D0369 - Long-Term Persistence to Ustekinumab and Adalimumab Among Bio-Naïve Patients With Crohn's Disease

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

Maryia Zhdanava, MA¹, Zhijie Ding, PhD, MS², Ameur M. Manceur, PhD¹, Sumesh Kachroo, PhD², Christopher Holiday, MA¹, Ruizhi Zhao, PhD², James Izanec, MD², Dominic Pilon, MA¹
¹Analysis Group, Inc., Montreal, PQ, Canada; ²Janssen Scientific Affairs, LLC, Horsham, PA

Introduction: Persistence on biologics in Crohn’s disease (CD) is an important measure, reflecting real-world treatment effectiveness, safety, and other factors. In the real world among bio-naïve patients with CD, evidence of superior one-year persistence on newer biologics, such as ustekinumab, relative to adalimumab exists, however, an understanding of persistence beyond one year is lacking.

Methods: Adults with CD initiated on ustekinumab or adalimumab between 09/23/2016 (approval of ustekinumab for CD in the US) and 08/01/2019 were selected from IBM® MarketScan® Commercial Database. Patients without other CD-indicated biologics (bio-naive) and diagnoses for other autoimmune diseases in the 12 months pre-index date (baseline) were included. No minimal follow-up was imposed post-index date. Persistence on index agent was defined as absence of gaps >120 days (ustekinumab) or >60 days (adalimumab) between days of therapy supply. Composite endpoints of being persistent and corticosteroid-free (no corticosteroids with ≥14 days of supply after day 90 post-index) and persistent while on monotherapy (no immunomodulators or non-index biologics) were also assessed. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. All endpoints were estimated at 24 months post-index using weighted Kaplan-Meier and Cox's proportional hazards models.

Results: There were 671 and 2,975 patients in the ustekinumab and adalimumab cohorts, respectively, and the cohorts were well-balanced at baseline (Table 1). At 24 months post-index, a significantly higher proportion of patients in the ustekinumab versus adalimumab cohort was persistent on index agent, as well as persistent and corticosteroid-free and persistent while on-monotherapy (Figure 1). At 24 months in ustekinumab versus adalimumab cohort, the rate of being persistent on index agent was 66% higher (hazard ratio [HR]: 1.66; 95% confidence interval [CI]: 1.40-1.97), the rate of being persistent and corticosteroid-free 15% higher (HR: 1.15; 95% CI: 1.01-1.31), and the rate of being persistent while on-monotherapy 44% higher (HR: 1.44; 95% CI: 1.26-1.64).

Discussion: Bio-naïve patients with CD initiated on ustekinumab versus adalimumab were significantly more persistent, more persistent and corticosteroid-free, and also more persistent while on-monotherapy 24 months after treatment initiation. These results are consistent with those in our previous work at 12 months.

Figure: Figure 1. Kaplan-Meier curves of being: a) persistent on index biologic, b) persistent and corticosteroid-free following a 90 days grace period, c) persistent and on monotherapy in weighted ustekinumab and adalimumab cohorts1,2
Notes:
1. Cohorts were weighted on baseline characteristics using inverse probability of treatment weights
2. Rates and log-rank p-values provided at 24 months

mean ± SD or n (%)	Ustekinumab N=671		Adalimumab N=2,975		Std diff, %
Age	41.7	± 13.3	41.6	± 13.8	0.8
Female	371	(55.3%)	1,642	(55.2%)	0.2
All-cause costs (US$ 2020)	35,258	± 57,472	30,104	± 52,884	9.3
Prescription drug costs	5,095	± 11,691	5,029	± 18,564	0.4
Total medical costs	30,163	± 55,485	25,075	± 47,187	9.9
Charlson Comorbidity Index	0.60	± 1.2	0.61	± 1.1	0.8
CD-related surgery	57	(8.5%)	221	(7.4%)	4.0
Medication
Corticosteroids	440	(65.6%)	2,068	(69.5%)	8.4
≥1 episode with ≥60 days of continuous use	164	(24.4%)	736	(24.8%)	0.7
Immunomodulators	177	(26.4%)	797	(26.8%)	1.0
5-ASA	177	(26.4%)	795	(26.7%)	0.8
Antidiarrheals	51	(7.6%)	204	(6.9%)	2.8

Table: Table 1. Selected baseline characteristics in weighted1 ustekinumab and adalimumab cohorts

Abbreviations: CD: Crohn’s disease; Std diff: standardized difference; SD: standard deviation; 5-ASA: 5-aminosalicylic acid
Notes: (1) Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%

Disclosures:

Maryia Zhdanava: Analysis Group, Inc. – Employee. 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).

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.

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.

Christopher Holiday: 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.

James Izanec: Janssen Scientific Affairs – Employee, Stock-publicly held company(excluding mutual/index funds).

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.

Maryia Zhdanava, MA¹, Zhijie Ding, PhD, MS², Ameur M. Manceur, PhD¹, Sumesh Kachroo, PhD², Christopher Holiday, MA¹, Ruizhi Zhao, PhD², James Izanec, MD², Dominic Pilon, MA¹. D0369 - Long-Term Persistence to Ustekinumab and Adalimumab Among Bio-Naïve Patients With Crohn's Disease, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.