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).