Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a critical appraisal.

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.