EU approves Rinvoq for atopic dermatitis.
The recommended dose of Rinvoq for atopic dermatitis in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents (12-17 years of age) and adults 65 years and older. Rinvoq can be used with or without topical corticosteroids (TCS).
The EC approval is supported by data from one of the largest registrational Phase III programs in atopic dermatitis with more than 2,500 adults and adolescents with moderate to severe disease. These studies evaluated the efficacy and safety of Rinvoq monotherapy (Measure Up 1 [MU1] and Measure Up 2 [MU2]) and with topical corticosteroids (AD Up [AU]) compared to placebo. In all three studies, the co-primary endpoints were at least a 75 percent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.
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