P5321 - Investigating Unmet Needs Among Advanced Therapy-Naïve Patients With Crohn’s Disease Treated With Ustekinumab or Risankizumab

Freddy Caldera, DO, PhD, MS¹, Maryia Zhdanava, MA²,Sumesh Kachroo, PhD³, Aditi Shah, MA⁴, Lilian Diaz, MSc², Fengyi Jiang, MSc⁴, Caroline Kerner, MD, MSc³, Dominic Pilon, MA², Jennifer Seminerio, MD⁵
1University of Wisconsin Hospitals and Clinics, Madison, WI; 2Analysis Group, Inc., Montreal, PQ, Canada; 3Johnson & Johnson, Horsham, PA; 4Analysis Group, Inc., Toronto, ON, Canada; 5Department of Gastroenterology and Hepatology, AdventHealth Orlando, Orlando, FL

Introduction: New advanced therapies (ATs) targeting interleukin (IL)-23 have been approved for Crohn’s disease (CD) in the US and may address unmet needs. This study sought to compare suboptimal treatment and healthcare resource utilization (HRU) among AT-naïve patients initiated on previously approved IL-12/23 inhibitor ustekinumab or IL-23 inhibitor risankizumab.

Methods: This retrospective cohort study used Komodo Research Data, a US medical and pharmacy claims database. Adults with CD who initiated ustekinumab or risankizumab (index date) between 06/17/2022 and 11/30/2023 were included. Patients had ≥12 months of baseline insurance coverage without CD-indicated AT use pre-index. Baseline characteristics between cohorts were balanced with inverse probability of treatment weights. A composite outcome of suboptimal treatment included: CD-related hospitalization or emergency room (ER) visit, CD-related surgery, AT switch, addition of corticosteroids (CS), immunomodulators or 5-aminosalicylic acid, or dose escalation >100% of labeled maintenance dose. Time to event from maintenance phase start was analyzed with weighted Kaplan-Meier and Cox proportional hazards models. Patients without event were censored at end of index therapy supply. Poisson regression models were used to compare HRU between cohorts from treatment initiation.

Results: A total of 2,218 patients initiated ustekinumab and 858 initiated risankizumab; baseline characteristics were balanced for ustekinumab vs risankizumab (mean age: 44.9 vs 44.4 years; female: 53.3% vs 53.6%; CS use: 63.8% vs 64.7%). After 6 months of maintenance, there was no difference in risk of suboptimal treatment (37.0% ustekinumab and 35.2% risankizumab; hazard ratio [HR]=1.13; p=0.121; Figure 1), including risk of CD-related surgery (HR=0.63; p=0.081), switch to a new AT (HR=1.35; p=0.368), and corticosteroid augmentation (HR=1.00; p=0.999). The risk of CD-related hospitalization or ER visit was significantly higher on risankizumab (HR=0.70; p=0.013). No significant differences were observed in HRU between cohorts post-index (Figure 2).

Discussion: Over a third of AT-naïve patients with CD experienced suboptimal treatment with ustekinumab and risankizumab after 6 months of maintenance, with risks and HRU similar for both therapies; potentially highlighting unmet treatment needs with these agents. Future work should focus on more recently approved IL-23 agents, including guselkumab and mirikizumab.


Figure: Figure 1. Kaplan-Meier risk of suboptimal treatment during follow-up period.
Abbreviations: ASA: aminosalicylic acid; AT: advanced therapy; ER: emergency room; HR: hazard ratio; CD: Crohn’s disease.


Figure: Figure 2: HRU during follow-up period.
Abbreviations: CI: confidence interval; HRU: healthcare resource utilization; IP: inpatient; ER: emergency room; OP: outpatient; RR: rate ratio; UST: ustekinumab.

Disclosures:
Freddy Caldera: GSK – Consultant. GSK – Grant/Research Support. Janssen – Consultant. Novavax – Grant/Research Support.
Maryia Zhdanava: Analysis Group, Inc. – Employee. Johnson & Johnson – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson.
Sumesh Kachroo: Johnson & Johnson – Employee, Stock Options.
Aditi Shah: Analysis Group, Inc. – Employee. Johnson & Johnson – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson.
Lilian Diaz: Analysis Group, Inc. – Employee. Johnson & Johnson – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson.
Fengyi Jiang: Analysis Group, Inc. – Employee. Johnson & Johnson – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson.
Caroline Kerner: Johnson & Johnson – Employee, Stock Options.
Dominic Pilon: Analysis Group, Inc. – Employee. Johnson & Johnson – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson.
Jennifer Seminerio: Abbvie – Consultant. Johnson & Johnson – Consultant. Lilly – Consultant. Pfizer – Consultant. Sanofi – Consultant. Takeda – Consultant.

Freddy Caldera, DO, PhD, MS¹, Maryia Zhdanava, MA², Sumesh Kachroo, PhD³, Aditi Shah, MA⁴, Lilian Diaz, MSc², Fengyi Jiang, MSc⁴, Caroline Kerner, MD, MSc³, Dominic Pilon, MA², Jennifer Seminerio, MD⁵. P5321 - Investigating Unmet Needs Among Advanced Therapy-Naïve Patients With Crohn’s Disease Treated With Ustekinumab or Risankizumab, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.