P0788 - Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab

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, Aditi Shah, MA¹, Sabree Burbage, PharmD, MPH², Jill Korsiak, PhD¹, Patrick Lefebvre, MA¹, Lilian Diaz, MSc¹, Caroline Kerner, MD, MS², Dominic Pilon, MA¹
¹Analysis Group, Inc., Montreal, PQ, Canada; ²Janssen Scientific Affairs, LLC, Horsham, PA

Introduction: Therapy persistence is a useful measure of real-world therapy performance, including effectiveness and safety. Biologics are used for management of moderate-to-severe ulcerative colitis (UC). This study aimed to compare treatment persistence among bio-naïve patients with UC initiated on ustekinumab or adalimumab.

Methods: Adults with UC initiated on ustekinumab or adalimumab (index date) between 10/21/2019 and 03/02/2022 were selected from the IQVIA PharMetrics^® Plus database. Patients were excluded if, during the 12-month baseline period before the index date, they used other UC-indicated biologics/advanced therapies or had other immune conditions. Cohorts were balanced on baseline characteristics using inverse probability of treatment weights. Persistence was defined as absence of gaps >120 days (ustekinumab) or >60 days (adalimumab) between days of therapy supply. Additionally, composite endpoints of being persistent and corticosteroid-free (< 14 consecutive days of corticosteroid supply after day 90 post-index) and persistent and on monotherapy (no immunomodulators, non-index biologics, or advanced therapies) were assessed. All endpoints were estimated during maintenance phase until earlier of 12 months follow-up, end of insurance eligibility or end of data using weighted Kaplan-Meier and Cox proportional hazards models.

Results: There were 371 and 1,726 patients in the ustekinumab and adalimumab cohorts, respectively. Baseline characteristics were balanced in weighted cohorts (Table 1). At 12 months of maintenance phase, a higher proportion of patients initiated on ustekinumab compared to adalimumab were persistent on index biologic, including persistent and corticosteroid-free, and persistent and on monotherapy (Figure 1; log-rank p-values< 0.001). Patients initiated on ustekinumab had a 77% higher rate of persistence (hazard ratio [HR] 1.77; 95% confidence interval [CI]: 1.44-2.18), 58% higher rate of persistence while being corticosteroid-free (HR: 1.58; 95% CI: 1.33-1.88), and 80% higher rate of persistence while on monotherapy (HR: 1.80; 95% CI: 1.48-2.18) than those initiated on adalimumab.

Discussion: Bio-naïve patients with UC treated with ustekinumab were more persistent, including persistent while corticosteroid-free and persistent while on monotherapy, than patients treated with adalimumab. These findings may aid healthcare providers in choosing a biologic for bio-naïve patients with UC.
Funded by Janssen Scientific Affairs, LLC

Figure: Figure 1: Kaplan-Meier curves of being: a) persistent on index biologic, b) persistent and corticosteroid-free, c) persistent and on monotherapy in weighted* ustekinumab and adalimumab cohorts.

*Cohorts were weighted on baseline characteristics using inverse probability of treatment weights.

Mean ± SD [median] or n (%)	Ustekinumab N=371	Adalimumab N=1,726	Std diff (%)
Age (years)	42.0 ± 13.5 [42.1]	42.2 ± 13.9 [41.5]	0.8
Female	178 (48.1)	823 (47.7)	0.8
Any intestinal complication	59 (15.9)	239 (13.8)	5.8
Selected general comorbid condition
Diarrhea	182 (49.1)	883 (51.2)	4.1
Pain	166 (44.8)	765 (44.3)	1.0
Anemia	103 (27.7)	451 (26.1)	3.5
UC-related medication
Corticosteroids	283 (76.4)	1,343 (77.8)	3.5
5-ASA	284 (76.5)	1,320 (76.5)	0.1
Immunomodulators	45 (12.2)	226 (13.1)	2.9
Antidiarrheals	17 (4.7)	73 (4.2)	2.2
Concomitant medication
Opioids	115 (31.0)	559 (32.4)	2.9
Antibiotics	97 (26.0)	489 (28.3)	5.2
All-cause costs (US$ 2022)	18,702 ± 35,981 [10,942]	16,889 ± 27,018 [10,420]	5.7
Pharmacy costs	5,912 ± 16,753 [3,126]	5,216 ± 9,011 [3,366]	5.2
Medical costs	12,790 ± 30,399 [5,629]	11,672 ± 25,146 [5,009]	4.0

Table: 5-ASA: 5-aminosalicylic acid; SD: standard deviation; Std diff: standardized difference; UC: ulcerative colitis; US: United States.

Table 1. Selected baseline characteristics in weighted ustekinumab and adalimumab 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.

Aditi Shah: 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..

Sabree Burbage: Janssen Scientific Affairs, LLC – Employee.

Jill Korsiak: 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..

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..

Lilian Diaz: 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..

Caroline Kerner: Janssen Scientific Affairs, LLC – Employee. Johnson and Johnson, Inc – Stock Options.

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, Aditi Shah, MA¹, Sabree Burbage, PharmD, MPH², Jill Korsiak, PhD¹, Patrick Lefebvre, MA¹, Lilian Diaz, MSc¹, Caroline Kerner, MD, MS², Dominic Pilon, MA¹. P0788 - Real-World Treatment Persistence Among Bio-Naïve Patients With Ulcerative Colitis Initiated on Ustekinumab or Adalimumab, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.