RINVOQ (Upadacitinib) Demonstrates Efficacy in Atopic Dermatitis with Head and Neck Involvement: Phase III Trial Analysis
Key Insights
A post-hoc analysis of Phase III trials Measure Up 1 and Measure Up 2 showed RINVOQ's efficacy in treating moderate-to-severe atopic dermatitis (search) (AD).
Upadacitinib demonstrated significant skin clearance in the head and neck region, reduced itch, and improved quality of life compared to placebo at week 16.
The analysis stratified patients by the severity of head and neck involvement, showing consistent benefits across varying degrees of AD severity.
AbbVie (search)'s RINVOQ (upadacitinib) has shown positive results in a post-hoc analysis of the Phase III Measure Up 1 and Measure Up 2 clinical trials, demonstrating its efficacy in treating moderate-to-severe atopic dermatitis (search) (AD), particularly in patients with varying degrees of disease severity in the head and neck areas. The analysis, presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress, highlights the drug's ability to achieve significant skin clearance, reduce itch, and improve the quality of life for patients.
The Measure Up 1 and Measure Up 2 trials were randomized, multicenter, double-blind, parallel-group, placebo-controlled studies. They assessed the efficacy and safety of 15mg or 30mg doses of upadacitinib compared to placebo in adults and adolescents aged 12 years or older who were candidates for systemic treatment. The post-hoc analysis focused on treatment targets such as near-complete skin clearance in the head and neck region (EASI Head & Neck score <1), near-complete skin clearance (EASI 90), no to little itch (WP-NRS 0/1), and minimal or no impact on quality of life (DLQI 0/1).
Key Findings
The analysis revealed that a greater proportion of patients treated with both doses of upadacitinib achieved near-complete skin clearance in the head and neck region, reduced impact on quality of life, and minimal disease activity at week 16 compared to placebo. Minimal disease activity was defined as near-complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1).
Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany, noted, "At 16 weeks, RINVOQ showed efficacy in patients with moderate-to-severe atopic dermatitis (search) with various degrees of head and neck involvement, achieving optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvement on the patients' quality of life measured by DLQI 0/1 in a substantial number of patients."
The specific results from the post-hoc analysis of the Measure Up 1 and Measure Up 2 studies showed:
- EASI Head & Neck Score < 1:
- Moderate head and neck involvement: 67.8% (15 mg upadacitinib) and 75.9% (30 mg upadacitinib) vs. 27.4% (placebo)
- Severe head and neck involvement: 47.2% (15 mg upadacitinib) and 63.2% (30 mg upadacitinib) vs. 10.5% (placebo)
- Minimal Disease Activity (EASI 90 + WP-NRS 0/1):
- No-to-mild head and neck involvement: 37.2% (15 mg upadacitinib) and 48.1% (30 mg upadacitinib) vs. 3.1% (placebo)
- Moderate head and neck involvement: 22.3% (15 mg upadacitinib) and 37.5% (30 mg upadacitinib) vs. 2.0% (placebo)
- Severe head and neck involvement: 24.8% (15 mg upadacitinib) and 37.8% (30 mg upadacitinib) vs. 0.7% (placebo)
- DLQI 0 or 1:
- No-to-mild head and neck involvement: 38.4% (15 mg upadacitinib) and 45.5% (30 mg upadacitinib) vs. 5.7% (placebo)
- Moderate head and neck involvement: 25.3% (15 mg upadacitinib) and 38.0% (30 mg upadacitinib) vs. 4.6% (placebo)
- Severe head and neck involvement: 25.0% (15 mg upadacitinib) and 41.5% (30 mg upadacitinib) vs. 4.3% (placebo)
Impact of Atopic Dermatitis
Atopic dermatitis (search) is a chronic, relapsing inflammatory condition characterized by intense itching and scratching, leading to cracked, scaly, and oozing skin. It affects up to 10% of adults and 24.6% of adolescents. The involvement of the head and neck region is particularly impactful, affecting quality of life and symptom frequency.
Andrew Anisfeld, PhD, vice president, global medical affairs, immunology, AbbVie (search), stated, "Despite taking steps to manage their condition, many patients with atopic dermatitis (search) continue to live with debilitating symptoms, especially in highly visible areas such as head and neck that can intensify one's physical and emotional burden. These data contribute to our ongoing commitment to elevate the standard of care in atopic dermatitis so patients can strive for the best possible outcomes."
Ongoing Research
RINVOQ is currently being investigated in Phase III clinical trials for other immune-mediated inflammatory diseases, including alopecia areata (search), giant cell arteritis (search), hidradenitis suppurativa (search), Takayasu arteritis (search), systemic lupus erythematosus (search), and vitiligo (search). These studies aim to further explore the potential of upadacitinib in addressing unmet medical needs across various dermatological and immunological conditions.