403 Achievement of minimal disease activity is associated with improvements in symptoms, quality of life and treatment satisfaction in patients with atopic dermatitis

Abstract

Abstract There is a need for clear criteria to guide treatment decisions and disease management in patients with atopic dermatitis (AD). The recently developed minimal disease activity (MDA) concept aims to optimize AD management through shared decision-making between patients and clinicians in a treat-to-target approach, and is based on consensus recommendations from 87 physicians and insights from 88 patients globally.This study aims to evaluate how achieving MDA affects outcomes in patients with AD. Observed-case data from three phase 3 clinical trials involving adolescents and adults with moderate-to-severe AD were integrated and analysed (NCT03568318, NCT03569293 and NCT03607422). The MDA criteria were applied to clinician-reported measures [Eczema Area and Severity Index (EASI), SCORing of Atopic Dermatitis, validated Investigator Global Assessment, and body surface area] and patient-reported measures [Worst Pruritus Numerical Rating Scale (WP-NRS), Patient-Oriented Eczema Measure, Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain score, Atopic Dermatitis Impact Scale (ADerm-IS) Sleep disturbance score, Hospital Anxiety and Depression Scale and Dermatology Life Quality Index]. Patients were stratified into three mutually exclusive groups by achievement of treatment targets per measurement at week 16: (i) achieving the optimal target (i.e. MDA) criteria [e.g. EASI improvement ≥90% (EASI 90); WP-NRS ≤1], (ii) achieving the moderate but not optimal target criteria [e.g. EASI improvement ≥75% and <90%; WP-NRS improvement (reduction) ≥4 and WP-NRS >1] and (iii) not achieving either target criteria. Among the stratified target groups (optimal, moderate and neither), patients’ symptoms, quality of life, work productivity and treatment satisfaction were assessed based on achieving meaningful clinically important differences in ADerm-SS 7-item total symptom score (ADerm-SS TSS-7; improvement ≥28), ADerm-IS Daily Activities score (improvement ≥14), ADerm-IS Emotional State score (improvement ≥11), percentage-point improvement in Work Productivity and Activity Impairment (WPAI) Overall Work Productivity score and proportion reporting Patient Global Impressions of Treatment of ‘Extremely/Very Satisfied’. Stratified target groups were compared with a chi-squared or t-test for categorical or continuous variables, respectively, based on observed data. This analysis included 2392 patients. Patients in the optimal target (MDA) group based on EASI (EASI 90) vs. those in the moderate or neither target group had a higher proportion reporting meaningful improvements in ADerm-SS TSS-7 (optimal = 82.6% vs. moderate = 56.8% or neither = 27.4%; P < 0.001 for both comparisons), ADerm-IS Daily Activities (87.2% vs. 66.2% or 39.9%; both P < 0.001) and ADerm-IS Emotional State (86.1% vs. 67.1% or 36.8%; both P < 0.001); a greater percentage-point improvement in WPAI Overall Work Productivity (36.8% vs. 29.2% or 16.6%; both P < 0.01); and a higher proportion reporting being very/extremely satisfied with treatment (73.5% vs. 54.0% or 23.5%; both P < 0.001). Patients in the optimal target (MDA) group based on itch (WP-NRS ≤1) vs. those in the moderate or neither target group had a higher proportion reporting meaningful improvements in ADerm-SS TSS-7 (94.3% vs. 79.7% or 19.1%; both P < 0.001), ADerm-IS Daily Activities (97.3% vs. 84.7% or 33.6%; both P < 0.001) and ADerm-IS Emotional State (94.5% vs. 84.5% or 31.7%; both P < 0.001); a greater percentage-point improvement in WPAI Overall Work Productivity [39.7% vs. 35.2% (not significant) or 14.6% (P < 0.001)]; and a higher proportion reporting being very/extremely satisfied with treatment (79.7% vs. 60.5% or 26.8%; both P < 0.001). Trends were similar in other clinician- and patient-reported measures, with patients who achieved MDA generally reporting better outcomes. Achieving MDA from both a clinician and patient perspective was generally associated with greater improvements in AD symptoms, daily activities, emotional state, work productivity and higher satisfaction. These results demonstrate the value of achieving MDA and support implementing MDA in clinical practice to help improve the current standard of AD care.