Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study.
BACKGROUND
Long-term treatment for atopic dermatitis (AD) using low-dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent exacerbations.


OBJECTIVE
This 12-month, European, multicentre, randomized study investigated if proactive, twice-weekly application of 0.03% tacrolimus ointment can keep AD in remission and reduce the incidence of disease exacerbation (DE) in children.


METHODS
During the initial open-label period, 267 children with AD applied 0.03% tacrolimus ointment twice daily for up to 6 weeks to all 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 receive tacrolimus (n=125) or vehicle ointment (n=125) twice weekly for 12 months. Exacerbations were treated with 0.03% tacrolimus ointment twice daily until an IGA<or=2 was regained, then randomized treatment was restarted.


RESULTS
The outcome measure was the number of DEs during the DCP that required substantial therapeutic intervention. Proactive application of 0.03% tacrolimus ointment significantly reduced the number of DEs during the DCP that required substantial therapeutic intervention (median difference: 1.0; P<0.001; Wilcoxon rank-sum test), the percentage of DE treatment days (median difference: 6.2; P<0.001; Wilcoxon rank-sum test), and increased the time to first DE requiring intervention (median: 173 vs. 38 days; P<0.001; stratified log-rank test). Differences in quality of life scores were not significant between groups. The adverse event profile was similar for both treatment approaches.


CONCLUSIONS
Twice-weekly proactive application of 0.03% tacrolimus ointment over 12 months was effective for most paediatric study patients in preventing, delaying and reducing the occurrence of AD exacerbations.
Thaçi
D
D
Department of Dermatology and Venerology, J.W. Goethe University, Theodor-Stern-Kai 7, Frankfurt, D-60596 Germany. thaci@em.uni-frankfurt.de
Reitamo
S
S
Gonzalez Ensenat
M A
MA
Moss
C
C
Boccaletti
V
V
Cainelli
T
T
van der Valk
P
P
Buckova
H
H
Sebastian
M
M
Schuttelaar
M L
ML
Ruzicka
T
T
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004643:Emollients / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D004643:Emollients; D007166:Immunosuppressive Agents; D016559:Tacrolimus