The most valuable anti-inflammatory drug in the study! AbbVie upadacitinib treats ulcerative colitis (UC) significantly induced clinically:

U.S. biotech giant AbbVie recently announced positive results of the new anti-inflammatory drug JAK1 selective inhibitor upadacitinib to treat ulcerative colitis (UC) in phase IIb/III clinical study U-ACHIEVE (NCT02819635) at the European Digestive Disease Week (UEG) in Vienna, Austria. Data show that after 8 weeks of treatment, the upadacitinib high-dose group reached the primary endpoint and all secondary endpoints.
the study is an ongoing multi-center, randomized, double-blind, placebo-controlled study conducted in adult patients with moderate to severe active UC to assess the efficacy and safety of upadacitinib in inducing and maintaining treatment. The purpose of the IIb part of the study was to determine the dose-response, efficacy and safety of upadacitinib induced clinical remission compared to placebo, and to determine the induced dose of upadacitinib for further evaluation in The Phase III study. In the study, patients in the group who did not respond well to corticosteroids, immunosuppressants or biotherapy, lost their reactions, or were not todded, were randomly assigned a placebo and upadacitinib treatment of 7.5 mg, 15 mg, 30 mg, 45 mg once a day for 8 weeks. The main endpoint of the IIb period is the proportion of patients who have reached clinical remission at week 8 (defined as stool frequency sub-item (SFS)≤1, rectal hemorrhage single item (RBS) s0, endoscopic single item (ES≤1). Secondary endpoints included week 8 mirror improvement (ES≤1), clinical remission (Full Mayo score ≤2 points, and no single score >1), clinical response (Adapted Mayo score decreased by >2 points and >30% compared to baseline), and RBS decreased by >1 or RBS absolute value <1).
results showed that in the 8th week of treatment, a higher proportion of patients in the upadacitinib high-dose group (15 mg, 30 mg, 45 mg) achieved clinical remission than in the placebo group (14 percent, 14 percent, 20 percent, respectively). In addition, the upadacitinib high-dose group (15 mg, 30 mg, 45 mg) reached critical secondary endpoints, including endoscopic improvement, clinical remission, and clinical response. The upadacitinib 7.5 mg dose group did not reach the main endpoint. The safety profile observed in this study is consistent with the Phase II Crohn's disease study and no new safety signals were found.
the conference also presented two independent analyses from the U-ACHIEVE study. One of the analyses showed that patients treated with upadacitinib showed greater relief in UC symptoms, including urgency in the intestines, abdominal pain, rectal bleeding, and stool frequency, compared to placebo. Another analysis showed significant and clinically significant improvements in patients treated with upadacitinib in terms of disease specificity and general health-related quality of life, fatigue, productivity, and ability to perform daily activities after 8 weeks of treatment compared to placebos.
, lead researcher on the U-ACHIEVE study, a professor of medicine at the University of California and director of the Center for Inflammatory Bowel Disease in Gastroenterology, said UC is a difficult-to-treat disease with symptoms and significant impact on patients' daily lives. The U-ACHIEVE study included incurable UC patients, most of whom had previously failed in a variety of therapies, including biotherapy. The results of this study further expand our understanding of the potential of upadacitinib as an important treatment option for UC patients.
upadacitinib is an experimental oral selective JAK1 inhibitor, JAK1 is a kinase that plays a key role in the pathophysiology of a variety of inflammatory diseases, including UC. In addition to UC, AbbVie is currently investigating the efficacy and safety of upadacitinib's treatment of rheumatoid arthritis (RA) and psoriasis arthritis (PsA) in Phase III clinical studies. In addition, the company is also investigating the potential of upadacitinib to treat Crohn's disease (CD) and adiopathic dermatitis and severe spina bnea.
pharmaceutical market research agency, Evaluate Pharma, reported in June that upadacitinib was a highly valuable drug under study, ranking second on the TOP20 list of drugs under study and would have global sales of $2.57 billion in 2024 if it went on the market. (Bio Valley)