Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis.
OBJECTIVE
To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD).


METHODS
A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator-blinded, 6-week study.


RESULTS
Tacrolimus-treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus-treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p=0.0002). Treatment success was also significantly greater among the tacrolimus-treated patients compared with pimecrolimus-treated patients (40% vs 22% at study end; p=0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p=0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application-site burning and application-site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the study due to lack of efficacy (10 vs 1, p=0.005).


CONCLUSIONS
Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
Fleischer
Alan B
AB
Wake Forest University, Winston-Salem, NC, USA. afleisch@wfubmc.edu
Abramovits
William
W
Breneman
Debra
D
Jaracz
Eileen
E
D000279:Administration, Cutaneous; D000328:Adult; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009824:Ointments; D011446:Prospective Studies; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
D007155:Immunologic Factors; D009824:Ointments; C117268:pimecrolimus; D016559:Tacrolimus