AbbVie’s Dermatitis Drug Proven ‘Superior’ to Sanofi/Regeneron’s Dupixent in Head-to-Head Study – Regeneron Pharmaceuticals (NASDAQ:REGN), AbbVie (NYSE:ABBV)

Thursday, AbbVie Inc ABBV published key results from LEVEL UP, an efficacy-evaluator-blinded, open-label, comparative phase 3b/4 study of upadacitinib (Rinvoq, starting dose of 15 mg once daily and dose adjusted based on clinical response) compared to dupilumab (Dupixent, according to the dose indicated on the label) for atopic dermatitis.

AbbVie said the study is the first head-to-head comparison in atopic dermatitis evaluating upadacitinib at a starting dose of 15 mg daily versus dupilumab at the indicated dose.

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The study enrolled adults and adolescents with moderate to severe atopic dermatitis (AD) who had had an inadequate response to systemic therapy or when the use of such therapies was inadvisable.

Dupixent is the flagship drug of Sanofì SA CUT AND Regeneration Pharmaceutical Inc TO RAIN.

In the study, upadacitinib showed superior efficacy compared to dupilumab in the primary endpoint, demonstrating that a significantly higher percentage of patients simultaneously achieved both a 90% or greater reduction in Eczema Area and Severity Index (EASI 90) is a numerical rating scale of worst itching equal to 0 or 1 (WP-NRS 0/1) at week 16.

• Rinvoq helped 19.9% ​​of patients achieve 90% skin clearance with no to mild itching, compared to 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 itching on a daily basis (where 0 means “no itching” and 10 means “worst imaginable itching”).

Upadacitinib also showed superiority over dupilumab for all graded secondary endpoints, including rapid onset of near-complete skin clearance and mild to mild pruritus.

For the top two ranked secondary endpoints, the study demonstrated that a significantly higher percentage of patients treated with upadacitinib:

• Reached 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: At last check, ABBV shares were down 0.15% at $167.54.

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