Thursday, AbbVie Inc (NASDAQ:ABBV) released topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study of upadacitinib (Rinvoq, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (Dupixent, per its labeled dose) for atopic dermatitis.
AbbVie said the study is the first head-to-head trial in atopic dermatitis assessing upadacitinib at a starting dose of 15 mg daily versus dupilumab at its labeled dose.
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The study enrolled adults and adolescents with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when the use of those therapies was inadvisable.
Dupixent is the flagship drug of Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceutical Inc (NASDAQ:REGN).
In the study, upadacitinib showed superior efficacy versus dupilumab in the primary endpoint, demonstrating that a significantly higher proportion of patients simultaneously achieved both a 90% or greater reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16.
- Rinvoq helped 19.9% of patients achieve 90% skin clearance with a no-to-little itch, compared with 8.9% of patients treated with Dupixent.
- The EASI is a clinically validated measure used to assess the severity and extent of atopic dermatitis.
- WP-NRS is an assessment tool that patients use to report the intensity of their pruritus daily (with 0 being 'no itch' and 10 being the 'worst imaginable itch').
Upadacitinib also showed superiority over dupilumab for all ranked secondary endpoints, including the rapid onset of nearly complete skin clearance and little to little itch.
For the first two ranked secondary endpoints, the study showed that a significantly higher proportion of patients treated with upadacitinib:
- Achieved EASI 90 at Week 16 (40.8% vs 22.5%).
- Achieved a WP-NRS of 0/1 at Week 16 (30.2% vs 15.5%).
Price Action: ABBV shares were down 0.15% at $167.54 at the last check Thursday.
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