Upadacitinib meets all endpoints in Phase III ulcerative colitis trial

According to AbbVie, upadacitinib (RINVOQ™) met all its primary endpoint of clinical remission and all ranked secondary endpoints in the Phase III induction study, U-ACCOMPLISH. In the trial, a third of ulcerative colitis patients receiving upadacitinib achieved clinical remission (per Adapted Mayo Score) at week eight, compared to four percent of patients receiving placebo.

U-ACCOMPLISH (NCT03653026) is a Phase III multi-centre, randomised, double-blind, placebo-controlled induction study to evaluate the efficacy and safety of upadacitinib 45mg taken once daily compared to placebo in adult subjects with moderate to severe ulcerative colitis. U-ACCOMPLISH is the second Phase III induction study to evaluate the safety and efficacy of upadacitinib in this indication.

In the trial, 74 percent of upadacitinib-treated patients experiencing clinical response at week eight versus 25 percent of patients receiving placebo. Additionally, 63 percent of patients treated with upadacitinib achieved clinical response at week two versus 26 percent of those receiving placebo.

At week eight, 44 percent of patients treated with upadacitinib achieved endoscopic improvement versus eight percent of those on placebo. Moreover, significantly more upadacitinib-treated patients achieved histologic-endoscopic mucosal improvement at week eight compared to patients receiving placebo (37 versus six percent).

The safety profile of upadacitinib was consistent with the safety findings in the previously reported, 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 anaemia. 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.

Full results from the U-ACCOMPLISH study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.

“People living with moderate to severe ulcerative colitis continue to suffer from the significant burden of this disease,” commented Dr Silvio Danese, lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, Milan, Italy. “I am very impressed with the consistent results seen in both ulcerative colitis induction studies, suggesting that upadacitinib could be a potential new treatment option for patients.”