Remo Panaccione, MD: Risankizumab Maintenance Therapy Efficacy, Dosing for Ulcerative Colitis

Risankizumab maintenance therapy is efficacious for the treatment of moderately to severely active ulcerative colitis (UC) regardless of clinical remission or endoscopic improvement status after 12 weeks of induction, according to findings from a post hoc analysis of the phase 3 COMMAND study.

Results were presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, by Remo Panaccione, MD, director of the inflammatory bowel disease unit at the University of Calgary, and showed the rates of each clinical, endoscopic, and histologic outcome in COMMAND were generally numerically higher with risankizumab versus placebo at maintenance week 52 regardless of clinical remission or endoscopic improvement status.

An anti-interleukin (IL)-23 monoclonal antibody targeting p19, risankizumab was approved by the FDA for the treatment of moderately to severely active UC on June 18, 2024, making it the first IL-23 specific inhibitor approved for both moderate to severe UC and moderate to severe Crohn’s disease (CD). FDA-approved dosing of risankizumab-rzaa for UC includes a 12-week induction period with 3 1200 mg doses delivered every 4 weeks followed by maintenance therapy of either 180 mg or 360 mg delivered every 8 weeks.

The post hoc analysis presented at ACG evaluated clinical, endoscopic, and histological outcomes through 52 weeks of maintenance by clinical remission or endoscopic improvement status after 12 weeks of induction in COMMAND, 1 of 2 phase 3 studies used to support risankizumab’s FDA approval for UC. Results showed that among overall induction responders with clinical remission or endoscopic improvement at maintenance week 0, more patients treated with risankizumab achieved endoscopic improvement, endoscopic remission, or histological-endoscopic mucosal healing at week 52.

Specifically, among risankizumab 1200 mg induction responders with clinical remission at maintenance week 0, more patients treated with risankizumab 180 mg and risankizumab 360 mg versus placebo achieved endoscopic improvement (80.5% and 66.7% vs 46.7%), endoscopic remission (55.1% and 33.3% vs 23.3%), or histological-endoscopic mucosal healing (72.3% and 66.7% vs 40.0%) at week 52. Additionally, induction responders with endoscopic improvement at maintenance week 0 achieved endoscopic improvement (74.8% and 59.4% vs 51.2%), endoscopic remission (48.1% and 36.8% vs 23.3%), or histological-endoscopic mucosal healing (68.9% and 56.6% vs 39.5%) at week 52.

Of note, the rates of each outcome were greater with risankizumab 360 mg than with risankizumab 180 mg in pts with inadequate disease activity at maintenance week 0.

“We saw numerically higher rates using the 360 in those patients that didn't achieve clinical remission or endoscopic improvement, so if you don't get that really robust response when you're going to maintenance, you should use the 360 instead of the 180,” Panaccione explained to HCPLive.

Editors’ note: Panaccione has relevant disclosures with Abbott, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Janssen, Lilly, Novartis, Takeda, and others.

References

1. ^{Panaccione R, Bossuyt P, Blumenstein I, et al. P4377 - Efficacy of Risankizumab Maintenance Therapy by Clinical Remission and Endoscopic Improvement Status in Patients With Moderately to Severely Active Ulcerative Colitis: Post Hoc Analysis of the COMMAND Phase 3 Study. Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}
2. ^{Brooks, A. FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis. HCPLive. June 18, 2024. Accessed October 31, 2024. https://www.hcplive.com/view/fda-approves-risankizumab-skyrizi-for-ulcerative-colitis}