HRQoL, Treatment Satisfaction With Risakizumab in ASPIRE-CD, With Laurie Keefer, PhD

As the treatment landscape for Crohn’s disease (CD) continues to advance, clinicians are increasingly recognizing that true remission involves more than just mucosal healing or symptom control. Patient-reported outcomes have emerged as a critical component of understanding treatment success.

At the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting, Laurie Keefer, PhD, a clinical health psychologist and professor of medicine at Icahn School of Medicine at Mount Sinai, presented data from the prospective, observational ASPIRE-CD study highlighting treatment satisfaction and positive treatment experiences with risankizumab as well as data demonstrating the IL-23 inhibitor’s real-world impacts on health-related quality of life (HRQoL) in patients with CD.

“At this point, we're really striving not just for that physical, endoscopic healing, but really that emotional healing too,” Keefer explained to HCPLive, emphasizing the importance of factors like fatigue, sexual function, and treatment satisfaction for achieving long-term maintenance of remission.

An ongoing, observational, prospective, longitudinal patient survey study, ASPIRE-CD enrolled adult patients with CD prescribed with risankizumab and enrolled in the risankizumab patient support program in the US. In total, the study included 286 patients who initiated risankizumab intravenously, the majority of whom were female (57.0%), bio-/Janus kinase inhibitor-experienced (79.0%), with a mean age of 45.7 (standard deviation [SD], 14.8) years and disease duration of 14.2 (SD, 14.0) years.1

A total of 241 (84.3%) patients completed the Week 12 survey. At baseline, half of the patients reported being at least somewhat satisfied with their CD treatments; by Week 12, most (77.6%) were at least somewhat satisfied (P <.01).1

At Week 12, 186 patients had used the on-body injector and the majority reported that the injection device was easy or very easy to learn (84.9%) and to use (87.1%). Of note, the majority of these patients (91.9%) were satisfied or very satisfied with the injection device.1

Additionally, a large proportion of patients reported using the patient support program services by Week 12 (87.6%); the overall satisfaction was high among them, with 92.7% being somewhat or very satisfied with the patient support program.1

Additional HRQoL data presented at ACG showed 36.5% and 38.2% of patients who completed the Week 12 survey achieved IBDQ response at Weeks 4 and 12, respectively. At Week 12, patients achieving IBDQ remission increased from 34.3% at baseline to 54.8% (P <.001) and the mean SF-12 PCS increased from 46.2 to 49.0 (P <.001).2

The mean SF-12 MCS remained stable overall and for most MCS domains through 12 weeks, except for the mean social functioning domain score, which increased from 45.4 to 48.2 (P <.01). Among patients who experienced fatigue at baseline, 23.1% achieved FACIT-Fatigue response by Week 12. Additionally, at Week 12, patients reporting that CD “very much” negatively affected sexual interest/activity decreased from 19.8% at baseline to 12.6%, whereas those who answered “not at all” increased from 31.6% to 44.2% (P <.01).2

“I think patient perceptions and experiences were really prioritized here, and I think that that is something that we really need to aspire to do going forward, where we're incorporating that real-world patient experience and not just some of our clinical outcome measures like mucosal healing, which is obviously very important, but going really hearing from that patient voice,” Keefer said.

Editors’ note: Keefer reports relevant disclosures with AbbVie, Ardelyx, Eli Lilly, Janssen, Pfizer, and others.

References

1. Keefer L, Griffith JM, Yang M, et al. Treatment Satisfaction and Patients’ Experiences with Risankizumab On-Body Injector Among Adults With Crohn's Disease in Clinical Practice: Initial Results From the ASPIRE-CD Study. Presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting. Phoenix, Arizona. October 27-29, 2025.

2. Keefer L, Abraham B, Griffith JM, et al. Real-World Impact of Risankizumab on Health-Related Quality of Life in Adults With Crohn’s Disease: Initial Results From the ASPIRE-CD Study. Presented at the American College of Gastroenterology (ACG)’s 2025 Annual Scientific Meeting. Phoenix, Arizona. October 27-29, 2025.