Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study.
BACKGROUND
Pimecrolimus cream (Elidel, SDZ ASM 981), a non-steroid inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms reduces the need for topical corticosteroids.


OBJECTIVE
To investigate the efficacy and safety of pimecrolimus cream 1% in the long-term management of adult AD.


METHODS
192 adults with moderate to severe AD were randomised (1:1) for twice daily (b.i.d.) treatment of early signs or symptoms of AD with either pimecrolimus cream 1% or vehicle cream (control group) to prevent progression to flares. Treatment was given as needed for 24 weeks. In the event of flares, a moderately potent corticosteroid (prednicarbate 0.25% cream) was permitted as rescue medication in both groups. The percentage of days on which a topical corticosteroid was used to treat disease flares was the main outcome measure.


RESULTS
Corticosteroid medication was used on 14.2% (95% confidence interval, CI: 8.3-21.1) of the days of the 24-week treatment period in the pimecrolimus group and on 37.2% (95% CI: 30.4-44.0) of the days in the control group (p < 0.001). In total, 44.8% (43/96) of patients in the pimecrolimus group did not experience a flare compared with 18.8% (18/96) of patients in the control group. The median time to first flare was 144 days in the pimecrolimus group and 26 days in the control group (p < 0.001). Pimecrolimus treatment was also associated with improvement in signs and symptoms of AD, pruritus, patients' self-assessment and quality of life.


CONCLUSIONS
Pimecrolimus cream 1% b.i.d. is an effective, well-tolerated, long-term treatment for AD in adults, substantially reducing the number of flares compared to a conventional therapy and consequently reducing or eliminating the need for corticosteroid treatment.
Meurer
Michael
M
Hautklinik, Universitätsklinikum der TU, Dresden, Deutschland. meurer@rcs.urz.tu-dresden.de
Fölster-Holst
Regina
R
Wozel
Gottfried
G
Weidinger
Gottfried
G
Jünger
Michael
M
Bräutigam
Matthias
M
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome
D003879:Dermatologic Agents; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus