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AbbVie to Present New Analyses from Pivotal Phase 3 Studies for RINVOQa?? (upadacitinib) in Atopic Dermatitis

NORTH CHICAGO, Ill., Oct. 29, 2020 /PRNewswire/ --A Late-breaking data analyses to be presented by AbbVie (NYSE: ABBV) at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress show that significantly more atopic dermatitis patients treated with upadacitinib (15 mgA or 30 mg; once daily) monotherapy achieved improvement in additional measures of skin clearance and reduction in itch compared to placebo.1 These data are from the Phase 3 Measure Up 1 and Measure Up 2 studies, which support the recent applications to the U.S. Food and Drug Administration and European Medicines Agency, seeking approval for RINVOQ in adult and adolescent patients with moderate to severe atopic dermatitis.In both of theA 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]).1 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 16.1 A clinically meaningful itch reduction was defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)a??4.1"I'm encouraged to see results showing a high proportion of patients treated with upadacitinib achieved EASI 90, or almost clear skin, and significant reduction in their itch," said lead investigator Emma Guttman-Yassky, M.D., Ph.D., professor of dermatology and immunology, director of the center for excellence in eczema and laboratory for inflammatory skin diseases and the incoming chair of the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York.* "The speed and degree of response with upadacitinib are meaningful to patients, many of whom suffer from substantial burden of disease that can interfere with daily life."Earlier this year, AbbVie announced top-line data from Measure Up 1 and Measure Up 2 showing upadacitinib (15 mg or 30 mg) met the co-primary endpoints of EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1At EADV, AbbVie will also present new analyses showing significantly more patients reported improvements in quality of life as measured by a Dermatology Life Quality Index (DLQI) score of 0/1 after 16 weeks of treatment with either dose of upadacitinib, compared to those on placebo.1 DLQI is a measure of a patient's health-related quality of life, ranging from 0 to 30, with a score of 0 or 1 indicating the disease no longer had an impact on their quality of life.5
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