Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group.
OBJECTIVE
To investigate the safety and efficacy of using 0.1% tacrolimus ointment for long-term treatment of atopic dermatitis.


METHODS
Open-label, noncomparative study with 6 to 12 months of follow-up.


METHODS
Outpatient departments in 30 study centers in 11 European countries.


METHODS
We enrolled 316 patients aged 18 years and older with moderate to severe atopic dermatitis, 200 for 6 months and 116 for 12 months; 77.5% of patients completed the study.


METHODS
Twice-daily application of 0.1% tacrolimus ointment on all affected skin. Visits were scheduled on day 1; after 1, 2, and 4 weeks of treatment; and monthly thereafter.


METHODS
Safety assessments included monitoring of adverse events, clinical laboratory values, and tacrolimus blood concentrations. Efficacy end points included a combined score (modified Eczema Area and Severity Index) and an investigator's global assessment.


RESULTS
Local irritation, adverse events such as burning sensation (47% of patients), pruritus (24% of patients), and erythema (12% of patients) were common but tended to occur only when initiating treatment. Laboratory values showed no marked changes over time. Systemic absorption was minimal, with the maximum tacrolimus blood concentration being less than 1 ng/mL in 76% of patients. All efficacy end points showed improvement. The mean (SD) modified Eczema Area and Severity Index score was 23.7 (12.6) at day 1, 13.5 (11.3) at week 1, 6.1 (9.2) at month 6, and 6.1 (8.1) at month 12. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively.


CONCLUSIONS
Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Arch Dermatol. 2000;136:999-1006
Reitamo
S
S
Department of Dermatology, University Hospital, Helsinki, Finland. sakari.reitamo@hus.fi
Wollenberg
A
A
Schöpf
E
E
Perrot
J L
JL
Marks
R
R
Ruzicka
T
T
Christophers
E
E
Kapp
A
A
Lahfa
M
M
Rubins
A
A
Jablonska
S
S
Rustin
M
M
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005060:Europe; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007866:Leg; D008297:Male; D008875:Middle Aged; D009333:Neck; D009824:Ointments; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus