 |
|
SaturdayNovember 5SESSION THREE2:20 – 2:40Click here to return to Dermatology Update 2005 Schedule and Abstracts
Click here to download this abstract as an Adobe Acrobat PDF file |
Sakari ReitamoSince 1994 tacrolimus ointment has been used in clinical studies of atopic dermatitis in 19,000 patients, out which 7,500 have been children. After its introduction as Protopic® ointment, it has been used until March 2005 by approximately 3 million patients with atopic dermatitis in Europe, United States and Canada. Long-term efficacy of intermittent tacrolimus ointment monotherapy has been shown to be superior to standard topical corticosteroid therapy. Comparative 6-week studies have revealed that tacrolimus ointment (Protopic®) is superior in efficacy compared to pimecrolimus cream (Elidel®) in patients with atopic dermatitis, while the number and intensity of adverse events is similar. The most frequent adverse event has been a burning sensation and prolonged itching of the skin, mainly at application sites. When compared to long-term conventional therapy with topical corticosteroids, a slight increase in Herpes simplex virus infections can be observed during the first three months of treatment. After that time point, the incidence of Herpes simplex infection is diminished. During long-term studies of several years no increase in any viral infection has been observed. In accordance to this, no signs of long-term immune suppression has been observed. The number of Staphylococcus aureus colonies decreases rapidly, and there are no signs of other bacterial infections over long-term. Testing the skin for recall antigen reactivity in our patients after tacrolimus treatment has revealed a normalization of the reactivity to bacterial and fungal antigens, suggesting a recovery of the initially decreased Th1-type reactivity typical for patients with atopic dermatitis. This is in line with two recent immunization studies, which revealed a normal immunization response in children with atopic dermatitis treated with tacrolimus ointment. We have also observed a normalization of collagen synthesis and skin thickness, when tacrolimus ointment has been used as intermittent monotherapy in adults treated previously with corticosteroids. Compared to normal population, no increase of skin cancer or lymphomas has been observed over long-term. According to the original label, topical calcineurin inhibitors are second-line treatments in patients who do not adequately respond to first-line treatment. So far, the European authorities have not changed this label. Tacrolimus ointment remains the only therapy which is capable of replacing topical corticosteroids in the majority of patients with atopic dermatitis. Click here to return to Dermatology Update 2005 Schedule and Abstracts |