AbbVie has reported that its Phase III COMMAND study of risankizumab (SKYRIZI) for the treatment of active ulcerative colitis has met the primary endpoint of clinical remission at week 52, and key secondary endpoints.
The double-blind, multicentre, controlled, randomised, maintenance study has evaluated the safety and efficacy of risankizumab 180mg or 360mg administered subcutaneously in adults with moderately to severely active ulcerative colitis.
Patients who responded to risankizumab IV induction in the Phase IIb/III INSPIRE study were re-randomised to receive both dosages.
They were also randomised to the withdrawal from risankizumab treatment (induction-only control group).
Key secondary endpoints including steroid-free remission, histologic endoscopic mucosal improvement, and endoscopic improvement at one year were also met.
The safety profile of risankizumab was consistent with no new safety risks reported in the trial.
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Nasopharyngitis, arthralgia, colitis ulcerative, and Covid-19 are some of the most common adverse events observed in the risankizumab group.
AbbVie chief medical officer and development, regulatory affairs senior vice-president Roopal Thakkar said: “Through important programmes such as the Phase III COMMAND study, we continue to drive research and development to help manage the impact of serious gastroenterological conditions.
“Risankizumab 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.”
Part of a collaboration between AbbVie and Boehringer Ingelheim, risankizumab blocks the p19 subunit of interleukin-23 (IL-23) thereby reducing inflammation.
AbbVie is also evaluating risankizumab in psoriasis, psoriatic arthritis, and Crohn’s disease in Phase III trials.