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Patient‐reported outcomes in adult atopic dermatitis are useful in both clinical trials and real‐life clinical practice

Atopic dermatitis (AD) represents the most common chronic inflammatory skin disease in the world with a lifetime prevalence of up to 20% and a significant impact on health-related quality of life (HRQoL) of AD patients and family members. AD is characterized by itchy skin lesions, with several clinical features according to age or anatomical region, and a typical relapsing course. The presence of highly visible cutaneous signs, such as redness, flaking and bleeding from scratching are responsible for feelings of embarrassment and shame. Moreover, the chronicity of the condition together with the intense itching and sleep disturbance support the heavy burden that AD places on patients and caregivers, especially in case of moderate-to-severe AD. The significant impact of AD in children and adults on HRQoL as well as bullying at school and career discrimination at work concerns the domains of daily activities, school, work, leisure and personal relationships. Psychiatric comorbidities, including depression, anxiety and suicidal ideation, are more common in individuals affected by AD than in general population, and not only in patients with severe disease but also even among patients with mild-to-moderate AD. In adults, moderate-to-severe AD was associated with worse HRQoL than several other common chronic illnesses including heart disease, diabetes and high blood pressure. Therefore, it is essential to be able to measure this impact for a better clinical and therapeutic management of the patient. Traditional measures used to assess AD severity include Investigator Global Assessments (IGAs), SCORing Atopic Dermatitis (SCORAD) and Eczema Area Severity Index (EASI), which are clinician-reported outcome (ClinRO) measures, based on visual assessment of clinical signs such as extent or severity, by the physician. However, patients often experience the burden of AD much heavier than it can be assessed by traditional tools, which are limited in their ability to accurately assess the impact of the disease in patient’s life. The work of Thyssen et al. examined clinically meaningful improvements in selected patient-reported outcomes (PROs) of JADE COMPARE, a 16-week phase-3 randomized, doubleblinded placebo-controlled trial investigating the safety and efficacy of abrocitinib (200 mg and 100 mg), dupilumab and placebo in adults with moderate-to-severe AD. The article focused on the evaluation of patient-reported outcomes (PROs) to assess AD severity and response to therapy. PROs are systematic monitoring of patients comprises data reported directly by people about their status of health condition, symptoms and quality of life through self-assessing validated questionnaires. Although PRO questionnaires were traditionally developed for clinical trials, in the last years there has been a growing interest to use PROs in real-life clinical practice to monitor the impact of the disease and improve patients’ management. PROs include Dermatology Life Quality Index – DLQI, Patient-Oriented Eczema Measure – POEM, Night Time Itch Scale – NTIS, Pruritus and Symptoms Assessment for Atopic Dermatitis – PSAAD, Patient Global Assessment – PGA, SCORAD, Hospital Anxiety and Depression Scale – HADS and EuroQoL 5-Dimension 5-Level – EQ-5D-5L. In the study of Thyssen et al., significant improvements in PROs with both abrocitinib doses versus placebo were demonstrated, and abrocitinib 200 mg provided numerically greater effects compared to those obtained with dupilumab in patients with moderate-to-severe AD. Moreover, the study emphasized the use of patient experience data in drug evaluation. In conclusion, PROs provide an important complement to ClinROs in both clinical trials and real-life clinical practice to support decision-making, but also for drug development and evaluation. Recent indications of the Food and Drug Administration (FDA) on the use of PROs focused on the increasing use of patient experience data in drug development and evaluation and discourage the use of ClinROs alone.