Safety and efficacy of pimecrolimus cream 1% in the daily practice: results of a patient self-observation study in patients with atopic dermatitis.
BACKGROUND
Pimecrolimus cream 1% has proven to be well-tolerated and effective in controlled clinical studies in patients with atopic dermatitis (AD). In a 15-week patient self-observation study, safety and efficacy was investigated in the daily practice.


METHODS
3502 patients with AD (mean age 26.2 +/- 18 years, 62% female) received pimecrolimus cream 1% from 810 physicians in the German Federal Republic. The severity of the disease was assessed at baseline, two times during the 15-week observation period and at the end of treatment. Patients recorded daily the degree of erythema and pruritus. At the end of treatment, safety and efficacy were assessed by the physician based on patient's daily records and by the patient.


RESULTS
The percentage of patients with severe or massive AD decreased from 25% to 7%, whereas the percentage of patients without or with mild symptoms increased from 9% to 55%.The efficacy of treatment was rated by physicians as good or very good in 83.5% of cases and by 79% of patients. At baseline 35% of the patients were free of flares as compared to 75% at the end of therapy. Disease control was better in patients who followed the recommended treatment algorithm for pimecrolimus cream. Tolerability was mostly rated as good or very good.


CONCLUSIONS
Treatment with pimecrolimus cream 1% for patients with AD is well-tolerated and effective in daily practice.
Luger
Thomas A
TA
University Dermatology Clinic, Münster, Germany. luger@uni-muenster.de
Gollnick
Harald
H
Schwennesen
Thomas
T
Bextermöller
Raphael
R
Freytag
Siegfried
S
Bräutigam
Matthias
M
D000328:Adult; D003876:Dermatitis, Atopic / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D016353:Self-Examination / Q000706:statistics & numerical data*; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus