AbbVie reports 'positive' data from Phase 2b/3 study of upadacitinib
AbbVie announced positive results from U-ACHIEVE, an ongoing Phase 2b/3 dose-ranging study evaluating upadacitinib, an investigational JAK1-selective inhibitor, for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis. After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission and all ranked secondary endpoints. These clinical data, in addition to patient-reported outcomes data from the study, are being presented at United European Gastroenterology Week 2018 in Vienna, Austria. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established. The study showed that significantly more patients achieved clinical remission with upadacitinib (14/14/20 percent of patients in the 15/30/45 mg groups) compared to placebo (0 percent) at week 8.1 Additionally, key secondary endpoints were also achieved at week 8 across the upadacitinib 15/30/45 mg groups, including endoscopic improvement, clinical remission and clinical response. The upadacitinib 7.5 mg group did not meet the primary endpoint. These results are being presented October 22 during an oral presentation entitled "Efficacy and safety of upadacitinib as an induction therapy for patients with moderately to severely active ulcerative colitis: data from the phase 2b study U-ACHIEVE" from 2:12 - 2:24 p.m. CEST.