P5426 - Real-World Impact of Risankizumab on Health-Related Quality of Life in Adults With Crohn’s Disease: Initial Results From the ASPIRE-CD Study

Laurie Keefer, PhD, FACG¹, Bincy Abraham, MD, MS, FACG², Jenny M. Griffith, PharmD³, Min Yang, MD⁴, Erin E. Cook, PhD⁵, Javier Zambrano, MD⁶, Julia Vishnevetsky, MPH⁷, Bruno Martins, PhD⁵, Aline Charabaty, MD, FACG⁸
1Icahn School of Medicine at Mount Sinai, New York, NY; 2Division of Gastroenterology & Hepatology, Houston Methodist-Weill Cornell, Houston, TX; 3AbbVie Inc, North Chicago, IL; 4Analysis Group, Inc, Boston, MA; 5Analysis Group, Inc., Boston, MA; 6AbbVie Inc., North Chicago, IL; 7AbbVie, North Chicago, IL; 8Johns Hopkins University School of Medicine, Washington, DC

Introduction: Restoring health-related quality of life (HRQL) is an important long-term treatment target for patients with Crohn’s disease (CD). Risankizumab (RZB), an IL-23 p19 inhibitor, has shown improvements in HRQL for patients with moderate to severe CD in clinical trials. Here, we report initial results of real-world impact of RZB treatment on HRQL in patients with CD from the prospective, observational ASPIRE-CD study.

Methods: Adult patients who enrolled in the RZB patient support program in the USA were invited to participate in ASPIRE-CD. Patients were asked to complete a survey at baseline and at weeks (wks) 2, 4, and 12 after the first RZB induction dose. The survey assessed different CD-related aspects of HRQL via the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short-Form 12-Item Survey (SF-12 v2) physical and mental component scores (PCS and MCS), the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue), and the impact of CD on sexual interest/activity.

Results: Of 286 patients who received the first RZB induction dose, 241 (84.3%) completed the 12-wk survey. Those completing the wk12 survey had an average age of 46.1 years, 57.7% were female, and 74.3% had prior biologic or Janus kinase inhibitor (JAKi) exposure with 43.6% having ≥ 2 prior biologics or JAKis in their treatment history at baseline. The proportion of patients who achieved IBDQ response at wks 4 and 12 were 36.5% and 38.2%, respectively (Fig. 1A). At wk12, patients achieving IBDQ remission increased from 34.3% at baseline to 54.8% (P < .001; Fig. 1B) and the mean SF-12 PCS increased from 46.2 to 49.0 (P < .001; Fig. 1C). The mean SF-12 MCS remained stable overall and for most MCS domains through 12 wks, except for the mean social functioning domain score, which increased from 45.4 to 48.2 (P < .01). Among patients who experienced fatigue (FACIT-Fatigue score of < 40) at baseline (189/286 [66.1%]), 23.1% achieved FACIT-Fatigue response by wk12 (Fig. 2A). At wk12, 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; Fig. 2B).

Discussion: Initial results from the ASPIRE-CD study showed improvements in HRQL, including reduced fatigue and improved sexual interest/satisfaction, from baseline to as early as 4 wks of RZB initiation, which continued through wk12. Future data will characterize the long-term real-world experiences of these patients.


Figure: Figure 1. Patients With CD who Initiated RZB and Achieved IBDQ Response, IBDQ Remission, and SF-12v2 Component Scores.

Abbreviations: HRQL, health-related quality of life; IBDQ, Inflammatory Bowel Disease Questionnaire; N, number; RZB, Risankizumab; SF-12v2, Short-Form 12-Item Survey-version 2.
* P < .05, ** P < .01, *** P < .001.
Baseline includes patients who initiated RZB with induction dosage administered by intravenous infusion. Statistical comparisons between baseline and post-treatment outcomes were conducted using Chi-square/Fisher’s exact tests for categorical variables.
a≥ 16 point increase in IBDQ total score (source: Aladraj H, et al. J Clin Med. 2022. 11:3743).
bIBDQ total score ≥ 170 points.
cScoring is normalized with a mean of 50 and a standard deviation of 10 in the general population where higher scores indicate better HRQL.



Figure: Figure 2. Patient Changes in Fatigue and Sexual Interest/Satisfaction.

Abbreviations: CD, Crohn’s disease; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; N, number; RZB, Risankizumab.
* P < .05, ** P < .01.
Baseline includes patients who initiated RZB with induction dosage administered by intravenous infusion. Statistical comparisons between baseline and post-treatment outcomes were conducted using Chi-square/Fisher’s exact tests for categorical variables.
aAmong patients who experienced fatigue at baseline. Fatigue at baseline is defined as patients with a FACIT-Fatigue score of < 40 at baseline (source: Louis E, et al. Dig Liver Dis. 2025. 57:707–15).
bSource: Regueiro M, et al. Qual Life Res. 2025. 34:509-521).
cNumber of respondents are those that did not select “Not applicable” for the question “In the past 4 weeks, how much has your sexual interest and/or activity been negatively affected by Crohn’s disease?”.

Disclosures:
Laurie Keefer: AbbVie – Consultant. Ardelyx – Consultant. Eli Lilly – Consultant. Janssen – Consultant. Pfizer – Consultant. Reckitt Health – Consultant. Trellus Health – Owner/Ownership Interest, Stock-publicly held company(excluding mutual/index funds).
Bincy Abraham: Abbvie – Consultant, Speakers Bureau. Celltrion – Consultant. Eli Lilly – Consultant, Speakers Bureau. Johnson and Johnson – Consultant, Speakers Bureau. Pfizer – Consultant. Sanofi – Consultant. Takeda – Consultant, Speakers Bureau.
Jenny M. Griffith: AbbVie – Employee, Stock Options.
Min Yang: Analysis Group, AbbVie Inc. – Consultant.
Erin Cook: Analysis Group, AbbVie Inc. – Consultant.
Javier Zambrano: AbbVie Inc. – Employee, Stock Options.
Julia Vishnevetsky: AbbVie Inc. – Employee, Stock Options.
Bruno Martins: Analysis Group, AbbVie Inc. – Consultant.
Aline Charabaty: AbbVie – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Celltrion – Grant/Research Support. Eli Lilly – Advisory Committee/Board Member, Consultant. guardant health – Consultant. Janssen – Advisory Committee/Board Member, Consultant. Pfizer Inc – Advisory Committee/Board Member, Consultant. sanofi – Advisor or Review Panel Member, Consultant. scrubs & heels foundation – co-founder. Takeda – Advisory Committee/Board Member, Consultant.

Laurie Keefer, PhD, FACG¹, Bincy Abraham, MD, MS, FACG², Jenny M. Griffith, PharmD³, Min Yang, MD⁴, Erin E. Cook, PhD⁵, Javier Zambrano, MD⁶, Julia Vishnevetsky, MPH⁷, Bruno Martins, PhD⁵, Aline Charabaty, MD, FACG⁸. P5426 - Real-World Impact of Risankizumab on Health-Related Quality of Life in Adults With Crohn’s Disease: Initial Results From the ASPIRE-CD Study, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.