Download with Tacrolimus Clinical Experience Ointment in Atopic Dermatitis III

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Safety and Tolerability
of adverse events data during the clinical trial and also due to the longer observation periods; three to four times longer for tacrolimus ointment than for vehicletreated patients. This longer period of observation is a result of the greater number
of patient withdrawals from the vehicle-controlled treatment group. Overall, two to
three times more patients using vehicle discontinued the study prematurely as a result of lack of efficacy. Similarly, for headache a slightly higher incidence was observed with tacrolimus ointment, but the frequency was within that predicted by the
U.S. Centres for Disease Control and Prevention [5]. Again, the higher rate is probably attributable to the longer observation periods for tacrolimus-treated as opposed
to vehicle-treated patients.
Effects of Tacrolimus Ointment on Laboratory Values
No consistent trends or notable differences among the treatment and control groups
have been reported in any laboratory value during the clinical trials programme.
This is consistent with the observation that absorption of tacrolimus is minimal, and
hence there are no significant systemic effects.
Comparison with Topical Corticosteroids
The primary phase III European clinical trial comparing tacrolimus ointment with
corticosteroids was restricted to 3 weeks’ duration to protect patients from potential
adverse side effects associated with corticosteroid use, and in particular from skin
atrophy. Both 0.1% hydrocortisone butyrate ointment and tacrolimus ointment were
well tolerated in this short-term study [24]. The mild burning sensation and pruritus experienced by patients applying tacrolimus occurred less frequently in patients
using hydrocortisone butyrate (Table 8.6). However, the frequency of these effects
declined rapidly in the tacrolimus ointment group, and by week 3 skin burning was
only slightly higher than that observed in the corticosteroid treatment group at the
same time point. Likewise, the incidence of pruritus in tacrolimus-treated patients
followed a similar pattern, and by week 3 the prevalence had markedly decreased
to values similar to those seen in the hydrocortisone butyrate group. The incidence
Table 8.6. Comparison with corticosteroids: skin burning and pruritus
Adverse Event
0.1% hydrocortisone
butyrate ointment (n=186)
0.03% tacrolimus
ointment (n=193)
0.1% tacrolimus
ointment (n=191)
Skin burning*
24,(12.9)
87 (45.1)
113 (59.2)
Pruritus*
18,(9.7)
39 (20.2)
30 (15.7)
* p<0.05 for tacrolimus vs. hydrocortisone butyrate.
151
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