Risankizumab’s 1 Year Crohn's Disease Improvement in HRQL and Wellbeing in ASPIRE-CD

1-year results from ASPIRE-CD suggest risankizumab (Skyrizi) may improve general well-being and health-related quality of life (HRQL) in adults with moderately to severely active Crohn’s Disease (CD) compared with their baseline.1

The data were presented at Digestive Disease Week (DDW) 2026, including improvements in sexual health, work productivity, daily activity levels, life enjoyment, and treatment satisfaction 1 year after patients started taking risankizumab.1

Addressing An Unmet Need in Crohn’s Disease With ASPIRE-CD

ASPIRE-CD is an ongoing, observational, prospective, longitudinal patient survey study evaluating real-world experiences of adults with moderately to severely active CD who are treated with risankizumab in clinical practice, with investigators citing the importance of these patient-centered outcomes.

“To rigorously measure fatigue, extra-intestinal manifestations, and the impact on sexual function was the first time that we were able to look at and ask about that. The fact that it was even measured systematically, proactively as part of the study, was a huge addition,” said study investigator and abstract presenter Laurie Keefer, PhD, a clinical health psychologist and professor of medicine, psychiatry, and biomedical sciences at the Icahn School of Medicine at Mount Sinai, in an interview with HCPLive. “Often, those symptoms are pushed aside as not super important, or they're an afterthought.”

ASPIRE-CD’s Trial Design

Before initiating risankizumab intravenously and after 52 weeks, APIRE-CD participants completed surveys addressing life enjoyment, the negative impact of CD on sexual interest/activity, and satisfaction with treatment, which were evaluated using a 4-week recall and Likert scales. Additional data collection included the Short Form (SF)-12 version 2 Health Survey and the Work Productivity and Activity Impairment Questionnaire: CD (WPAI: CD).

ASPIRE-CD included 286 patients, of which 74.5% completed the Week 52 survey (n = 213), and 86.4% remained on risankizumab (n = 184). The trial population was 57.0% female, had a mean age of 45 years, 90.2% were White, and 75.2% were biologic- or Janus kinase inhibitor-experienced.

Results From A Patient-Centered Approach

At Week 52, 77.0% of patients reported improvement in life enjoyment since starting risankizumab:

• A little improved: 21.1%
• Moderately improved: 24.9%
• Much improved: 31.0%

Among patients indicating sexual interest/activity, the proportion who reported being at least somewhat satisfied with their sex life increased from 35.5% at baseline to 51.5% at Week 52 (P < .001). The proportion of patients reporting that CD had no negative impact on their sexual interest/activity increased from 31.6% to 51.2% (P < .001).

Overall satisfaction with CD treatments improved from 50.0% at baseline

• Extremely satisfied: 5.2%
• Very satisfied: 15.0%
• Somewhat satisfied: 29.7%

Investigators noted an increase to 86.9% among all survey completions:

• Extremely satisfied: 25.8%
• Very satisfied: 38.5%
• Somewhat satisfied: 22.5%

Including a 92.4% among patients remaining on risankizumab at Week 52:

• Extremely satisfied: 27.7%
• Very satisfied: 40.8%
• Somewhat satisfied: 23.9%

“When we push patients to take medications, they want you to set expectations. How long will it take for me to feel better? What should I be looking for? And with fatigue and pain, a little bit of relief early on can go a long way for patient optimism, hope for the future, and a sense of confidence about being able to manage it,” Keefer said. “That conversation, the shared decision making that goes on by being able to say 2 weeks, you know, might not be a perfect outcome, but you're going to start to feel better, is gold for patients.”

Investigators also observed significant improvements in the physical component summary of the SF-12v2 with a baseline of 46.2 [9.40] compared to a Week 52: 49.8 [9.4] (P <.001) and all domains of the WPAI through Week 52.

Editor’s Note: Keefer reports relevant disclosures with Ardelyx, Trellus Health, Fzata, AbbVie, and others.

References

1. Lauren Keefer. RISANKIZUMAB IMPROVES HEALTH-RELATED QUALITY OF LIFE IN ADULTS WITH CROHN'S DISEASE: YEAR 1 RESULTS FROM THE ASPIRE-CD STUDY. Poster presented at: Digestive Disease Week; May 2-5, 2026; Chicago, IL.

2. Keefer L. HRQoL, Treatment Satisfaction With Risakizumab in ASPIRE-CD, With Laurie Keefer, PhD. HCPLive. Published October 29, 2025. Accessed May 5, 2026. https://www.hcplive.com/view/hrqol-treatment-satisfaction-with-risakizumab-aspire-cd-with-laurie-keefer-phd