COMMAND: Skyrizi outperforms placebo in achieving, maintaining clinical remission in UC
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Key takeaways:
- Patients receiving maintenance risankizumab 180 mg or 360 mg achieved higher rates of clinical remission vs. those on placebo.
- More risankizumab-treated patients achieved endoscopic improvement and remission.
WASHINGTON — Maintenance Skyrizi 180 mg and 360 mg was superior to placebo in achieving clinical remission among patients with moderately to severely active ulcerative colitis who responded to 12-week induction therapy, according to data.
“Risankizumab is a humanized IgG monoclonal antibody that selectively binds to and inhibits the p19 subunit of IL-23,” Stefan Schreiber, MD, director of the Institute of Clinical Molecular Biology at Kiel University and professor of medicine at Christian-Albrechts University in Germany, said at Digestive Disease Week. “The phase 3 induction trial INSPIRE demonstrated that IV risankizumab 1,200 mg treatment was superior to placebo in achieving the primary endpoint of clinical remission and all the secondary endpoints, including clinical and endoscopic outcomes, and was well-tolerated.”
In the phase 3, double-blind, placebo-controlled COMMAND maintenance study, Schreiber and colleagues enrolled 548 patients with active UC who achieved clinical response to IV Skyrizi (risankizumab, AbbVie) after 12 or 24 weeks in the phase 2b and phase 3 INSPIRE induction studies.
Patients were randomly assigned to subcutaneous risankizumab 180 mg (n = 193) or 360 mg (n = 195) or placebo (risankizumab withdrawal; n = 196) every 8 weeks for 52 weeks. The primary efficacy analysis included patients who received at least one dose of study drug after responding to 12 weeks of induction, while the safety analysis included week 12 or week 14 responders.
The primary endpoint was clinical remission at week 52, defined by the adapted Mayo score. Secondary endpoints included endoscopic improvement, histological-endoscopic mucosal improvement (HEMI), endoscopic remission, steroid-free clinical remission and maintenance of clinical remission, as well as absence of bowel urgency and abdominal pain.
At baseline, more than 75% of patients had a history of inadequate response or intolerance to at least one advanced therapy.
Results demonstrated significantly higher rates of clinical remission among patients who received risankizumab 180 mg (40.2%) or 360 mg (37.6%) compared with placebo (25.1%), for an adjusted treatment difference of 16.3% and 14.2%, respectively. In addition, 70.2% and 50% vs. 39.6% of patients maintained clinical remission and 39.6% and 37.1% vs. 25.1% achieved steroid-free clinical remission at week 52.
Further, a greater proportion of treated patients vs. those on placebo achieved key secondary endpoints of endoscopic improvement (50.8% and 48.3% vs. 31.7%), HEMI (42.8% and 42.2% vs. 23.5%) and endoscopic remission (23.2% and 24.3% vs. 14.8%), as well as no bowel urgency (53.6% and 49.4% vs. 31.1%) and no abdominal pain (46.9% and 37.8% vs. 29.5%).
Researchers observed similar rates of adverse events and serious infections between treatment groups. However, serious (10 and 10 vs. 16) and severe (3 and 6 vs. 10) adverse events were lower among patients in the risankizumab groups. There were no new safety risks.
“In patients with moderately to severely active UC responding to 12-week risankizumab IV induction therapy, risankizumab maintenance dosing at both 180 mg and 360 mg subcutaneous was superior to placebo withdrawal treatment in achieving the primary endpoint of clinical remission and key secondary endpoints including clinical, endoscopic, endoscopic-histologic and patient-reported outcomes at week 52,” Schreiber said.
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Schreiber S, et al. Risankizumab maintenance therapy in patients with moderately to severely active ulcerative colitis: Efficacy and safety in the randomized phase 3 COMMAND study. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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