AbbVie’s JAK inhibitor Rinvoq met the primary and all secondary endpoints in a Phase III ulcerative colitis maintenance study, the company announced earlier this week.
The ongoing maintenance study is evaluating the efficacy and safety of once-daily Rinvoq (upadacitinib) 15 mg and 30 mg in patients with moderate-to-severe ulcerative colitis.
According to AbbVie, a significantly higher proportion of Rinvoq-treated patients achieved clinical remission at week 52 compared to placebo – the primary study endpoint.
Patients who achieved a clinical response following an eight-week study period of once-daily Rinvoq induction treatment were re-randomised to receive Rinvoq 15 mg, Rivoq 30 mg or placebo for an additional 52 weeks.
In addition to hitting the primary endpoint, all secondary endpoints were also met. This included the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement and corticosteroid-free clinical remission at week 52.
The most common adverse events reported in the Rinvoq groups during the 52-week study period were nasopharyngitis, exacerbation of ulcerative colitis and blood creatine phosphokinase increase.
“Ulcerative colitis is a disease with unpredictable symptoms and frequent flares, which can make daily life challenging,” said Michael Severino, vice chairman and president, AbbVie.
“We are encouraged by these results that demonstrate Rinvoq’s potential as a treatment option for patients with moderate to severe ulcerative colitis,” he added.
The full detailed results from the maintenance study will be presented at a future medical meeting, AbbVie said in a statement.