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Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical
Eric L Simpson1, Vimal H Prajapati2,3,4,5,6, Yael A Leshem7,8
1Department of Dermatology, Oregon Health and Science University, 3303 S. Bond Avenue, Portland, OR, 97239, USA. simpsone@ohsu.edu.
Dermatology and Therapy
|May 2, 2024
Summary
Upadacitinib monotherapy significantly improved patient-reported outcomes for adults and adolescents with moderate-to-severe atopic dermatitis (AD). This treatment led to rapid and sustained reductions in itch, symptom burden, and improved quality of life over 16 weeks.
Area of Science:
- Dermatology
- Immunology
- Clinical Trials
Background:
- Atopic dermatitis (AD) is a chronic skin condition causing intense itch and significantly impacting patient quality of life (QoL).
- Current treatments aim to alleviate symptoms and improve QoL for individuals with moderate-to-severe AD.
- Upadacitinib, an oral selective Janus kinase inhibitor, is being investigated for its efficacy in AD management.
Purpose of the Study:
- To evaluate the effect of upadacitinib monotherapy on patient-reported outcomes (PROs) in adults and adolescents with moderate-to-severe AD.
- To assess improvements in itch, skin symptoms, sleep, daily activities, emotional state, and QoL over a 16-week treatment period.
- To compare the efficacy of upadacitinib (15 mg and 30 mg) against a placebo in improving various PROs.
Main Methods:
- Integrated analysis of two Phase 3, double-blind, placebo-controlled clinical trials (Measure Up 1 and Measure Up 2).
- Assessed multiple PROs including itch (WP-NRS, SCORAD), symptom severity (AD Symptom Scale), symptom frequency (Patient-Oriented Eczema Measure), sleep and daily activities (ADerm-IS), QoL (DLQI), mental health (HADS), and patient global impressions.
- Data from 1683 patients treated with upadacitinib (15 mg or 30 mg) or placebo were analyzed.
Main Results:
- A significantly higher proportion of patients receiving upadacitinib experienced rapid itch improvement by week 1 compared to placebo (P < 0.001).
- Sustained improvements in itch were observed through week 16, with response rates of 47.1% for 15 mg and 59.8% for 30 mg upadacitinib.
- Upadacitinib demonstrated rapid and sustained improvements across all assessed PROs, including skin pain, sleep, QoL, emotional state, and mental health.
Conclusions:
- Once-daily oral upadacitinib monotherapy significantly improved PROs in adults and adolescents with moderate-to-severe AD compared to placebo.
- Upadacitinib therapy provides rapid and sustained benefits in symptom burden and quality of life for patients with moderate-to-severe AD.
- These findings support upadacitinib as an effective treatment option for improving patient-reported outcomes in moderate-to-severe atopic dermatitis.
