[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].

Abstract

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.

• Authors: Cord Sunderkötter, Johannes M Weiss, Raphael Bextermöller, Helena Löffler, Dirk Schneider
• Journal: Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG (J Dtsch Dermatol Ges) Vol. 4 Issue 4 Pg. 301-6 (Apr 2006) ISSN: 1610-0379 [Print] Germany
• Vernacular Title: Beobachtungsstudie zur Behandlung der atopischen Dermatitis mit dem Calcineurininhibitor Pimecrolimus an 5665 Patienten: Positive Wirkung auf Leitsymptome der atopischen Dermatitis und auf die Lebensqualität.
• PMID: 16638059 (Publication Type: Clinical Trial, English Abstract, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Calcineurin Inhibitors
• Dermatologic Agents
• pimecrolimus
• Tacrolimus

Topics

• Adolescent
• Calcineurin Inhibitors
• Child
• Child, Preschool
• Dermatitis, Atopic (diagnosis, drug therapy, epidemiology)
• Dermatologic Agents (administration & dosage)
• Female
• Germany (epidemiology)
• Humans
• Infant
• Infant, Newborn
• Male
• Prevalence
• Product Surveillance, Postmarketing (methods)
• Prognosis
• Quality of Life
• Tacrolimus (administration & dosage, analogs & derivatives)
• Treatment Outcome