AbbVie has announced positive topline results from a late-stage maintenance study investigating the use of its interleukin-23 inhibitor in adults with moderately to severely active ulcerative colitis.
The phase 3 COMMAND trial enrolled patients from a phase 2b/3 study of Skyrizi (risankizumab) who had responded to induction treatment. The patients were re-randomised to receive Skyrizi at a dose level of 180mg or 360mg, or withdraw from treatment.
Results showed that 40% of patients treated with Skyrizi 180mg and 38% of those receiving Skyrizi 360mg achieved the study’s primary endpoint of clinical remission at week 52, compared to 25% of patients in the induction-only control group.
Additionally, 51% and 48% of patients treated with Skyrizi 180mg or 360mg, respectively, achieved endoscopic improvement at week 52 versus 32% of patients in the control group, and significantly more patients treated at both dose levels with Skyrizi achieved histologic endoscopic mucosal improvement.
Safety results were consistent with the known safety profile of Skyrizi, AbbVie said, with no new safety risks observed.
Ulcerative colitis is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as persistent diarrhoea and abdominal pain. The condition is one of the two main types of inflammatory bowel disease, which affects nearly one in every 100 people in the US.
The disease course of ulcerative colitis varies between patients and can range from inactive disease to chronic refractory, which in some cases can lead to surgery or life-threatening complications.
Skyrizi, which is part of a collaboration between AbbVie and Boehringer Ingelheim, is already approved in the US and EU to treat certain patients with Crohn’s disease, plaque psoriasis and psoriatic arthritis.
Roopal Thakkar, senior vice president, development, regulatory affairs and chief medical officer at AbbVie, said: “Through important programmes such as the phase 3 COMMAND study, we continue to drive research and development to help manage the impact of serious gastroenterological conditions.
“[Skyrizi] is already approved in moderately to severely active Crohn’s disease, and these results demonstrate that this treatment can be a potentially effective option for ulcerative colitis as well.”