Phase III U-ACCOMPLISH study of Rinvoq meets primary endpoint in ulcerative colitus.- AbbVie

AbbVie announced that Rinvoq (upadacitinib 45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints in the Phase III induction study, U-ACCOMPLISH in adults with moderate to severe ulcerative colitis. In the study, 33 percent of patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week 8 compared to 4 percent of patients receiving placebo (p<0.001). u-accomplish is the second of two phase iii induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis. in this study, all ranked secondary endpoints were met, including clinical, endoscopic and histologic outcomes. a greater proportion of patients treated with upadacitinib achieved clinical response compared to placebo, with 74 percent of upadacitinib-treated patients experiencing clinical response (per adapted mayo score) at week 8 versus 25 percent of patients receiving placebo (p><0.001). additionally, 63 percent of patients treated with upadacitinib achieved clinical response (per partial adapted mayo score) at week 2 versus 26 percent of those receiving placebo (p><0.001). at week 8, 44 percent of patients treated with upadacitinib achieved endoscopic improvement versus 8 percent of patients receiving placebo (p><0.001). and significantly more upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week 8 compared to patients receiving placebo (37 percent versus 6 percent; p><0.001). the safety profile of upadacitinib (45 mg) was consistent with the safety findings in the previously reported phase iii induction study in ulcerative colitis and safety findings in previous studies across indications, with no new safety risks observed. during the 8-week study period, the most common adverse events observed in the upadacitinib group were acne, blood creatine phosphokinase increase and anemia. the increases in blood creatine phosphokinase were non-serious and did not lead to study drug discontinuation. patients with blood creatine phosphokinase increase were usually asymptomatic and no cases of rhabdomyolysis were reported. serious adverse events occurred in 3.2 percent of patients in the upadacitinib group and 4.5 percent of patients in the placebo group. similar rates of serious infections (0.6 percent) were observed in the two treatment groups. no deaths, gastrointestinal perforation, malignancy, major cardiovascular or thromboembolic events were reported in the upadacitinib group. one case of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and one case of gastrointestinal perforation was reported in the placebo group. full results from the u-accomplish study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. top-line results from the phase iii portion of the first induction study, u-achieve, were announced in december 2020 and the maintenance study for both is ongoing.>