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Clinical Efficacy of Topical Tacrolimus
Efficacy in Patients with Limited Disease
The tacrolimus ointment clinical trials programme has been conducted in patients
with moderate to severe atopic dermatitis. However, a recent meta-analysis conducted on data from the two vehicle-controlled studies plus a third study of identical design in children [21] investigated the use of tacrolimus ointment in patients
with limited disease [15]. This was defined as moderate atopic dermatitis, with an
EASI score below 10 and less than 25% of BSA affected.
In total, 141 patients participating in the three trials met the enrolment criteria.
The patients had a mean age of 30 years. Both ointment strengths of tacrolimus
(0.03% and 0.1%) were highly effective, with an improvement in the physician’s global evaluation of over 90% recorded for approximately 48% and 45% of patients, respectively, compared with only 15% of vehicle-treated patients (p≤0.004 for either
tacrolimus ointment strength vs. vehicle). Furthermore, an improvement of at least
50% was recorded in over 70% and more than 65% of patients in the tacrolimus
0.03% ointment and 0.1% groups, respectively, compared with 32% of patients in the
vehicle group (p<0.03) for either tacrolimus ointment concentration vs. vehicle). In
fact, as early as week 1, improvement of at least 50% was achieved by more than half
of the tacrolimus-treated patients. Similar findings were observed for improvement
in EASI score and in the percentage of BSA affected. These results confirm that tacrolimus ointment is not only effective in patients with moderate to severe disease, but
also highly effective in patients with more moderate disease.
Comparison with Corticosteroids
The pivotal head-to-head short-term trial comparing tacrolimus ointment with corticosteroid-based therapy was conducted at 27 centres in eight European countries
[24]. The topical corticosteroid chosen for comparison with tacrolimus ointment was
the widely used hydrocortisone butyrate 0.1% ointment, classified as a moderate to
potent corticosteroid in Europe. A total of 570 patients with moderate to severe
atopic dermatitis were randomly assigned to receive corticosteroid (n=186), 0.03%
tacrolimus ointment (n=193), or 0.1% tacrolimus ointment (n=191).
In all three groups, treatment was applied as a thin layer of ointment, twice daily,
to affected areas for the duration of the study. The study was limited to a 3-week
period because the longer exposure to corticosteroids may have placed patients in
the hydrocortisone butyrate group at an unacceptable risk of developing skin atrophy. The mean age of patients in each group was approximately 30 years with a range
of 16–69 years. About 45% of patients were male and over 95% were Caucasian.
Approximately 90% of patients completed the study, and the numbers of patient
withdrawals from each treatment group were similar.
141
Tacrolimus ointment is not
only effective in patients
with moderate to severe
disease, but also highly
effective in patients with
more moderate disease