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 withpimecrolimus) 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). CONCLUSION:Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimuscream 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). CONCLUSION:Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
Authors: Lawrence F Eichenfield; Wynnis L Tom; Timothy G Berger; Alfons Krol; Amy S Paller; Kathryn Schwarzenberger; James N Bergman; Sarah L Chamlin; David E Cohen; Kevin D Cooper; Kelly M Cordoro; Dawn M Davis; Steven R Feldman; Jon M Hanifin; David J Margolis; Robert A Silverman; Eric L Simpson; Hywel C Williams; Craig A Elmets; Julie Block; Christopher G Harrod; Wendy Smith Begolka; Robert Sidbury Journal: J Am Acad Dermatol Date: 2014-05-09 Impact factor: 11.527
Authors: Hye One Kim; Yoon Seok Yang; Hyun Chang Ko; Gyung Moon Kim; Sang Hyun Cho; Young Joon Seo; Sang Wook Son; Jong Rok Lee; Joong Sun Lee; Sung Eun Chang; Jae We Che; Chun Wook Park Journal: Ann Dermatol Date: 2015-10-02 Impact factor: 1.444