Phase III Measure Up 1 and Measure Up 2 studies support applications to FDA and MAA for Rinvoq in atopic dermatitis.- AbbVie

Late-breaking data analyses will be presented by AbbVie showing that significantly more atopic dermatitis patients treated with Rinvoq (upadacitinib) (15 mg or 30 mg; once daily) monotherapy achieved improvement in additional measures of skin clearance and reduction in itch compared to placebo. These data are from the Phase III Measure Up 1 and Measure Up 2 studies, which support the recent applications to the FDA and EMA, seeking approval for Rinvoq in adult and adolescent patients with moderate to severe atopic dermatitis. In both of the Measure Up 1 and 2 studies, significantly more patients treated with either dose of upadacitinib achieved at least a 90 percent improvement in the Eczema Area Severity Index (EASI 90) compared to patients treated with placebo at week 16 (53/66 percent of patients receiving upadacitinib 15/30 mg versus 8 percent receiving placebo in Measure Up 1; 42/58 percent of patients receiving upadacitinib 15/30 mg versus 5 percent receiving placebo in Measure Up 2) [p<0.001]). additionally, for both doses of upadacitinib, the proportion of patients achieving a clinically meaningful itch reduction was significantly higher than placebo at week 4 and maintained through week 16. a clinically meaningful itch reduction was defined as improvement in worst pruritus numerical rating scale (nrs)at least 4.1. data were presented at the 29th european academy of dermatology and venereology (eadv) virtual congress. the applications which were announced on 19 october 2020, are supported by data from three pivotal phase iii studies. rinvoq was studied without topical corticosteroids (tcs) in measure up 1 and measure up 2 and with tcs in ad up.>