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Clinical Efficacy of Topical Tacrolimus
cally administered tacrolimus. Furthermore, in the event of any disease recurrence
it can be re-used on the same area of skin promptly after discontinuation, again
without the fear of any steroid-like side effects occurring.
In patients with persistent xerosis, long-term therapy (on average once or twice
weekly) is recommendable.
Long-Term Efficacy
As atopic dermatitis is a chronic disease, comprehensive long-term studies are required to demonstrate that efficacy is sustained and that the agent is well tolerated
in the long term.
A large European multicentre study assessed the long-term efficacy and safety of
tacrolimus ointment in adults [23]. All patients had moderate to severe AD affecting
5%–60% of their BSA at baseline, and of these approximately half had severe atopic
dermatitis. Patients applied 0.1% tacrolimus ointment twice daily to affected areas
of skin, including face and neck lesions. The higher 0.1% concentration of tacrolimus was used exclusively because the primary objective of this study was to assess
the long-term safety of topical tacrolimus. In total, 316 patients were included in the
study, of whom 200 were scheduled to receive 6 months of treatment only and the remaining 116 to complete 12 months of treatment. Overall, 245 (77.5%) of patients
completed either the scheduled 6 or 12 months of treatment.
The therapeutic effects of topical tacrolimus occurred very rapidly, with the largest improvements observed within the first week of treatment. During this first week,
substantial improvement was seen in the mEASI and the affected BSA. Further clinical improvements were achieved up to month 3, and this level of improvement was
maintained thereafter. The rapid and progressively maintained improvement in
mEASI and reductions in affected BSA are summarised in Fig. 8.8.
Flare Prevention
An additional analysis investigated the number of patients who experienced a flare
during the study treatment period [27].
Patients were considered to have experienced a flare if they a) were withdrawn
from the study due to lack of efficacy or b) required the use of corticosteroids. This
strict definition was chosen because of its clinical relevance to daily treatment practice. In the six-month treatment group, twenty patients (20/200; 10.0%) were withdrawn on account of lack of efficacy (10 patients) or because of the need to administer corticosteroids to control disease flare (10 patients). In the 12-month treatment
group (n=116), 12 patients (10.3%) were withdrawn; three patients required corticosteroids and nine patients experienced lack of efficacy. These data show that 0.1%
tacrolimus ointment effectively prevented flares in 90% of the patients during the
treatment period.