D0371 - Non-Biologic Medication Use Pre- and Post-Ustekinumab Initiation Among Patients With Ulcerative Colitis

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

SK

Sumesh Kachroo, PhD

Janssen Scientific Affairs, LLC
Horsham, Pennsylvania

Dominic Pilon, MA¹, Ruizhi Zhao, PhD², Ameur M. Manceur, PhD¹, Zhijie Ding, PhD, MS², Sumesh Kachroo, PhD², Maude Vermette-Laforme, BSc¹, Patrick Lefebvre, MA¹
¹Analysis Group, Inc., Montreal, PQ, Canada; ²Janssen Scientific Affairs, LLC, Horsham, PA

Introduction: Among patients with ulcerative colitis (UC), treatment with immunomodulators, 5-ASA (5-aminosalicylic acid), and corticosteroids while receiving biologic agents is common. However, real-world information on non-biologic medication use among UC patients initiated on ustekinumab is limited. This study compared non-biologic medication use pre- and post-ustekinumab initiation among UC patients.

Methods: Adults with UC initiated on ustekinumab (index date) between 10/18/2019 (FDA approval of ustekinumab for UC) and 10/31/2020 were selected from the de-identified health insurance claims Symphony Health Solutions’ Patient Transactional Datasets. Patients were excluded if they had a claim for Crohn’s disease anytime or for other autoimmune diseases pre-index. Patients were required to have: ≥1 claim for UC in the 12 months pre-index period (baseline), ≥2 ustekinumab claims within 90 days of the index date, and ≥6 months of follow-up. Non-biologic agent use in the 6 months period before and after the initiation of ustekinumab was compared with a logistic model estimated by generalized estimating equation. Results were reported as odds ratio with 95% confidence interval and p-values.

Results: A total of 760 patients with UC were initiated on ustekinumab and selected for the study (age 44.6 years old; 48.9% female; baseline biologic use 52.1% [potentially underestimated given the database open nature]; Quan-Charlson comorbidity index 0.62). The likelihood of immunomodulator and 5-ASA use decreased by 22% and 46%, after ustekinumab initiation (all P< 0.05). Similarly, patients were 52% less likely to use any corticosteroids and 34% less likely to use corticosteroids for ≥60 days (all P< 0.05). Further, there was no significant changes observed for the use of opioids (18.9% vs. 17.4%) or the use of anti-diarrheals (5.9% vs. 6.1%), and patients were 29% less likely to use GI antispasmodics after ustekinumab initiation (P< 0.05; Table 1). In a descriptive analysis, corticosteroids use numerically decreased at each month post-ustekinumab from 25.4% during the first 30 days following the index date compared to 17.4% within 150-180 days post-ustekinumab (Figure 1).

Discussion: In this real-world study of patients with UC, initiating ustekinumab was associated with a significant decrease in the use of immunomodulators, 5-ASA, and corticosteroids. Longer-term data are necessary to better understand non-biologic medication use after biologic initiation and inform treatment choice for patients with UC.

Figure: Figure 1. Corticosteroid use during the 6 months post-ustekinumab initiation (N=760)

	Pre-ustekinumab	Post-ustekinumab	Odds ratio¹(95% CI), p-value
	N = 760		Odds ratio¹(95% CI), p-value
Use of immunomodulators	120 (15.8)	97 (12.8)	0.78 (0.64, 0.95), 0.014*
Use of 5-ASA	312 (41.1)	208 (27.4)	0.54 (0.47, 0.62), < 0.001*
Use of corticosteroids	481 (63.3)	346 (45.5)	0.48 (0.41, 0.57), < 0.001*
Cumulative use² ≥60 days	243 (32.0)	180 (23.7)	0.66 (0.55, 0.79), < 0.001*
Cumulative use² ≥90 days	151 (19.9)	114 (15.0)	0.71 (0.58, 0.87), 0.001*
≥1 episode³ ≥ 60 days	201 (26.4)	156 (20.5)	0.72 (0.59, 0.87), < 0.001*
≥1 episode³ ≥ 90 days	118 (15.5)	89 (11.7)	0.72 (0.56, 0.93), 0.013*
Use of opioids	144 (18.9)	132 (17.4)	0.90 (0.74, 1.10), 0.296
Use of antidiarrheals	45 (5.9)	46 (6.1)	1.02 (0.76, 1.38), 0.879
Use of GI antispasmodics	86 (11.3)	63 (8.3)	0.71 (0.54, 0.93), 0.013*

Table: Table 1. Non-biologic medication use in the 6-month period before vs after the initiation of ustekinumab
Abbreviations: CI: Confidence interval; GI: Gastrointestinal; 5-ASA: 5-aminosalicylic acid
Notes: (1) Odds ratio obtained from a logistic model estimated with generalized estimating equation;
(2) Non-overlapping days of supply included; (3) A therapy exposure gap of 14 days of supply was used
to define continuous use

Disclosures:

Dominic Pilon: Analysis Group, Inc. – Employee, Employee of Analysis Group, Inc., a consulting company that has received research grants from Janssen Scientific Affairs,LLC, to conduct this study. Janssen Scientific Affairs, LLC – Consultant.

Ruizhi Zhao: Janssen Scientific Affairs LLC – Employee.

Ameur Manceur: Analysis Group, Inc. – Employee, Employee of Analysis Group, Inc., a consulting company that has received research grants from Janssen Scientific Affairs,LLC, to conduct this study. Janssen Scientific Affairs, LLC – Consultant.

Zhijie Ding: Janssen Scientific Affairs, LLC – Employee. Janssen Scientific Affairs, LLC – Employee. Janssen Scientific Affairs, LLC – Stock Options, Stock-publicly held company(excluding mutual/index funds).

Sumesh Kachroo: Johnson and johnson family of companies – Employee. Johnson and Johnson family of companies – Employee, Stock Options. Johnson and johnson family of companies – Stock Options.

Maude Vermette-Laforme: Analysis Group, Inc. – Employee, Employee of Analysis Group, Inc., a consulting company that has received research grants from Janssen Scientific Affairs,LLC, to conduct this study. Janssen Scientific Affairs, LLC – Consultant.

Patrick Lefebvre: Analysis Group, Inc. – Employee, Employee of Analysis Group, Inc., a consulting company that has received research grants from Janssen Scientific Affairs,LLC, to conduct this study. Janssen Scientific Affairs, LLC – Consultant.

Dominic Pilon, MA¹, Ruizhi Zhao, PhD², Ameur M. Manceur, PhD¹, Zhijie Ding, PhD, MS², Sumesh Kachroo, PhD², Maude Vermette-Laforme, BSc¹, Patrick Lefebvre, MA¹. D0371 - Non-Biologic Medication Use Pre- and Post-Ustekinumab Initiation Among Patients With Ulcerative Colitis, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.