Post‐marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: Positive effects on major symptoms of atopic dermatitis and on quality of life

Background: Topical application of the calcineurin inhibitors pimecrolimus and tacrolimus is a current major advance in the therapy of atopic dermatitis. The aims of this post‐marketing surveillance were: a) to acquire data on the efficacy and tolerability of pimecrolimus ointment (Elidel^®) on a very large cohort of patients from outpatient clinics, and b) to assess changes in their quality of life, a parameter not often considered in previous studies. Patients and methods: Included were 5,665 patients with atopic dermatitis. During the observation period, data on efficacy and tolerability were obtained at the beginning of the study, 3 to 10 days after initiation of therapy and after 4 to 6 weeks. Evaluation of symptoms as well as assessment of efficacy and tolerability were based on linear scales and on the percentage of the body surface area (% BSA) involved. Quality of life was assessed by the German version of the “Dermatology Life Quality Index (DLQI)” or the “Children's Dermatology Life Quality Index (CDLQI)”. Results: In this largest post‐marketing surveillance hitherto performed in Germany, the efficacy of pimecrolimus was judged as “good” by 79.3 % of physicians and by 76.5 % of patients. Tolerability was assessed as “good” by 87.2 % of physicians and by 83.1 % of patients. Major symptoms of atopic dermatitis such as pruritus, erythema or lichenification showed marked reduction after just 3 to 10 days, signalling general improvement of the skin disease. In addition, application of pimecrolimus resulted in a significant improvement of the quality of life scores in both children and adults. Conclusion: The present study demonstrates that the good efficacy and tolerability of pimecrolimus ointment which had been shown in controlled trials: i) could also be demonstrated on a very large cohort of patients with atopic dermatitis when used in the outpatient setting, and ii) were paralleled by a significant improvement in the quality of life.