Open-label, pilot study examining sequential therapy with oral tacrolimus and topical tacrolimus for severe atopic dermatitis.
BACKGROUND
Systemic treatment options for generalized atopic dermatitis (AD) are limited. To our knowledge, there have been no prospective trials examining the use of oral tacrolimus, a calcineurin inhibitor, in AD.


OBJECTIVE
We assessed the safety and efficacy of sequential therapy with oral tacrolimus and topical tacrolimus in the treatment of generalized AD using the Eczema Area and Severity Index and the Physician Global Assessment scores as the primary end points.


METHODS
Twelve patients with AD covering at least 50% body surface area were enrolled. Patients in both phases of the study received sequential therapy with oral and topical tacrolimus over a 14-week treatment period. Eczema Area and Severity Index, Physician Global Assessment, and pruritus scores were calculated at each study visit.


RESULTS
Patients recorded a 67% improvement in the Eczema Area and Severity Index score, a 45% improvement in the Physician Global Assessment score, and a 69% reduction in the pruritus score.


CONCLUSIONS
This investigator-initiated, open-label, single-center, proof-of-concept study lacks a large sample size and placebo control group.


CONCLUSIONS
Sequential therapy with oral tacrolimus and topical tacrolimus may be an effective treatment for AD. A large, randomized control study is warranted.
Department of Dermatology and Cutaneous Surgery, University of Miami, Miami Beach, Florida 33139, USA. terrencekeaney@gmail.com
Terrence Colin
TC
Keaney
Tina
T
Bhutani
Priya
P
Sivanesan
Grace D
GD
Bandow
Sari Beth
SB
Weinstein
Lawrence C C
LC
Cheung
Farah
F
Malick
John
J
Koo
D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D065095:Calcineurin Inhibitors; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D010865:Pilot Projects; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D016559:Tacrolimus