D0370 - Persistence Among Patients With Crohn’s Disease Previously Treated With an Anti-tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent

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

Introduction: Among patients with Crohn’s disease (CD), non-response to an anti-TNF agent can lead to switching to a biologic in a different class (i.e., ustekinumab, vedolizumab) or cycling to another anti-TNF agent (i.e., adalimumab, infliximab, certolizumab). This study compared real-world persistence among patients with CD who switch or cycle from an anti-TNF agent.

Methods: Adults with CD treated with an anti-TNF whose first switching or cycling (index date) occurred between 09/23/2016 and 08/01/2019 were selected from the IBM® MarketScan® Commercial Database. Patients had: ≥12 months of continuous insurance eligibility before the first anti-TNF, discontinuation of the first anti-TNF within 12 months (baseline period) of the index date, and no other immune disorders in the 12-month baseline period. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights (IPTW). Persistence to index biologic (i.e., biologic switched or cycled to) was defined as absence of therapy exposure gaps >120 days (ustekinumab, vedolizumab, infliximab) or >60 days (adalimumab, certolizumab) between days of supply. Composite endpoints were: persistence and being corticosteroid-free (no corticosteroids with ≥14 days of supply after day 90 post-index), and persistence while on monotherapy (no immunomodulators/non-index biologics). Weighted Kaplan-Meier and Cox models were used to assess outcomes at 12 months post-index.

Results: After IPTW, the sample size was 444 and 441 in the switching and cycling cohorts, and baseline characteristics were well balanced (Table 1). At 12 months post-index, the proportions of patients persistent to the index agent and patients persistent while on-monotherapy were significantly higher in the switching compared to the cycling cohort (Figure 1). In the switching compared to the cycling cohort, the rate of being persistent to the index agent was 44% higher (hazard ratio [HR]: 1.44; 95% confidence interval [CI]: 1.11-1.88; P=0.007*), the rate of being persistent and corticosteroid-free 8% higher (HR: 1.08; 95% CI: 0.89-1.32; P=0.426), and the rate of being persistent while on-monotherapy 56% higher (HR: 1.56; 95% CI: 1.28-1.90; P< 0.001*).

Discussion: Following the discontinuation of the first anti-TNF agent, patients with CD who switched to a different class of biologic were more persistent than patients who cycled to another anti-TNF agent. These findings may aid physicians whose patients experience loss of response on the first anti-TNF agent.

Figure: CD: Crohn’s disease; Std diff: standardized difference; SD: standard deviation; TNF: tumor necrosis factor; 5-ASA: 5-aminosalicylic acid

Table 1. Selected baseline characteristics in weighted switching and cycling cohorts1,2. Notes: (1) cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%; (2) patients receiving immunomodulators or corticosteroids (at least one episode of ≥90 days of continuous use), patients with CD-related hospitalizations or CD-related surgeries.

mean ± SD or n (%)	Switching N=444		Cycling N=441		Std diff (%)

Age	40.4	± 14.2	39.5	± 13.9	6.3
Female	250	(56.3%)	257	(58.4%)	4.3
All-cause costs (US$ 2021)	72,594	± 52,331	71,643	± 53,192	1.8
Prescription drug costs	35,134	± 29,132	34,340	± 30,674	2.7
Total medical costs	37,459	± 51,598	37,303	± 52,046	0.3
Claims-derived CD severity indicator²	263	(59.1%)	266	(60.5%)	2.7
Charlson Comorbidity Index	0.54	± 0.9	0.52	± 0.9	1.4
CD-related surgery	38	(8.6%)	37	(8.4%)	0.9
Medication
Corticosteroids	343	(77.1%)	331	(75.0%)	4.8
≥1 episode with ≥60 days of continuous corticosteroid use	137	(30.9%)	144	(32.7%)	3.9
5-ASA	150	(33.7%)	138	(31.3%)	5.1
Immunomodulators	149	(33.5%)	154	(34.9%)	2.9
Antidiarrheals	26	(5.8%)	27	(6.0%)	0.9
Baseline anti-TNF
Adalimumab	288	(64.9%)	278	(63.1%)	3.7
Infliximab	140	(31.4%)	148	(33.5%)	4.4
Certolizumab pegol	16	(3.7%)	15	(3.4%)	1.6

Table: CD: Crohn’s disease; Std diff: standardized difference; SD: standard deviation; TNF: tumor necrosis factor; 5-ASA: 5-aminosalicylic acid

Table 1. Selected baseline characteristics in weighted switching and cycling cohorts1,2. Notes: (1) 1. Cohorts were weighted on baseline characteristics using inverse probability of treatment weights; characteristics considered well balanced if standardized difference is <10%; (2) Patients receiving immunomodulators or corticosteroids (at least one episode of ≥90 days of continuous use), patients with CD-related hospitalizations or CD-related surgeries

Disclosures:

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

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).

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.

Bridget Goodwin: Janssen Pharmaceutical Companies of Johnson and Johnson – 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, Sumesh Kachroo, PhD², Ameur M. Manceur, PhD¹, Zhijie Ding, PhD, MS², Christopher Holiday, MA¹, Ruizhi Zhao, PhD², Bridget Goodwin, MD², Dominic Pilon, MA¹. D0370 - Persistence Among Patients With Crohn’s Disease Previously Treated With an Anti-tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.