P0789 - Persistence Among Patients with Ulcerative Colitis Previously Treated with an Anti-Tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

SK

Sumesh Kachroo, PhD

Janssen Scientific Affairs, LLC
Horsham, Pennsylvania

Maryia Zhdanava, MA¹, Sumesh Kachroo, PhD², Paul Boonmak, MD, MPHS, PhD¹, Sabree Burbage, PharmD, MPH², Samuel Schwartzbein, MA¹, Bridget Godwin, MD², Patrick Lefebvre, MA¹, Dominic Pilon, MA¹
¹Analysis Group, Inc., Montreal, PQ, Canada; ²Janssen Scientific Affairs, LLC, Horsham, PA

Introduction: In ulcerative colitis (UC), anti-TNF agents often are first-line biologic therapy. Switching to a different class of biologics (ustekinumab, vedolizumab) or cycling to another anti-TNF agent (adalimumab, infliximab, golimumab) is necessary if an initial anti-TNF fails. Real-world persistence in patients with UC who switch or cycle from an anti-TNF agent was compared.

Methods: Adults with UC treated with an anti-TNF, who switched or cycled (index date) between 10/21/2019 and 03/02/2022, were selected from the IQVIA PharMetrics^®Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti-TNF without UC-indicated biologics or advanced therapies. During the 12-months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti-TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on index biologic was defined as no therapy exposure gaps >120 days (ustekinumab, vedolizumab, infliximab) or >60 days (adalimumab, golimumab) between days of supply. Composite endpoints were persistence and being corticosteroid-free (< 14 consecutive days of corticosteroids supply after day 90 post-index), and persistence while on monotherapy (no immunomodulators/non-index biologics/advanced therapies). Endpoints were assessed with weighted Kaplan-Meier and Cox proportional hazards models at 12 months after maintenance phase start.

Results: The switch and cycle cohorts included 488 and 129 patients, respectively; baseline characteristics were well balanced (Table 1). At 12 months after maintenance phase start, proportions of persistent patients and patients persistent on monotherapy were significantly higher in the switch versus the cycle cohort (Figure 1). In the switch cohort, the rate of persistence was 53% higher (hazard ratio [HR]: 1.53; 95% confidence interval [CI]: 1.10-2.12), the rate of persistence and being corticosteroid-free 23% higher (HR: 1.23; 95% CI: 0.93-1.63), and the rate of persistence while on-monotherapy was two times higher (HR: 2.18; 95% CI: 1.64-2.92) than in the cycle cohort.

Discussion: Patients with UC who switched from an anti-TNF agent to a different class of biologic were more persistent than patients who cycled to another anti-TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti-TNF agent.

Funded by Janssen Scientific Affairs, LLC

Figure: Figure 1. Kaplan-Meier curves in weighted* switch and cycle cohorts of being: a) persistent to index biologic, b) persistent and corticosteroid-free, c) persistent while on monotherapy. *Cohorts were weighted on baseline characteristics using inverse probability of treatment weights.

Mean ± SD [median] or n (%)	Switch N=488	Cycle N=129	Std diff (%)
Age (years)	41.4 ± 13.9 [40.8]	40.7 ± 12.6 [40.2]	5.4
Female	219 (44.9)	57 (43.8)	2.1
Any intestinal complication	71 (14.5)	22 (17.3)	7.8
Selected general comorbid condition
Diarrhea	269 (55.2)	73 (56.8)	3.2
Pain	219 (44.8)	60 (46.2)	2.8
Anemia	164 (33.6)	40 (31.2)	5.2
UC-related medication
Baseline anti-TNF
Adalimumab	295 (60.5)	73 (56.9)	7.5
Infliximab and biosimilars	188 (38.6)	56 (43.1)	9.2
Golimumab	4 (0.8)	0 (0.0)	12.9*
Corticosteroids	387 (79.4)	98 (75.8)	8.7
5-ASA	324 (66.3)	80 (62.2)	8.5
Immunomodulators	84 (17.2)	21 (16.4)	2.1
Antidiarrheals	28 (5.8)	6 (4.4)	6.4
Concomitant medication
Opioids	166 (34.1)	43 (33.2)	1.9
Antibiotics	139 (28.6)	38 (29.2)	1.5
All-cause costs (US$ 2022)	62,103 ± 46,224 [54,686]	60,596 ± 35,758 [57,779]	3.7
Prescription drug costs	37,478 ± 35,277 [35,119]	37,298 ± 34,639 [29,749]	0.5
Medical costs	24,626 ± 40,172 [13,650]	23,298 ± 27,065 [13,113]	3.9

Table: SD: standard deviation; Std diff: standardized difference; TNF: tumor necrosis factor; UC: ulcerative colitis; 5-ASA: 5-aminosalicylic acid
*denotes standardized difference ≥10%.
Table 1. Selected baseline characteristics in weighted switch and cycle cohorts**. **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 – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..

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

Paul Boonmak: Analysis Group, Inc. – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..

Sabree Burbage: Janssen Scientific Affairs, LLC – Employee.

Samuel Schwartzbein: Analysis Group, Inc – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..

Bridget Godwin: Janssen Research & Development, LLC – Employee. Johnson & Johnson – Stock-publicly held company(excluding mutual/index funds).

Patrick Lefebvre: Acadia Pharmaceuticals – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Acadia Pharmaceuticals. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC.. Myovant Sciences – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Myovant Sciences.. Novartis – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Novartis.. Otsuka – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Otsuka.. Pharmacyclics – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Pharmacyclics..

Dominic Pilon: Analysis Group, Inc – Employee. Janssen Scientific Affairs, LLC – I am an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC..

Maryia Zhdanava, MA¹, Sumesh Kachroo, PhD², Paul Boonmak, MD, MPHS, PhD¹, Sabree Burbage, PharmD, MPH², Samuel Schwartzbein, MA¹, Bridget Godwin, MD², Patrick Lefebvre, MA¹, Dominic Pilon, MA¹. P0789 - Persistence Among Patients with Ulcerative Colitis Previously Treated with an Anti-Tumor Necrosis Factor Inhibitor and Switching or Cycling to Another Biologic Agent, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.