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Positive results from the second phase 3 study of upadacitinib (Rinvoq; AbbVie) showed that it met all primary and secondary end points for the treatment of moderate to severe atopic dermatitis.
The multicenter, double-blind, placebo-controlled Measure Up 2 study evaluated the safety and efficacy of upadacitinib in patients aged ≥12 years with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to receive upadacitinib 15mg (n=276) or 30mg (n=282) orally once daily, or placebo (n=278), followed by either upadacitinib 15mg or 30mg at week 16. The co-primary end points were the proportion of patients achieving at least a 75% improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) at week 16.
Results showed 60% and 73% of patients treated with upadacitinib 15mg and 30mg, respectively, achieved EASI 75 at week 16, compared with 13% in the placebo arm (P <.0001). Moreover, 39% and 52% of patients treated with upadacitinib 15mg and 30mg, respectively, achieved vIGA-AD 0/1 at week 16, compared with 5% in the placebo arm (P <.001).
In addition, a significantly higher proportion of patients treated with upadacitinib had an improvement in Worst Pruritus Numerical Rating Scale ≥4 at week 16 (secondary end point) compared with placebo (42% with the 15mg dose and 60% with the 30mg dose vs 9% with placebo; P <.001).Moreover, clinically meaningful reductions were observed for itch as early as day 2 in patients treated with upadacitinib 30mg (8% vs 1%; P <.001) and as early as day 3 with upadacitinib 15mg (12% vs 3%; P <.001) compared with placebo.
Regarding safety, there were no new safety risks observed with upadacitinib. The most common adverse events were acne, headache, and upper respiratory tract infection. Full study results will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
In June 2020, the Company also announced positive topline data from the phase 3 Measure Up 1 study of upadacitinib for moderate to severe atopic dermatitis.
Rinvoq, a selective and reversible Janus Kinase (JAK) inhibitor, is currently approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
For more information visit abbvie.com.
