BACKGROUND: Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated. OBJECTIVE: We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse. METHODS:Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment withtacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days. RESULTS: A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P = .003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P = .037). LIMITATIONS: Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial. CONCLUSIONS: Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.
RCT Entities:
BACKGROUND: Intermittent dosing of a topical calcineurin inhibitor for preventing atopic dermatitis (AD) disease relapse in patients with stabilized AD has not been evaluated. OBJECTIVE: We sought to evaluate the long-term efficacy and safety of 3-times-weekly use of tacrolimus ointment in preventing AD disease relapse. METHODS: Adult and pediatric patients with moderate to severe AD who were clear of disease after up to 16 weeks of treatment with tacrolimus ointment were randomized in a double-blind fashion to 3-times-weekly treatment with either tacrolimus ointment (0.03% or 0.1%) or vehicle for 40 weeks. The primary end point was the number of flare-free treatment days. RESULTS: A total of 125 patients were randomized to tacrolimus and 72 patients to vehicle. The mean number of flare-free treatment days was 177 for tacrolimus and 134 for vehicle (P = .003). Median time to first relapse was 169 days for tacrolimus and 43 for vehicle (P = .037). LIMITATIONS: Generalizability to all patients seen in clinic may be limited because only patients who responded to tacrolimus ointment in the stabilization phase were randomized into the maintenance phase of the trial. CONCLUSIONS: Maintenance therapy with tacrolimus ointment was associated with significantly more flare-free days compared with vehicle, and a significantly longer time until first disease relapse.
Authors: Mark G Lebwohl; James Q Del Rosso; William Abramovits; Brian Berman; David E Cohen; Emma Guttman; Anthony J Mancini; Lawrence A Schachner Journal: J Clin Aesthet Dermatol Date: 2013-07
Authors: Robert Sidbury; Wynnis L Tom; James N Bergman; Kevin D Cooper; Robert A Silverman; Timothy G Berger; Sarah L Chamlin; David E Cohen; Kelly M Cordoro; Dawn M Davis; Steven R Feldman; Jon M Hanifin; Alfons Krol; David J Margolis; Amy S Paller; Kathryn Schwarzenberger; Eric L Simpson; Hywel C Williams; Craig A Elmets; Julie Block; Christopher G Harrod; Wendy Smith Begolka; Lawrence F Eichenfield Journal: J Am Acad Dermatol Date: 2014-09-26 Impact factor: 11.527
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