Dupilumab Improves Patient-Reported Outcomes (PROs) in a Phase 2 Study in Adults with Moderate-to-Severe Atopic Dermatitis

Atopic dermatitis (AD) is associated with substantial patient burden. Dupilumab, a fully-human monoclonal antibody against the interleukin-4 receptor-α, has demonstrated symptomatic efficacy in AD. 380 adults with moderate-to-severe AD were randomized 1:1:1:1:1:1 to 16-week treatment with subcutaneous placebo or dupilumab 100mg every 4 weeks (q4w), 300mg-q4w, 200mg every 2 weeks (q2w), 300mg-q2w, or 300mg weekly (NCT01859988). Assessments included PROs of Pruritus Numeric Rating Scale (NRS), SCORing Atopic Dermatitis (SCORAD), Patient Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), Dermatology Life Quality Index (DLQI), and EuroQol-5D (EQ-5D). Mean age was 37 years; mean disease duration was 28 years. At 16 weeks, dupilumab significantly reduced itch on NRS (>3-point decrease) in 20% to 54% of patients vs. 8.2% in placebo group (P<0.0005 all doses except 100mg-q4w P<0.05), along with improvements in sleep on items of SCORAD and POEM measures (P<0.0005 all doses except 100mg-q4w). Dupilumab also significantly reduced symptoms of depression and anxiety on HADS; number of patients with scores >11 indicating probable cases of anxiety or depression decreased by 66.7% to 75% in dupilumab groups vs. 22.2% in placebo group (P<0.05 all doses). Quality of life (QOL) improved at all dupilumab doses except 100mg-q4w (DLQI, P<0.0001; and EQ-5D, P<0.05). The most common adverse events (dupilumab doses combined vs. placebo) were nasopharyngitis (20.6% vs. 21.3%), headache (11.1% vs. 3.3%), and injection site reaction (9.5% vs. 3.3%). In adults with moderate-to-severe AD, dupilumab significantly reduced patient-reported itch relative to placebo, with concomitant improvements on PROs that evaluated sleep, mood, and QOL.