TOPLINE:

Among patients with moderate-to-severe Crohn’s disease who had inadequate response to prior anti-TNF therapies, risankizumab led to greater improvements in quality-of-life (QOL) measures and certain physical and emotional symptoms than ustekinumab.

METHODOLOGY:

• Restoring normal health-related QOL (HRQOL) is a core treatment goal in Crohn’s disease, which impairs physical, emotional, and social functioning. Although risankizumab and ustekinumab are FDA-approved for moderate-to-severe disease, direct comparisons of their effects on HRQOL are lacking.
• Researchers conducted a post hoc analysis of data from a phase 3b study to compare the treatment effect of risankizumab vs ustekinumab on improvements in HRQOL measures, including clinically meaningful improvements in patient-reported outcomes.
• A total of 520 patients with moderate-to-severe Crohn’s disease who previously did not respond to anti-TNF therapy were randomly assigned to receive recommended induction and maintenance doses of either risankizumab (n = 255; mean age, 38 years; 53.3% male) or ustekinumab (n = 265; mean age, 38.3 years; 49.4% male).
• All patients completed the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ) that covered bowel, systemic, emotional, and social functions and a 36-item Short Form Health Survey version 2 that assessed physical and mental health; higher scores indicate better HRQOL.
• The outcomes were the proportion of patients achieving IBDQ response and remission and meaningful within-person changes in the physical component summary (PCS) and mental component summary (MCS) scores of SF-36v2 at weeks 24 and 48.

TAKEAWAY:

• A significantly greater proportion of patients achieved IBDQ response with risankizumab vs ustekinumab at week 24 (75.3% vs 64.2%; P ≤ .01), with sustained response at week 48 (68.6% vs 50.9%; P ≤ .001).
• IBDQ remission was achieved in a significantly greater proportion of patients with risankizumab vs ustekinumab at week 24 (52.5% vs 30.9%; P ≤ .001) and week 48 (49.8% vs 33.2%; P < .001).
• At week 24, a significantly lower proportion of patients on risankizumab than on ustekinumab reported experiencing fatigue, difficulty sleeping, depression, anxiety, or bowel urgency all the time or some of the time (P < .05 for all).
• A significantly greater proportion of patients achieved meaningful within-person changes in PCS scores with risankizumab vs ustekinumab at week 24 (65.9% vs 53.2%; P ≤ .01) and week 48 (63.9% vs 46.0%; P ≤ .001) and in MCS scores at week 48 (54.1% vs 40.0%; P ≤ .01).

IN PRACTICE:

“[The study] findings underscore the potential of RZB [risankizumab] to enhance overall QOL [quality of life] for this patient population and highlight the importance of consistently incorporating PROs [patient-reported outcomes] in clinical research to ensure treatment decisions are patient-centered,” the authors of the study concluded.

SOURCE:

The study was led by Edward V. Loftus, Jr, MD, Mayo Clinic College of Medicine and Science, Rochester, Minnesota. It was published online in the American Journal of Gastroenterology.

LIMITATIONS:

The open-label design may have influenced how patients reported outcomes. Patients in the ustekinumab group experienced a higher rate of discontinuation than those in the risankizumab group. The trial population was restricted to patients who did not respond to prior anti-TNF therapy, limiting generalizability to biologic-naive patients and potentially to broader real-world populations.

DISCLOSURES:

The study was funded by AbbVie. Six authors reported being full-time employees of the funding company and may have owned stock or stock options. Some other authors reported receiving research support, educational grant, consulting fees, speaking and advisory board fees, and other ties with various pharmaceutical companies and institutions.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.