New data shows upadacitinib has efficacy in treating patients with ulcerative colitis.
According to the results of U-ACHIEVE, a phase 3 induction study, 45 mg once daily of the drug resulted in 26% of patients achieving clinical remission, compared to 5% of patients who received the placebo (P <0.001).
In addition, more patients in the treatment arm (36%) achieved endoscopic improvement at week 8 compared to patients receiving placebo (7%) (P <0.001).
The investigators also found 30% of patients in the upadacitinib group achieved endoscopic mucosal improvement at week 8, compared to just 7% of the placebo group (P <0.001).
A greater proportion of patients treated with upadacitinib (73%) achieved clinical response graded using the Adapted Mayo Score at week 8 compared to placebo (27%) (P <0.001), while 60% of patients treated with upadacitinib experienced clinical response at week 2, compared to 27% on placebo (P <0.001).
“Ulcerative colitis is a complex disease to manage, and many patients do not achieve relief from symptoms,” Silvio Danese, MD, lead study investigator and head of the Inflammatory Bowel Diseases Centre at Humanitas Research Hospital, said in a statement. “I am excited about these positive results showing the potential of upadacitinib to alleviate symptoms and control mucosal inflammation in patients with moderate to severe ulcerative colitis.”
The investigators also found the safety profile of upadacitinib was similar to safety findings in previous trials across indications.
The most common adverse events observed in the upadacitinib group were acne, blood creatine phosphokinase increase, and nasopharyngitis.
However, the increases in blood creatine phosphokinase were not serious and did not lead to drug discontinuation.
These patients were generally asymptomatic, with no cases of rhabdomyolysis reported.
In addition, serious adverse events were found in 2.5% of the treatment group and 5.8% of the placebo arm.
The study represents the first of 2 studies evaluating the drug, produced by AbbVie, as a treatment for adults with moderate to severe ulcerative colitis.
“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, AbbVie, said in a statement. “We are encouraged by these results showing upadacitinib’s potential to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis.”