Impact of Achieving and Maintaining Minimal Disease Activity on Long-Term Patient-Reported Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Post-hoc Analysis from Measure Up 1 and 2

Abstract

The AHEAD (Aiming High in Eczema/Atopic Dermatitis) recommendations defined optimal treatment targets for clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) and established Minimal Disease Activity (MDA) as achievement of optimal treatment targets on ≥1 ClinRO and ≥1 PRO. This study evaluated the impact of achieving and maintaining MDA on long-term PROs in patients with moderate-to-severe atopic dermatitis (AD) using integrated data from two upadacitinib (UPA) phase 3 studies (Measure Up 1; Measure Up 2). Patients from UPA treatment (15mg and 30mg) and placebo arms were pooled. Patient groups were identified based on skin and itch target achievement at week 16: MDA (optimal target) group (≥90% Eczema Area and Severity Index [EASI] improvement + Worst Pruritus Numerical Rating Scale [WP-NRS] score of 0/1) and Moderate-Target group (≥75% EASI improvement + ≥4-point WP-NRS improvement). The proportions of patients achieving optimal PRO scores were reported at week 140 by group, including Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI) 0/1, AD Impact Scale Sleep Impact item 0/1 (Sleep NRS 0/1), Patient-Oriented Eczema Measure 0–2 (POEM 0–2), and AD Symptom Scale Skin Pain 0/1 (Skin Pain NRS 0/1). Among MDA achievers at week 16, maintenance of MDA was examined through week 140 (total 13 study visits). Patients were grouped based on the percentage of visits in which MDA was maintained (cohort 1: ≥80% of visits [11-13 visits]; cohort 2: 50-79% [7-10 visits]; cohort 3: <50% [1-6 visits]). The proportion of participants achieving optimal PRO scores at week 140 was reported across the MDA maintenance cohorts. Response rates were based on observed cases. More patients who achieved MDA (n=380) at week 16 attained optimal PROs at week 140 compared with patients who achieved moderate targets (n=232): DLQI/CDLQI 0/1 (65.6% in MDA group vs 39.5% in Moderate-Target group); Sleep NRS 0/1 (84.7% vs 61.9%); POEM 0–2 (49.0% vs 25.8%); and Skin Pain NRS 0/1 (83.5% vs 61.0%). Among MDA achievers at week 16, patients who achieved and maintained MDA in ≥80% of study visits (cohort 1, n=144) reported the highest proportion of DLQI/CDLQI 0/1 (89.6% compared with cohort 2, n=94: 63.4%; cohort 3, n=142: 26.6%), Sleep NRS 0/1 (97.6%; cohort 2: 88.4%; cohort 3: 59.5%), POEM 0–2 (76.5%; cohort 2: 38.0%; cohort 3: 11.4%), and Skin Pain NRS 0/1 (99.3%; cohort 2: 90.0%; cohort 3: 50.6%). Patients who achieved MDA at week 16 and maintained MDA for >80% study visits through week 140 demonstrated the highest levels of optimal PRO achievement, compared to those who maintained MDA over fewer visits, demonstrating the impact of achieving and maintaining MDA on health-related quality-of-life outcomes.