ASPIRE-CD Highlights Patient-Reported Symptom Gains With Risankizumab in Crohn Disease

Patient-reported outcomes are becoming increasingly central to Crohn disease management, particularly as clinicians aim to understand not only inflammatory control but also how treatment affects daily functioning, fatigue, pain, bowel urgency, and quality of life.

In the ASPIRE-CD study, investigators evaluated patient-reported outcomes over time among real-world patients with Crohn disease receiving risankizumab. Findings showed rapid and sustained symptom improvement, including early changes by week 2, as well as reductions in corticosteroid and over-the-counter medication use.

In the following Q&A, Laurie Keefer, PhD, discusses the clinical need behind ASPIRE-CD, why early symptom improvement matters to patients, and how patient-centered measures can help inform shared decision-making in Crohn disease care.

Q: Can you explain the clinical need that led to the design of the ASPIRE-CD study, and why it is important to capture patient-reported outcomes in practice?

Keefer: What is really exciting about ASPIRE-CD is that it looks at patient-reported outcomes over time in a group of people who need that support through a patient support program.

So often, we fail to fully appreciate the impact that symptoms like fatigue, pain, and bowel urgency have on patients. Being able to follow those symptoms longitudinally in the real world is important.

These are not just patients enrolled in clinical trials. These are real-life patients, and the ASPIRE-CD study was really geared toward understanding that experience.

Q: The study showed rapid and sustained symptom improvement after starting risankizumab, including early changes by week 2. Why does that timing of response matter?

Keefer: Timing of response really matters to patients. When we encourage patients to take medications, they want to know what to expect: How long will it take for me to feel better? What should I be looking for?

For symptoms like fatigue and pain, even a little bit of early relief can go a long way. It can improve optimism, hope for the future, and confidence in managing the disease.

That conversation is part of shared decision-making. Being able to tell a patient that they may start to feel better by week 2—even if it is not a perfect outcome yet—is meaningful.

Q: Fatigue and extraintestinal manifestations can be difficult to manage in Crohn disease. What stood out to you about the improvements seen in these domains?

Keefer: First of all, what stood out is that we asked about them.

So often, symptoms such as fatigue and extraintestinal manifestations are pushed aside as less important, or they become an afterthought. To rigorously measure fatigue, extraintestinal manifestations, and their impact on function—including sexual function—was an important part of this study.

The fact that these domains were measured systematically and proactively was a major addition.

Q: The study also reported meaningful reductions in corticosteroid and over-the-counter medication use. How does that align with current treatment goals and steroid-sparing strategies?

Keefer: This reflects the current direction of treatment goals. We want patients to live well long term without needing over-the-counter medications and certainly without needing corticosteroids.

Adding medication-use outcomes alongside measures such as fatigue and extraintestinal manifestations completes the picture and makes the study much more patient-centered.

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