In the study, Risankizumab achieved the primary endpoint of clinical remission at week 52 and met its key secondary endpoints in adult patients with moderately to severely active ulcerative colitis
AbbVie’s risankizumab shows positive results in Phase 3 trial. (Credit: AbbVie Inc.)
AbbVie has announced that its risankizumab (SKYRIZI) has met primary and key secondary endpoints in a 52-week COMMAND Phase 3 maintenance study in ulcerative colitis patients
Risankizumab is an interleukin-23 (IL-23) inhibitor that targets IL-23 by binding to its p19 subunit.
The positive top-line results from the COMMAND study showed that Risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52.
Risankizumab also achieved its key secondary endpoints in adult patients with moderately to severely active ulcerative colitis.
In the study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomised to get risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab therapy.
AbbVie said that around 75% of patients previously failed at least one advanced therapy for ulcerative colitis.
In addition, a major portion of patients who received 180 mg or 360 mg of IL-23 inhibitor achieved clinical remission at week 52: 40% and 38%, respectively, compared to 25% in the induction-only control group.
AbbVie chief medical officer and regulatory affairs, development SVP Roopal Thakkar said: “Through important programs such as the Phase 3 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.”
In the trial, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with 360 mg of IL-23 inhibitor met endoscopic improvement at week 52 against 32% of patients in the induction-only control group.
Additionally, 43% of patients treated with risankizumab 180 mg and 42% of patients treated with 360 mg achieved histologic endoscopic mucosal improvement at week 52 compared to 23% of patients who were treated with induction only.
The COMMAND study is a Phase 3, multicentre, randomised, double-blind, controlled study designed to evaluate the efficacy and safety of IL-23 inhibitor.
The primary endpoint was defined as clinical remission (per Adapted Mayo Score) at week 52 and Secondary endpoints include endoscopic improvement, HEMI, and steroid-free clinical remission.