Benefit of Risankizumab Varies by Location of Crohn’s Disease

February 18, 2022
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

The efficacy rates at weeks 12 and 52 were numerically lower in ileal only Crohn’s disease relative to colonic only and ileal-colonic.

While risankizumab was beneficial for the majority of patients with Crohn’s disease, the benefit varies based on the location of the disease.

A team, led by Peter Bossuyt, MD, PhD, Imelda General Hospital, Gastroenterology, analyzed the efficacy of risankizumab by disease location in data presented during the 2022 European Crohn’s and Colitis Organisation (ECCO) annual meeting.

The disease location can determine the best course of treatment for patients with Crohn’s disease.

Analyzing the Data

In the post-hoc analysis, the investigators reviewed data on patients with moderately to severely active Crohn’s disease and intolerance or inadequate response to convention and/or biologic therapy from the ADVANCE study or to biologic therapy from the MOTIVATE study.

The investigators examined patients who received intravenous risankizumab induction therapy or placebo for 12 weeks. Then any patient achieving clinical response to risankizumab was re-randomized into the FORTIFY maintenance study to receive subcutaneous Risankizumab or subcutaneous placebo for 52 weeks.

The post hoc analysis included patients who received risankizumab 600 mg IV in either the ADVANCE or MOTIVATE and patients who received risankizumab 360 mg subcutaneously in the FORTIFY trial.

The team evaluated clinical and endoscopic outcomes in patient subgroups stratified by Crohn’s disease at baseline—ileal only, colonic only, and ileal-colonic—using non-responder imputation incorporating multiple imputation to handle missing data because of COVID-19.

The investigators sought co-primary endpoints of CD Activity Index (CDAI) clinical remission and endoscopic response.

Results at Week 12

At week 12, the investigators found a significantly greater proportion of patients in the risankizumab 600 mg intravenous group achieved the co-primary endpoints compared to placebo in the colonic only (n = 190) and ileal-colonic (n = 252) subgroups (P <.001)

There was also statistically higher proportions of risankizumab treated patients who achieved the composite endpoint CDAI clinical remission and endoscopic response.

This was also true for endoscopic remission in the colonic only and ileal-colonic subgroups compared to placebo (P <.001)

At week 52 there was a significantly greater proportion of patients in the risankizumab 360 mg subcutaneous group who achieved the co-primary endpoints CDAI clinical remission and endoscopic response, composite CDAI clinical remission and endoscopic response, and endoscopic remission compared to placebo subcutaneous in the colonic only (n = 59) and ileal-colonic (n = 67) subgroups (≤.05).

After 12 weeks of intravenous risankizumab, which was baseline of the maintenance study of patients with endoscopic remission, significantly more patients treated with risankizumab achieved sustained endoscopic remission at week 52 compared placebo subcutaneous in the colonic only and ileal-colonic subgroups (P ≤.01). The efficacy rates at weeks 12 and 52 were numerically lower in ileal only Crohn’s disease relative to the other 2 groups. However, the results for ileal only Crohn’s disease were limited by a small number of patients in the subgroup (induction, n = 85; maintenance, n = 15).

“RZB induction and maintenance therapy was effective in patients with moderately to severely active CD with greater benefits observed in patients with any colonic involvement,” the authors wrote.

The study, “OP40 Efficacy of risankizumab induction and maintenance therapy by baseline Crohn’s Disease location: Post hoc analysis of the phase 3 ADVANCE, MOTIVATE, and FORTIFY studies,” was published online by the European Crohn’s and Colitis Organisation.


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