Topical tacrolimus in atopic dermatitis: Effects of ... - Helda - Helsinki.fi

acetate on the face and neck versus pimecrolimus, reported equal efficacy compared to
that of the corticosteroid arm. However, no intention-to-treat analysis was done, and the
discontinuation rate in the pimecrolimus group was 60% (Luger et al. 2004). In studies
comparing tacrolimus and pimecrolimus, tacrolimus has shown superior efficacy with a
similar adverse-effect profile (Paller et al. 2005). According to flare control studies,
pimecrolimus cream seems to work best as a corticosteroid-sparing agent (Kapp et al.
2002, Wahn et al. 2002, Meurer et al. 2002 and 2004, Papp et al. 2005, Siegfried et al.
2006).
Evidence-based treatment of AD
AD has undergone various treatments for decades, although evidence-based data on
these treatment modalities is scarce. Evidence-based medicine means treatment based
on sufficient information from high-quality trials. Quality requirements include a welldefined
and sufficiently large patient population and well-defined diagnostic methods
and assessments of AD severity and treatment efficacy. Studies should also reflect
clinical need for treatment so that chronic diseases are investigated in long-term studies.
Studies on treatment of AD have usually been small in patient number, seldom
controlled, or controlled with a poorly validated compound (Hoare et al. 2000).
Topical corticosteroids have been studied mostly in short-term trials, because no
long-term studies have been required by authorities. The quality of the studies varies,
and there are no published placebo-controlled trials for instance of betamethasone 17valerate,
considered a standard comparator for newer topical treatments. However, the
chronic nature of AD calls for long-term controlled trials to find a safe and efficient way
to control the disease. Recently three studies have lasted for 4 to 6 months testing
maintenance therapy for AD with topical corticosteroids twice weekly with favorable
results (Faergemann 2000, Berth-Jones et al. 2003, Hanifin et al. 2002). Intermittent
long-term corticosteroid treatment has been used in two randomized controlled studies
lasting for 6 months: one with tacrolimus ointment and one with pimecrolimus cream
(Reitamo et al. 2005, Luger et al. 2004). At present, these are the only published
corticosteroid controlled long-term studies on the AD treatment.
Data on the placebo-controlled short-term studies and controlled long-term
studies of the most common treatments of AD are presented in Table 1.
In chronic diseases that can severely impair quality of life, such as AD, placebocontrolled
long-term studies without a possibility for rescue therapy are not ethically
acceptable for patients with moderate-to-severe disease. In randomized controlled
studies, the selection criteria for eligible patients are strict, which leads to high
exclusion numbers, and the final study population will then represent only a few types
of the disease. For this reason, generalization of the results to population level is
problematic, as patients in “real life” present with different types and variable degrees
of the disease. In the recent years, long-term studies in “real-life” settings, where effects
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