A pivotal study comparing risankizumab (Skyrizi) to ustekinumab for the treatment of moderate-to-severe Crohn's disease was published on January 1, 2024. This publication details the findings from a trial designed to assess changes in the Crohn's Disease Activity Index (CDAI) in adult participants.

Background

Risankizumab (Skyrizi) and ustekinumab are both biological therapies used in the treatment of inflammatory conditions. This pivotal study focused on their comparative efficacy in adult participants with moderate-to-severe Crohn's disease, a chronic inflammatory condition affecting the digestive tract.

Trial design

The SEQUENCE study, titled "Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Dis", compared risankizumab administered intravenously (IV) and subcutaneously (SC) against ustekinumab, also administered IV and SC. The primary objective of the trial was to assess the change in the Crohn's Disease Activity Index (CDAI) in adult participants suffering from moderate-to-severe Crohn's disease.

What this means

The publication of this pivotal study provides clinicians and researchers with detailed data comparing risankizumab and ustekinumab for the treatment of moderate-to-severe Crohn's disease. While specific outcome measurements are not provided in the summary data, the study's focus on assessing changes in the Crohn's Disease Activity Index (CDAI) indicates its relevance for understanding comparative efficacy in this patient population. The findings will contribute to evidence-based decision-making regarding treatment options for Crohn's disease.

Source

The information regarding this pivotal study was published on January 1, 2024, in the New England Journal of Medicine, as indexed by PubMed. The publication, titled "Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn's Disease", is accessible via pubmed.ncbi.nlm.nih.gov.