Benzinga - by Vandana Singh, Benzinga Editor.
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’).
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%).
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