AbbVie is seeking approval of upadacitinib (Rinvoq™), a selective and reversible Janus Kinase (JAK) inhibitor, for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
The regulatory application is supported by data from 3 randomized, double-blind, placebo-controlled phase 3 studies (Measure Up 1, Measure Up 2, AD Up) that assessed the efficacy and safety of upadacitinib in patients aged 12 years and older with moderate to severe atopic dermatitis who are candidates for systemic therapy. Upadacitinib was investigated without topical corticosteroids (TCS) in the Measure Up 1 and Measure Up 2 trials, and with TCS in the AD Up study.
The co-primary end points for all 3 studies 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. Findings showed that the trials met the co-primary and all secondary end points in adult and adolescent patients. Upadacitinib was associated with significant improvements in skin clearance and itch reduction compared with placebo.
Rinvoq 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.
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AbbVie submits regulatory applications to FDA and EMA for Rinvoq™ (upadacitinib) in atopic dermatitis. [press release]. North Chicago, IL: AbbVie; October 19, 2020.
This article originally appeared on MPR