[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.


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.


CONCLUSIONS
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.
Sunderkötter
Cord
C
Department of Dermatology and Allergology, University of Ulm, Germany. cord.sunderkoetter@ukmuenster.de
Weiss
Johannes M
JM
Bextermöller
Raphael
R
Löffler
Helena
H
Schneider
Dirk
D
D000293:Adolescent; D065095:Calcineurin Inhibitors; D002648:Child; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D003879:Dermatologic Agents / Q000008:administration & dosage; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015995:Prevalence; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011379:Prognosis; D011788:Quality of Life; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D065095:Calcineurin Inhibitors; D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus