Risankizumab Effective Treating Moderate-to-Severe Crohn’s Disease

Patients in both the ADVANCE and MOTIVATE studies achieved enhanced clinical response and endoscopic response.

In new data presented at the 2021 American College of Gastroenterology (ACG) Annual Meeting, investigators found risankizumab resulted in a greater proportion endoscopic response than placebo for patients with Crohn’s disease.

A team, led by Edward V. Loftus, MD, FACG, Mayo Clinic, assessed different endoscopic endpoints in patients treated with Risankizumab induction therapy in the ADVANCE and MOTIVATE clinical trials.

Endoscopic healing is now a critical treatment target for patients with Crohn’s disease.

The Drug

Risankizumab is a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin 23 that is being targeted for the treatment of patients with moderate-to-severe Crohn’s disease.

In the double-blind, randomized, placebo-controlled studies, the investigators examined patients with moderate-to-severe Crohn’s disease, which was designated as a CD Activity Index (CDAI) of 220-450, Simple Endoscopic Score for CD of at least 6, excluding the narrowing component, and average daily stool frequency of at least 4 and/or an average daily abdominal pain score of at least 2.

The patients also demonstrated prior inadequate response or intolerance to conventional and/or biologic treatment in the ADVANCE study or to biologic treatment in the MOTIVATE trial. The patients were randomized 2:2:1 in the ADVANCE study (n = 850) and 1:1:1 in the MOTIVATE study (n = 569) to receive either intravenous Risankizumab 600 mg, 1200 mg risankziumab, or placebo at weeks 0, 4, and 8.

The New Analysis

In the new assessment, the investigators evaluated the proportion of patients who achieved endoscopic remission ulcer-free endoscopy and composite endpoints of CDAI clinical response and endoscopic response, as well as enhanced clinical response and endoscopic response at week 12.

There was a greater proportion of patients in both studies who achieved endoscopic remission (P ≤.001), ulcer-free endoscopy (P ≤.001), CDAI clinical response and endoscopic response (P ≤.001) and enhanced clinical response and endoscopic response (P ≤.001) at week 12.

Either dosing of the drug was well-tolerated, with no new safety risk identified.

“Induction therapy with IV [Risankizumab] 600 mg or 1200 mg resulted in improved outcomes at week 12 compared with [placebo] as assessed by endoscopy and by composite endoscopic-clinical endpoints in patients with moderate-to-severe [Crohn’s disease],” the authors wrote.

The study, “Risankizumab Therapy Induces Improvements in Endoscopic Endpoints in Patients With Moderate-To-Severe Crohn’s Disease: Results From the Phase 3 ADVANCE and MOTIVATE Studies,” was published online by ACG.