Thomson J, et al. - Authors compared the long-term effectiveness and safety of dupilumab with medium-potency topical corticosteroids (TCS) vs placebo with TCS in adults with moderate-to-severe atopic dermatitis (AD). AD was seen to be improved with dupilumab treatment added to TCS up to week 52 compared to TCS alone, and it was demonstrated to be acceptable and safe.

Methods

• Experts conducted this multicentre randomized, double-blinded, placebo-controlled trial in hospitals, clinics and academic institutions across 161 sites in 14 countries.
• They randomly assigned (3: 1: 3) the adults with moderate-to-severe AD 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.
• 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 were assessed as co-primary effectineness end points.

Results

• As per the data, 740 patients were included in the trial in total: 319 were randomly assigned to dupilumab once weekly, 106 to dupilumab every 2 weeks and 315 to the placebo arm.
• Findings demonstrated that 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, researchers identified no new safety signals, findings suggested adverse effects 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.
• In the dupilumab groups, rates of conjunctivitis, injection site reactions and local herpes simplex infections were higher vs the placebo group.