Rinvoq Found Safe, Effective for Ulcerative Colitis in Ongoing Phase 3 Trial

Rinvoq Found Safe, Effective for Ulcerative Colitis in Ongoing Phase 3 Trial
Rinvoq (upadacitinib), AbbVie's investigational anti-inflammatory medicine, was found to be safe and effective in treating adults with moderate-to-severe ulcerative colitis (UC). The medication met all major endpoints in an ongoing Phase 3 trial (NCT02819635), called U-ACHIEVE, with 26% of patients achieving complete clinical remission after treatment, compared to 5% of those in the placebo group. "Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve disease control," Michael Severino, MD, vice chairman and president of AbbVie, said in a press release. "We are encouraged by these results showing upadacitinib's potential to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis," he said. Rinvoq is an oral anti-inflammatory medication that reduces autoimmune and other pro-inflammatory responses by blocking a family of signaling molecules called JAK proteins. The therapy has been approved as a treatment for rheumatoid arthritis and is now being investigated for UC and Crohn's disease. The U-ACHIEVE trial, which is still recruiting participants, compares Rinvoq's safety and efficacy to placebo in participants, 16 to 75 years old, who have experienced UC for at least 90 days before entering the study. The proportion of patients achieving clinical remission by week eight is the trial's main goal, or primary endpoint. Secondary endpoints include: clinical response, specifically a decrease in Adapted Mayo score, which assesses the severity of UC, of at least two points and 30% or more from baseline (start of the study); endoscopic improvement and histologic-endoscopic mucosal improvement — a reduction in inflammation of the intestine's mucus membrane
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