Skyrizi bests placebo in clinical remission as induction, maintenance therapy for UC
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Key takeaways:
- Significant improvements in clinical remission rates were observed at 12 weeks with risankizumab vs. placebo (20.3% vs. 6.2%).
- Improvements were also observed at week 52 (40.2% and 37.6% vs. 25.1%).
Skyrizi significantly improved clinical remission rates as both induction and maintenance therapy vs. placebo in patients with moderately to severely active ulcerative colitis, according to data from the phase 3 INSPIRE and COMMAND trials.
“Risankizumab is a monoclonal IgG-1 antibody that selectively targets the IL-23 p19 subunit, blocking signaling through the IL-23 receptor,” Edouard Louis, MD, of the department of hepato-gastroenterology and digestive oncology at University Hospital CHU of Liege, and colleagues wrote in JAMA. “Risankizumab has been approved by the U.S. FDA and the European Medicines Agency for the treatment of Crohn’s disease, plaque psoriasis and psoriatic arthritis; has been approved by the Pharmaceuticals and Medical Devices Agency for the treatment of palmoplantar pustulosis; and is being investigated for the treatment of ulcerative colitis.”
To determine whether Skyrizi (risankizumab, AbbVie) is more effective than placebo when given as induction and maintenance therapy for patients with moderately to severely active UC, Louis and colleagues evaluated data from the multicenter, double-blind, placebo-controlled INSPIRE and COMMAND trials.
In the INSPIRE induction trial, researchers enrolled 975 patients with UC (mean age, 42.1 years; 60.1% men; 69.6% white), who were randomly assigned 2:1 to receive IV risankizumab 1,200 mg (n = 650) or placebo (n = 325) at weeks 0, 4 and 8.
Those who demonstrated “adequate clinical response” at 12 weeks (n = 548; mean age, 40.9 years; 57.1% men; 74.3% white) continued to the COMMAND maintenance trial and were randomly assigned 1:1:1 to receive subcutaneous risankizumab 180 mg (n = 193) or 360 mg (n = 195) or placebo (n = 196) every 8 weeks for 52 weeks.
The primary outcome was clinical remission, defined as having a stool frequency score of 1 or less and not greater than baseline, a rectal bleeding score of 0 and an endoscopic subscore of no more than 1 without friability. Outcomes were assessed at week 12 for the induction trial and at week 52 for the maintenance trial.
According to INSPIRE results, risankizumab 1,200 mg significantly improved rates of clinical remission compared with placebo (20.3% vs. 6.2%), with an adjusted between-group difference of 14% (95% CI, 10-18).
Using the adapted Mayo score, researchers confirmed significant improvements in clinical response with risankizumab vs. placebo (64.3% vs. 35.7%), as well as in endoscopic improvement (36.5% vs. 12.1%) and remission (10.6% vs. 3.4%). Researchers also reported histological, endoscopic and mucosal improvement (24.5% vs. 7.7%) and remission (6.3% vs. 0.6%).
Results of the COMMAND trial showed clinical remission rates also significantly improved with risankizumab 180 mg and 360 mg vs. placebo (40.2% and 37.6% vs. 25.1%), with adjusted between-groups differences of 16.3% (97.5% CI, 6.1-26.6) and 14.2% (97.5% CI, 4-24.5), respectively.
Both doses significantly improved clinical response vs. placebo (68.2% and 62.3% vs. 51.9%), with between-group differences of 17.1% (97.5% CI, 6.2-28) and 11.5% (97.5% CI, 0.3-22.6), respectively. In addition, risankizumab doses outperformed placebo in endoscopic improvement (50.8% and 48.3% vs. 31.7%), endoscopic remission (23.2% and 24.3% vs. 14.8%) and histological, endoscopic and mucosal improvement (42.8% and 42.2% vs. 23.5%).
The researchers reported no adverse event signals among treatment groups.
“Compared with placebo, risankizumab improved clinical remission rates in an induction trial and in a maintenance trial for patients with moderately to severely active ulcerative colitis,” Louis and colleagues wrote. “Further study is needed to identify benefits beyond the 52-week follow-up.”
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