Laurie Keefer, PhD, is a clinical health psychologist and professor of medicine at Icahn School of Medicine at Mount Sinai.

Laurie Keefer, PhD

Risankizumab’s 1 Year Improvement in HRQL and Wellbeing For Crohn’s Disease

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 

 2026, including improvements in sexual health, work productivity, daily activity levels, life enjoyment, and treatment satisfaction 1 year after patients started taking risankizumab.

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


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 

. “Often, those symptoms are pushed aside as not super important, or they're an afterthought.”

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.

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

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 (

< .001). The proportion of patients reporting that CD had no negative impact on their sexual interest/activity increased from 31.6% to 51.2% (

Overall satisfaction with CD treatments improved from 50.0% at baseline

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

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

“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] (

<.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.

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.

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

Videos

1-year results from ASPIRE-CD suggest risankizumab (Skyrizi) improves HRQL, well-being, and treatment satisfaction in adults with Crohn's Disease.

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

The Brain-Gut Connection in GI Clinical Practice

The gut microbiome has become a fixture of consumer wellness culture, but for practicing gastroenterologists, the clinical reality of gut health is considerably more nuanced.

At Digestive Disease Week (DDW) 2026 in Chicago, IL, Laurie Keefer, PhD, a health psychologist and professor of medicine at the Icahn School of Medicine at Mount Sinai, led a session calling on clinicians to expand their framework for gut health, one that accounts for the psychosocial forces shaping their patients' lives and explicitly integrates mental health into GI care.

"Gut health is a hot topic right now," Keefer told 

. "If you go on TikTok, it means one thing. If you come to DDW, it means another."

The Social Determinants Shaping Gut Health

For clinicians, gut health encompasses far more than diet or supplement use. Keefer emphasized that the full range of social determinants and lifestyle factors, including chronic stress, physical inactivity, loneliness, and ongoing exposure to conflict and geopolitical instability, all influence the gut microbiome and contribute to dysbiosis. Research has increasingly linked social isolation and loneliness to reduced gut microbial diversity, itself associated with a range of inflammatory and cardiometabolic conditions.

"All of our patients should be concerned about their gut health, because they live in this world today," Keefer said.

The Bidirectional Mental Health Connection

A central theme of Keefer's session was the inseparability of gut health and mental health. The United States is in the midst of a recognized mental health crisis, and the gut-brain axis sits squarely at the intersection of these public health challenges. The microbiota-gut-brain axis is a complex, bidirectional communication network linking the central nervous system and the gastrointestinal tract, with growing evidence that gut health can impact mental well-being and vice versa. For clinicians, this means that anxiety and depression are not merely comorbidities to be managed separately, but rather act as active drivers of gut dysfunction, and gut dysfunction can perpetuate them.

"You can have depression and anxiety that affects your gut health, and your gut health can lead to depression and anxiety," Keefer explained. "We really can't disentangle those two things."

The third pillar of Keefer's session addressed the clinical role of brain-gut behavior therapies (BGBTs), a class of interventions that includes cognitive behavioral therapy, gut-directed hypnotherapy, and other psychologically informed approaches. These therapies target not only lifestyle and mental health, but also the way patients perceive and respond to GI symptoms.

BGBTs are short-term, clinician-administered interventions, and a 2025 systematic review and network meta-analysis published in 

 found that several, particularly those classified as brain-gut behavior therapies, are efficacious for global IBS symptoms.

Keefer framed this perceptual component as underappreciated in routine care. How a patient interprets mild bloating, and what behavioral response that triggers, can meaningfully shape the downstream course of their gut symptoms.

"We're targeting things like lifestyle and behaviors and mental health, but also the way symptoms are perceived," she said. "Really full circle, but not separating gut health from mental health."

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

Keefer L. PSYCHOLOGICAL APPROACHES TO IMPROVE GUT HEALTH. Session presented at: Digestive Disease Week (DDW) 2026; Chicago, IL; May 2–5, 2026.

Culli L. Nearly 1 in 10 Adults in the U.S. Experienced a Mental Health Crisis Last Year. Johns Hopkins. August 19, 2025. Accessed May 3, 2026. 

https://publichealth.jhu.edu/2025/mental-health-crisis-hits-nearly-1-in-10-us-adults

Thakur ER, Khasawneh M, Moayyedi PM, et al. Efficacy of behavioural therapies for irritable bowel syndrome: a systematic review and network meta-analysis. The Lancet Gastroenterology & Hepatology. doi:

Laurie Keefer, PhD, makes the case for integrating mental health, social determinants, and brain-gut behavior therapies into routine GI care.

Rethinking Gut Health: Social Determinants, Mental Health, and Brain-Gut Therapies

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.

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 

, 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.

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 (

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.

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.

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% (

<.001) and the mean SF-12 PCS increased from 46.2 to 49.0 (

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 (

<.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% (

“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.

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.

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.

Keefer emphasizes the importance of treatment satisfaction and health-related quality of life in IBD and reviews findings from ASPIRE-CD.

Laurie Keefer, PhD

Articles