Risankizumab Therapy for Patients With Moderate to Severe Crohn Disease and Previous Biologic Treatment Failure

Investigators assessed the safety and efficacy of risankizumab therapy in patients with moderately to severely active Crohn disease.

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Risankizumab therapy was more effective than placebo at treating patients with moderately to severely active Crohn disease (CD). These findings were presented during the American College of Gastroenterology (ACG) 2021 Annual Meeting, held from October 22 to 27, 2021, in Las Vegas, Nevada and virtually.

The MOTIVATE study (ClinicalTrials.gov Identifier: NCT03104413), a double-blind, randomized, phase 3 trial recruited patients (N=569) with moderate to severe CD. Patients were randomly assigned, stratified by number of previous biologic treatment failures, in a 1:1:1 ratio to receive 600 mg (n=191) and 1200 mg (n=191) of intravenous risankizumab or placebo (n=187) for 12 weeks. Clinical outcomes and safety were assessed.

Patients had reported 1 failed biologic treatment (n=268) or >1 failed biologic treatment (n=301).

At 18 weeks, 42.5% of the low- and 40.3% of the high-dose risankizumab recipients achieved Clinical Disease Activity Index (CDAI) clinical remission compared with 19.8% of the placebo recipients (both P £.001) and 34.6%, 39.3%, and 19.3% (both P £.001) achieved stool frequency and abdominal pain score (SF/APS) clinical remission, respectively.

Stratified by treatment failures, patients with 1 previous failure were more likely to achieve CDAI clinical remission (46.7% vs 46.6% vs 20.5%) and SF/APS clinical remission (40.2% vs 42.0% vs 21.6%), compared with >1 previous failure (CDAI: 38.5% vs 35.0% vs 19.2%; SF/APS: 29.3% vs 36.9% vs 17.2%) for the low-dose, high-dose, and placebo recipients, respectively.

Similar patters were observed for endoscopic response, in which 28.8% of the low-dose, 34.2% of the high-dose, and 11.2% of the placebo recipients (both P £.001) achieved an endoscopic response. Patients who had more treatment failures exhibited lower response rates among the low-dose (22.2% vs 36.0%), high-dose (25.5% vs 44.3%), and placebo (7.1% vs 15.9%) cohorts, respectively.

Treatment-emergent adverse events were reported by 47.1% of the low-dose, 59.0% of the high-dose, and 66.2% of the placebo recipients. Discontinuation due to adverse events occurred among 1.0% of the low-dose, 2.4% of the high-dose, and 8.2% of the placebo cohorts.

This study was limited by its short study duration. These findings should be confirmed in a longer-term study.

The study authors concluded that intravenous risankizumab was more effective than placebo at treating moderate to severe CD and had a more favorable safety profile.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Panaccione R, Schreiber S, Peyrin-Biroulet L, et al. Risankizumab as induction therapy in patients with moderately to severely active Crohn’s disease who failed 1 vs >1 prior biologic treatment: results from the MOTIVATE study. Presented at: ACG 2021 Annual Meeting; October 22-27, 2021; Las Vegas, NV and virtual. Abstract P0558.