Atopic dermatitis (AD) is a chronic inflammatory disease significantly impacting patients’ quality of life (QoL). While multiple outcome measures exist, a critical gap remains in establishing treatment goals that meaningfully connect improvements in clinician-reported outcome measures (ClinROMs) with patient-reported outcome measures (PROMs). To determine the Eczema Area and Severity Index (EASI) threshold that best corresponds with clinically meaningful and optimal treatment responses in PROMs, linking ClinROMs and PROMs. LIBERTY AD CHRONOS, a randomized controlled trial, included adult patients treated with dupilumab 300 mg every 2 weeks plus topical corticosteroids. In this post-hoc analysis of the trial, repeated-measures regression analysis was used to quantify the relationship between EASI and improvements in PROMs. Most clinically meaningful responses in PROMs were associated with 50–75% EASI improvement from baseline with the greatest impact on achieving clinically meaningful and optimal PROM responses when transitioning from EASI-50 to EASI-75 and minimal additional benefit when transitioning from EASI-75 to EASI-90 and EASI-90 to EASI-100. Two PROM composite end points, encompassing treatment responses in symptoms and QoL, confirmed these findings. This analysis bridges clinician-reported EASI with PROMs, demonstrating that EASI-75 aligns closely with clinically meaningful and optimal treatment responses from the patient perspective, providing a treatment goal that is both meaningful to patients and visually quantifiable for physicians in moderate-to-severe AD Graphical abstract available online. NCT02260986 (registered October 06, 2014). Patients with atopic dermatitis (AD) experience skin rashes and itch, leading to quality-of-life impairment. Impact of AD can be measured using validated scores. Some measurements are performed by clinicians that focus on visible AD signs (including extent and severity of skin rashes) and others are scored through patient questionnaires that capture symptoms and impact on daily life (including itch intensity or quality of life). Treatment success has been defined by achieving meaningful and optimal scores during AD treatment. Eczema Area and Severity Index (EASI) is a clinician-measured score. Reduction (improvement) of the EASI score by 50%, 75%, 90%, or 100% (EASI-50/75/90/100) from treatment start are common AD treatment goals. However, which EASI improvement level corresponds to meaningful and optimal scores in patient-reported measures remains unknown. In this study, we analyzed data from 106 adults with AD who received dupilumab (an advanced treatment that is injected under the skin) along with topical corticosteroids (skin cream or ointment) for 1 year. We aimed to understand the EASI reduction associated with meaningful and optimal scores for six different patient-reported measurements. These included questionnaires on quality of life, frequency of AD problems, patients’ assessment of their disease and treatment, and two itch measurement scales. Our analysis showed that achieving meaningful and optimal scores in patient-reported measures was highly associated with EASI-75, with not much additional benefit observed at EASI-90 or EASI-100. In conclusion, achieving EASI-75 is a suitable AD treatment goal from a clinical standpoint and is perceived by patients as a meaningful improvement.
Eichenfield et al. (Fri,) studied this question.