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Topline results from a phase 3 study evaluating upadacitinib monotherapy in patients aged ≥12 years with moderate to severe atopic dermatitis (AD) showed the treatment was associated with significant improvement in skin clearance.
In the double-blind, placebo-controlled MEASURE UP 1 study, 847 patients aged ≥12 years with moderate to severe AD who are candidates for systemic therapy were randomized to receive upadacitinib 15mg (n=281) or 30mg (n=281) orally once daily, or placebo (n=285), followed by either upadacitinib 15mg or 30mg at week 16. The co-primary endpoints 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 70% of patients treated with upadacitinib 15mg and 80% of patients treated with the 30mg dose achieved EASI 75 at week 16, compared with 16% in the placebo arm (P <.001). Additionally, 48% and 62% of patients treated with upadacitinib 15mg and 30mg, respectively, achieved vIGA-AD 0/1, respectively, compared with 8% in the placebo arm (P <.001).
Moreover, 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 (52% with the 15mg dose and 60% with the 30mg dose vs 12% with placebo; P <.001). Patients also experienced clinically meaningful reductions in itch as early as day 2 in the 30mg arm (12% vs 4%; P <.001) and day 3 in the 15mg arm (16% vs 3%; P <.001) compared with placebo.
With regard to safety, there were no new safety risks observed with upadacitinib. The most common treatment-emergent adverse events were acne, upper respiratory tract infection and nasopharyngitis. Full study results will be presented at a future medical meeting and published in a peer-reviewed publication.
Upadacitinib, a selective and reversible Janus Kinase (JAK) inhibitor, is currently marketed under the brand name Rinvoq™ and is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
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