P5477 - Demographics and Clinical Characteristics of Patients With Ulcerative Colitis Receiving First-Line Advanced Therapies Categorized in AGA Guidelines as Lower, Intermediate, and Higher Efficacy

Anita Afzali, MD, MPH, MHCM¹, Emily Gravlee, PharmD, PhD², Kiraat D. Munshi, PhD², Wenzhuo Zhao, MS³, Zheng Si, MA³, Jennifer Friderici, MS³, Abbey Wojtowicz, PhD², Ben Muller, PharmD², Joshua Brown, PharmD, PhD²
1Department of Internal Medicine, Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati, OH; 2Takeda Pharmaceuticals U.S.A., Inc., Cambridge, MA; 3KMK Consulting Inc., Morristown, NJ

Introduction: Advanced therapies (AT) are indicated in patients with moderately-to-severely active ulcerative colitis (UC); however, prescribing patterns vary based on prescriber experience and patient preference. The 2024 American Gastroenterological Association (AGA) guidelines stratify first-line AT in adult patients with UC by lower, intermediate, and higher efficacy.¹ We aimed to describe how the demographic and clinical characteristics of adult patients with UC who initiate AT in the USA vary by efficacy classification.

Methods: This study used claims data from IQVIA PharMetrics Plus and Optum Insights Clinformatics® Data Mart databases between January 1, 2018 and December 31, 2022, and January 1, 2018 and September 30, 2024, respectively. Patients with UC with ≥ 1 claim for a first-line AT and aged ≥ 18 years old at AT initiation were included. Patients were categorized into the higher (etrasimod, infliximab, ozanimod, upadacitinib, and vedolizumab), intermediate (golimumab, mirikizumab, tofacitinib, and ustekinumab), and lower (adalimumab) efficacy groups. Not all medications were identified owing to approval dates for UC and data periods. Characteristics were compared between groups using independent sample t-tests or Fisher exact tests.

Results: In total, 3,833 and 2,719 patients were included from the IQVIA and Optum databases, respectively, with a substantial proportion of patients in the lower efficacy group (lower: 34.9% and 23.8%; intermediate: 8.8% and 12.3%; higher: 56.4% and 64.0%; Figure 1). Within the higher efficacy group in IQVIA and Optum databases, respectively, 59.5% and 61.7% received vedolizumab, 39.7% and 34.8% received infliximab, and < 1% and 3.5% received other treatments. Age was significantly associated with higher vs. lower efficacy groups and, notably, the proportion of patients aged ≥ 65 years was higher in the higher versus lower efficacy groups for both IQVIA (6.7% vs. 4.0%) and Optum (40.1% vs. 17.2%) (Table 1). In both databases, patients in the higher efficacy group had significantly higher UC severity scores than the intermediate and lower efficacy groups (p ≤ 0.001 for all).

Discussion: These data show that higher efficacy, first-line AT in UC is associated with greater age and UC severity. Yet, a substantial proportion of patients with UC receive lower efficacy first-line AT, indicating that prescribing patterns may not align with evidence-based recommendations.

References
1. Singh, S et al. Gastroenterol. 2024;167(7):1307-43.


Figure: Figure 1. Proportion of patients who received first-line advanced therapies stratified into higher, intermediate, and lower efficacy groups.

As per the 2024 AGA guidelines, first-line advanced therapies were stratified into lower (adalimumab), intermediate (golimumab, mirikizumab, tofacitinib, and ustekinumab), and higher (etrasimod, infliximab, ozanimod, upadacitinib, and vedolizumab) efficacy groups.


Figure: Table 1. Baseline demographics and clinical characteristics in patients with UC receiving higher, intermediate, or lower efficacy first-line advanced therapies in the IQVIA and Optum databases.

aPatients in the higher efficacy category received infliximab, ozanimod, upadacitinib, or vedolizumab. bPatients in the intermediate efficacy category received golimumab, tofacitinib, or ustekinumab. cPatients in the lower efficacy category received adalimumab. dIn the Optum database, sex was recorded as unknown for one patient in the higher efficacy group. eIn the IQVIA database, payer type was recorded as unknown for four patients in the higher efficacy group and one patient in the lower efficacy group. CCI, Charlson Comorbidity index; SD, standard deviation; UC, ulcerative colitis.

Disclosures:
Anita Afzali: AbbVie – Advisory Committee/Board Member, Consultant, Speaker fees. Bristol Myers Squibb/Celgene – Consultant. DiaSorin – Consultant. Eli Lilly – Advisory Committee/Board Member, Consultant. Gilead – Consultant. IBD Horizons – Consultant. Johnson & Johnson – Advisory Committee/Board Member, Consultant, Speaker fees. Pfizer – Advisory Committee/Board Member, Consultant, Speaker fees. Scrubs & Heels Foundation – Advisory Committee/Board Member, Consultant, Co-Founder. Takeda – Advisory Committee/Board Member, Consultant, Speaker fees. TLL Pharmaceuticals – Consultant.
Emily Gravlee: Takeda Pharmaceuticals U.S.A., Inc – Consultant.
Kiraat Munshi: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Wenzhuo Zhao: KMK Consulting Inc. – Employee.
Zheng Si: KMK Consulting Inc. – Employee.
Jennifer Friderici: KMK Consulting Inc. – Employee.
Abbey Wojtowicz: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Ben Muller: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Joshua Brown: Takeda Pharmaceuticals U.S.A., Inc. – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).

Anita Afzali, MD, MPH, MHCM¹, Emily Gravlee, PharmD, PhD², Kiraat D. Munshi, PhD², Wenzhuo Zhao, MS³, Zheng Si, MA³, Jennifer Friderici, MS³, Abbey Wojtowicz, PhD², Ben Muller, PharmD², Joshua Brown, PharmD, PhD². P5477 - Demographics and Clinical Characteristics of Patients With Ulcerative Colitis Receiving First-Line Advanced Therapies Categorized in AGA Guidelines as Lower, Intermediate, and Higher Efficacy, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.