The British journal of dermatology · 2018
Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal.
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Thomson J, Wernham A G H, Williams H C
Аннотация
AIM: Blauvelt et al. aimed to compare the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids (TCS) vs. placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD).
SETTING AND DESIGN: This multicentre randomized, double-blinded, placebo-controlled trial was conducted in hospitals, clinics and academic institutions across 161 sites in 14 countries.
STUDY EXPOSURE: Adults with moderate-to-severe AD were randomly assigned (3: 1: 3) to receive subcutaneous dupilumab 300 mg once weekly plus TCS, dupilumab 300 mg every 2 weeks plus TCS or placebo plus TCS until week 52.
OUTCOMES: Co-primary efficacy end points were percentage of patients achieving Investigator's Global Assessment (IGA) 0/1 and 2 points or higher improvement from baseline, and Eczema Area and Severity Index 75% improvement from baseline (EASI-75) at week 16.
RESULTS: In total, 740 patients were included in the trial: 319 were randomly assigned to dupilumab once weekly, 106 to dupilumab every 2 weeks and 315 to the placebo arm. At week 16, more patients in the dupilumab groups achieved the co-primary end points: IGA 0/1 [39% (n = 125) once-weekly dosing, 39% (n = 41) every 2 weeks dosing vs. 12% (n = 39) receiving placebo; P < 0·0001] and EASI-75 [64% (n = 204) and 69% (n = 73) vs. 23% (n = 73); P < 0·0001]. While no new safety signals were identified, adverse effects were noted in 261 (83%) of those receiving dupilumab once weekly plus TCS, 97 (88%) receiving dupilumab every 2 weeks plus TCS and 266 (84%) for those receiving placebo plus TCS. Rates of conjunctivitis, injection site reactions and local herpes simplex infections were higher in the dupilumab groups than in the placebo group.
CONCLUSIONS: Blauvelt et al. concluded that dupilumab treatment added to TCS improved AD up to week 52 vs. TCS alone, and also demonstrated acceptable safety.
SETTING AND DESIGN: This multicentre randomized, double-blinded, placebo-controlled trial was conducted in hospitals, clinics and academic institutions across 161 sites in 14 countries.
STUDY EXPOSURE: Adults with moderate-to-severe AD were randomly assigned (3: 1: 3) to receive subcutaneous dupilumab 300 mg once weekly plus TCS, dupilumab 300 mg every 2 weeks plus TCS or placebo plus TCS until week 52.
OUTCOMES: Co-primary efficacy end points were percentage of patients achieving Investigator's Global Assessment (IGA) 0/1 and 2 points or higher improvement from baseline, and Eczema Area and Severity Index 75% improvement from baseline (EASI-75) at week 16.
RESULTS: In total, 740 patients were included in the trial: 319 were randomly assigned to dupilumab once weekly, 106 to dupilumab every 2 weeks and 315 to the placebo arm. At week 16, more patients in the dupilumab groups achieved the co-primary end points: IGA 0/1 [39% (n = 125) once-weekly dosing, 39% (n = 41) every 2 weeks dosing vs. 12% (n = 39) receiving placebo; P < 0·0001] and EASI-75 [64% (n = 204) and 69% (n = 73) vs. 23% (n = 73); P < 0·0001]. While no new safety signals were identified, adverse effects were noted in 261 (83%) of those receiving dupilumab once weekly plus TCS, 97 (88%) receiving dupilumab every 2 weeks plus TCS and 266 (84%) for those receiving placebo plus TCS. Rates of conjunctivitis, injection site reactions and local herpes simplex infections were higher in the dupilumab groups than in the placebo group.
CONCLUSIONS: Blauvelt et al. concluded that dupilumab treatment added to TCS improved AD up to week 52 vs. TCS alone, and also demonstrated acceptable safety.