-daily double-blind therapy with either alclometasone ointment 0.05% or tacrolimus ointment 0.03% (Phase I acute), followed by up to 16 weeks of twice-daily open-label tacrolimus ointment 0.03% (Phase I short-term). Patients whose disease stabilized underwent new randomization to double-blind tacrolimus ointment 0.03% or vehicle applied once daily, 3 times per week to clinically normal-appearing skin for up to 40 weeks (Phase II). Corticosteroid use was prohibited.

RESULTS

Of 206 randomly assigned patients, 152 completed Phase I; 105 of 152 were randomly assigned into Phase II (68 tacrolimus ointment and 37 vehicle). There were no differences in adverse events between alclometasone and tacrolimus (Phase I) or between tacrolimus and vehicle (Phase II). In the acute period, alclometasone-treated patients showed greater improvement in atopic dermatitis signs and symptoms; thereafter, when all patients applied tacrolimus ointment (short-term), there were no differences. In Phase II, tacrolimus-treated patients had significantly more disease-free days compared with vehicle, significantly longer time to first relapse, and significantly fewer disease relapse days.

CONCLUSIONS

For patients with stabilized moderate to severe atopic dermatitis, long-term intermittent application of tacrolimus ointment to normal-appearing but previously affected skin was significantly more effective than vehicle at maintaining disease stabilization, with a safety profile similar to vehicle.

Authors+Show Affiliations

Department of Dermatology, Northwestern University's Feinberg Medical School/Children's Memorial Hospital, 676 North St Clair St, Suite 1600, Chicago, IL 60611, USA. apaller@northwestern.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19015204

Citation

Paller, Amy S., et al. "Three Times Weekly Tacrolimus Ointment Reduces Relapse in Stabilized Atopic Dermatitis: a New Paradigm for Use." Pediatrics, vol. 122, no. 6, 2008, pp. e1210-8.
Paller AS, Eichenfield LF, Kirsner RS, et al. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008;122(6):e1210-8.
Paller, A. S., Eichenfield, L. F., Kirsner, R. S., Shull, T., Jaracz, E., & Simpson, E. L. (2008). Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics, 122(6), e1210-8. https://doi.org/10.1542/peds.2008-1343
Paller AS, et al. Three Times Weekly Tacrolimus Ointment Reduces Relapse in Stabilized Atopic Dermatitis: a New Paradigm for Use. Pediatrics. 2008;122(6):e1210-8. PubMed PMID: 19015204.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. AU - Paller,Amy S, AU - Eichenfield,Lawrence F, AU - Kirsner,Robert S, AU - Shull,Toni, AU - Jaracz,Eileen, AU - Simpson,Eric L, AU - ,, Y1 - 2008/11/17/ PY - 2008/11/19/pubmed PY - 2009/1/16/medline PY - 2008/11/19/entrez SP - e1210 EP - 8 JF - Pediatrics JO - Pediatrics VL - 122 IS - 6 N2 - OBJECTIVE: Long-term, safe and effective therapeutic options for managing the chronic relapsing nature of atopic dermatitis are essential for improving patient quality of life. To minimize the risks of continued topical corticosteroid usage and potentially reduce the incidence of flares, we tested the efficacy and safety of a rotational paradigm of initial brief application of topical corticosteroid followed by long-term intermittent application of non-steroidal tacrolimus ointment to previously inflamed sites of dermatitis. METHODS: In this 2-phase study, patients who were 2 to 15 years of age and had moderate to severe atopic dermatitis were randomly assigned to 4 days of twice-daily double-blind therapy with either alclometasone ointment 0.05% or tacrolimus ointment 0.03% (Phase I acute), followed by up to 16 weeks of twice-daily open-label tacrolimus ointment 0.03% (Phase I short-term). Patients whose disease stabilized underwent new randomization to double-blind tacrolimus ointment 0.03% or vehicle applied once daily, 3 times per week to clinically normal-appearing skin for up to 40 weeks (Phase II). Corticosteroid use was prohibited. RESULTS: Of 206 randomly assigned patients, 152 completed Phase I; 105 of 152 were randomly assigned into Phase II (68 tacrolimus ointment and 37 vehicle). There were no differences in adverse events between alclometasone and tacrolimus (Phase I) or between tacrolimus and vehicle (Phase II). In the acute period, alclometasone-treated patients showed greater improvement in atopic dermatitis signs and symptoms; thereafter, when all patients applied tacrolimus ointment (short-term), there were no differences. In Phase II, tacrolimus-treated patients had significantly more disease-free days compared with vehicle, significantly longer time to first relapse, and significantly fewer disease relapse days. CONCLUSIONS: For patients with stabilized moderate to severe atopic dermatitis, long-term intermittent application of tacrolimus ointment to normal-appearing but previously affected skin was significantly more effective than vehicle at maintaining disease stabilization, with a safety profile similar to vehicle. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/19015204/Three_times_weekly_tacrolimus_ointment_reduces_relapse_in_stabilized_atopic_dermatitis:_a_new_paradigm_for_use_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=19015204 DB - PRIME DP - Unbound Medicine ER -