Efficacy of Risankizumab for the Treatment of Moderate-to-Severe Crohn’s Disease Patients: Real-World Data
PI: Dr. Talat Bessissow, McGill University
Co-Investigators
Dr. Peter Lakatos, McGill University
Dr. Mark Silverberg, University of Toronto
Dr. Vipul Jairath, Western University
Dr. Chris Ma, University of Calgary
Dr. Neeraj Narula, McMaster University
Dr. Jeffrey McCurdy, The University of Ottawa
Dr. Greg Rosenfeld, University of British Columbia
Dr. Farhad Peerani, University of Alberta
Purpose
Given the limited efficacy of anti-TNF therapy, novel medical therapy has emerged as alternative first line biologics for the treatment of CD. Risankizumab, an anti-IL-23 has been shown to be efficacious for the treatment of CD. Patients included in clinical trials represent a minority of patients seen in clinical practice. Real world data is very scant. Therefore, we will perform a retrospective study to assess the efficacy of risankizumab in the treatment of moderate-to-severe CD patients.
Study Design
A retrospective, multicenter, non-interventional, chart review study to describe the treatment of patients diagnosed with moderate-to-severe CD with risankizumab in a clinical practice setting. Patients documented in this study will have a diagnosis of moderate-to-severe CD that has been treated with at least 3 IV doses of risankizumab 600mg and who have a minimum of 12 months of data available in their medical chart following initiation of risankizumab. All study objectives will be evaluated in an intention-to-treat framework. Clinical Remission will be defined as a CDAI of <150, or HBI score of < 5, or determined by physician assessment (inactive disease) when HBI or CDAI scores are unavailable.
Participating Sites
McGill University
University of Toronto
Western University
University of Calgary
University of Ottawa
McMaster University
University of British Columbia
University of Alberta
Targets
Inclusion period: January 2023 to September 2024