Risankizumab Improves Ulcerative Colitis Symptoms in Phase 3 Induction Study

In adults with moderately to severely active ulcerative colitis, treatment with risankizumab resulted in clinical remission and an improvement in symptoms, according to findings from the phase 3 INSPIRE induction study.

The multicenter, randomized, double-blind, placebo-controlled INSPIRE study (ClinicalTrials.gov Identifier: NCT03398148) included 975 patients with moderately to severely active ulcerative colitis who demonstrated intolerance or inadequate response to conventional therapies and/or advanced therapies (biologics, Janus kinase inhibitors, and S1P receptor modulators). Patients were randomly assigned 2:1 to receive either risankizumab 1200mg intravenously (IV) every 4 weeks as induction therapy (n=650) or placebo (n=325). 

The primary endpoint was clinical remission per adapted Mayo Score, defined as stool frequency subscore of no more than 1 and not greater than baseline, rectal bleeding subscore of 0 and endoscopic subscore of no more than 1 without friability at week 12. 

Results showed that 20.3% of patients treated with risankizumab achieved clinical remission at week 12 compared with 6.2% of patients who received placebo (P <.00001). Moreover, 36.5% of risankizumab-treated patients achieved endoscopic improvement at week 12 compared with 12.1% of patients on placebo (P <.00001).

Findings also showed a greater percentage of patients in the risankizumab treatment arm achieved histologic-endoscopic mucosal improvement (24.5% vs 7.7%; P <.00001) and clinical response (64.3% vs 35.7%) at week 12 compared with placebo.

The safety profile of risankizumab was consistent with that observed in previous studies across other indications. The most common adverse reactions reported were COVID-19, anemia, and arthralgia. 

“It is impressive to see the meaningful responses that were achieved in the INSPIRE study, which demonstrates the potential of risankizumab to serve as an option across inflammatory bowel diseases,” said Edouard Louis, MD, PhD, professor and head of the department of gastroenterology, University Hospital CHU of Liège Belgium, INSPIRE study investigator. “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence.”

AbbVie is currently investigating risankizumab for the maintenance treatment of ulcerative colitis among patients who responded to induction treatment in the INSPIRE study.

Risankizumab, an interleukin-23 inhibitor, is currently marketed under the brand name Skyrizi^® for the treatment of active psoriatic arthritis, moderately to severely active Crohn disease, and moderate to severe plaque psoriasis.