Wow.
prnewswire.com
NORTH CHICAGO, Ill., Sept. 7, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 2b randomized, placebo-controlled, dose-ranging study of upadacitinib (ABT-494), an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.1 In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo).1 Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.
"We are excited by the results of this study, which show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to advancing upadacitinib to Phase 3 studies in 2018. AbbVie's continued progress across our upadacitinib clinical development program further demonstrates that selective inhibition of the JAK1 pathway may be a novel therapeutic approach across a broad range of immune-mediated diseases."
Results at week 16 showed that across all doses, the primary and all skin and itch-specific secondary endpoints, patients treated with upadacitinib achieved improvements that were statistically significant compared to placebo (p<0.05).1 Additionally, reduction in itch was observed within the first week and improvement in skin within the first two weeks (p<0.001 across all doses). |
