New data shows upadacitinib increases rates of clinical remission when compared to placebo in patients with ulcerative colitis.
AbbVie announced the results from the trial testing 45 mg, once daily dosing of upadacitinib, showing the treatment met the primary endpoint of clinical remission, as well as all ranked secondary endpoints, including clinical, endoscopic, and histologic outcomes.
In the phase 3 induction U-ACCOMPLISH trial, 33% of patients in the treatment arm achieved clinical remission as classified by the Adapted Mayor Score at week 8, while only 4% of the placebo group achieved clinical remission (P <0.001).
In addition, 74% of upadacitinib-treated patients experienced a clinical response at week 8 in accordance with the Adapted Mayo Score, while just 25% of placebo-treated patients experienced a clinical response (P <0.001).
The researchers also found 63% of patients in the upadacitinib group achieved clinical response per partial Adapted Mayo Score at week 2 compared 26% of the placebo group (P <0.001).
At week 8, 44% of the upadacitinib group achieved endoscopic improvement compared to just 8% of patients in the placebo group (P <0.001), while 37% of the individuals in the treatment group achieved histologic-endoscopic mucosal improvement at week 8 versus just 6% in the placebo arm (P <0.001).
“People living with moderate to severe ulcerative colitis continue to suffer from the significant burden of this disease,” said Silvio Danese, MD, lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, in a statement. “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.”
The researchers also found the safety profile of upadacitinib was consistent from the findings in previous induction studies for ulcerative colitis, as well as the findings for studies testing the treatment in other indications.
The most common adverse event identified in the U-ACCOMPLISH trial were acne, blood creatine phosphokinase increase, and anemia. However, the increases in blood creatine phosphokinase were deemed non-serious and did not lead to any drug discontinuation.
This adverse event subgroup was generally asymptomatic, with no cases of rhabdomyolysis reported.
In addition, serious adverse events occurred in 3.2% of patients in the upadacitinib group and 4.5% of the patients in the placebo groups.
There were also similar rates of serious infections (0.6%) in both treatment groups.
There were no deaths, gastrointestinal perforation, malignancy, major cardiovascular or thromboembolic events were reported in the upadacitinib group, with 1 case of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and 1 case of gastrointestinal perforation was reported in the placebo group.
The study represents the second of a pair of phase 3 induction studies evaluating the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis. The full results of the study are expected to be presented at a future meeting.
“We remain steadfast in our pursuit of transforming the treatment landscape for people living with ulcerative colitis,” Tom Hudson, senior vice president of research and development, AbbVie, said in a statement. “These positive results confirm the findings of the previous induction study and underscore the potential impact upadacitinib could have on patients struggling to manage their disease.”