Skin Clearance and Itch Relief in Black or African American Patients with Moderate-to-Severe Atopic Dermatitis Treated with Upadacitinib: 140-Week Outcomes from Integrated Phase 3 Measure Up 1 and 2 Studies

Abstract

Background: Clinical phenotypes and endotypes of atopic dermatitis (AD) may vary across diverse populations. Although Black or African American patients exhibit a high overall burden of disease, an evidence gap remains in understanding outcomes of advanced therapies in this population.

Objectives: To evaluate the efficacy and safety profile of upadacitinib 15 or 30 mg (UPA15 or UPA30, respectively) once daily monotherapy in Black or African American patients with moderate-to-severe AD.

Methods: This post-hoc integrated analysis of the Measure Up 1 and 2 phase 3 trials (NCT03569293; NCT03607422) included Black or African American patients randomized to double-blinded oral UPA15, UPA30, or placebo for 16 weeks, with 140-week data included from a blinded extension period (daily UPA15 or UPA30). Optimal treatment targets for skin, itch, and quality of life (QoL) improvement included 90% improvement of Eczema Area and Severity Index (EASI 90), validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 (vIGA 0/1), Worst Pruritus Numeric Rating Scale of 0 or 1 (WP-NRS 0/1), and Dermatology Life Quality Index of 0 or 1 (DLQI 0/1). Minimal disease activity (MDA) was defined as simultaneous achievement of EASI 90 and WP-NRS 0/1. Lichenification was assessed as improved EASI and Scoring Atopic Dermatitis (SCORAD) component scores. Clinically meaningful reduction in Patient-Oriented Eczema Measure (ΔPOEM≥4) and impact of AD on sleep (Atopic Dermatitis Impact Scale Sleep domain; ΔADerm-IS Sleep≥12) were assessed. Non-responder imputation was used in the analysis through week 16 and observed cases at weeks 52 and 140. Adverse events were evaluated through weeks 16 and 140.

Results: This analysis included 112 Black or African American patients (UPA15, n=47; UPA30, n=27; placebo, n=38). Demographics were consistent across groups (48.1-61.1% female, mean age 33.2-37.3 years). At week 16, UPA15- and UPA30-treated patients achieved reduction in AD severity and extent (EASI 90: 34.9|57.7%), little-to-no itch (WP-NRS 0/1: 25.6|38.5%), MDA (14.0|34.6%), and no effect on patient’s life (DLQI 0/1: 35.1|34.8%). Patients with moderate-to-severe lichenification demonstrated substantial improvement. Improvements were sustained with long-term treatment. At week 140, 91.7% of UPA15-treated patients achieved EASI 90, 75.0% reported WP-NRS 0/1, 70.8% achieved MDA, and 94.7% experienced clinically meaningful improvement in the impact of AD on sleep. Similar trends were observed for a majority of UPA30-treated patients across most outcome measures. No new safety signals were identified in this racial group.

Conclusion: Black or African American patients treated with upadacitinib achieved optimal targets for skin clearance, itch relief, and QoL. The safety profile was consistent with prior studies, confirming upadacitinib is safe and efficacious as a long-term treatment for moderate-to-severe AD in Black or African American patients.