Structured question and outcome prioritisation
The GDG framed the clinical question as “Is the treatment with dupilumab efficacious and safe for adult and adolescent patients with uncontrolled moderate-to-severe AD?” (table 1). Population was defined as patients (≥12 years or older) with confirmed diagnosis of moderate-to-severe AD. Moderate-to-severe disease was defined as an Investigator´s Global Assessment (IGA) score of three or higher at baseline or an Eczema Area and Severity Index (EASI) score of 12 or higher at baseline. AD related outcomes were prioritised by the GDG group using a 1 to 9 scale (7 to 9 critical; 4 to 6 important; 1 to 3 of limited importance), as suggested by the GRADE approach (table 2). The critical outcomes were SCORAD 75; EASI 50 or 75; pruritus and safety (drug-related adverse events (AE) and drug-related serious AE (SAE)). The important outcomes were IGA, resource utilisation, rescue medication use, pain, sleep disturbance, symptoms of anxiety and depression, and Quality of life (QoL) (tables 1 and 2). The GDG also framed a cost-effectiveness question to assess the economic impact of dupilumab versus standard of care or the best standard of care. The selected outcomes of interest were costs, resource use, and the incremental cost-effectiveness ratios (ICERs) per quality adjusted life-years (QALY).