P2649 - Persistence of First and Second Lines of Biologic Treatment Across Different Treatment Sequences in Patients With Inflammatory Bowel Disease Receiving at Least Two Biologics: Findings from ROTARY-1

Tuesday, October 26, 2021

10:30 AM – 4:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Award: Presidential Poster Award

Presenting Author(s)

Noa Krugliak Cleveland, MD

University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL, United States

Award: Presidential Poster Award

Noa Krugliak Cleveland, MD¹, Benjamin Chastek, MS², Sabyasachi Ghosh, MS³, Ninfa Candela, MD⁴, Timothy Bancroft, PhD², Tao Fan, PhD, MS³, Kandavadivu Umashankar, PharmD, MS³, David T. Rubin, MD, FACG¹
¹University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; ²Optum Life Sciences, Inc, Eden Prairie, MN; ³Takeda Pharmaceuticals USA, Inc., Lexington, MA; ⁴Takeda Pharmaceuticals USA, Inc., Wellesley, MA

Introduction: Following inadequate response, loss of response, or intolerance to a first-line biologic, patients with inflammatory bowel disease (IBD) may discontinue treatment and subsequently receive a second-line biologic. Data on treatment persistence in these patients are limited but could provide insight into biologic treatment sequences and the real-world effectiveness and safety of second-line biologics.

Methods: ROTARY-1 (Real wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) used data from the Optum Clinical Database and included adult patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) who received at least two sequential biologics, with the first initiated between January 1, 2013 and February 29, 2020. Persistence was defined as the time from treatment initiation until discontinuation, with a gap of 60 days or more for adalimumab (ADA) and 120 days or more for infliximab (IFX), vedolizumab (VDZ), and ustekinumab (UST). Cox proportional hazards models, adjusting for baseline demographics and clinical characteristics, were used to estimate the rate of discontinuation for each first- and second-line biologic compared with first- and second-line ADA, respectively. Analyses were conducted separately for the CD and UC cohorts.

Results: Among 13,661 patients with CD who received a first-line biologic, 3008 (22.0%) received a second-line biologic (Table). As first-line biologics, VDZ, IFX, and UST had 39.4%, 34.6%, and 1.7% lower rate of discontinuation than ADA, respectively. As second-line biologics, VDZ, UST, and IFX had 47.2%, 43.5%, and 40.0% lower rate of discontinuation than ADA, respectively (Figure A).

Among 7123 patients with UC who received a first-line biologic, 1640 (23.0%) received a second-line biologic (Table). IFX and VDZ had 34.3% and 30.8% lower rate of discontinuation than ADA, respectively, as first-line biologics. As second-line biologics, VDZ, UST, and IFX had 56.5%, 45.6%, and 43.0% lower rate of discontinuation than ADA, respectively (Figure B).

Discussion: We describe real-world data of patients with IBD who received at least two sequential biologics. There were notable differences in persistence between therapies, favoring VDZ, IFX, and UST over ADA. For both CD and UC, VDZ received as a first- or second-line biologic had a lower rate of discontinuation than ADA. These data can inform treatment choice and positioning of biologic therapies in IBD.

Figure: Figure. Hazard ratios for rate of discontinuation for first- and second-line biologics in patients with (A) Crohn’s disease or (B) ulcerative colitis. ADA, adalimumab; CI, confidence interval; IFX, infliximab; NA, not available; UST, ustekinumab; VDZ, vedolizumab.

Biologic treatment sequence	Crohn’s disease (N = 3008)		Ulcerative colitis (N = 1640)
Biologic treatment sequence	n	%	n	%
ADA to IFX	637	21.2	330	20.1
ADA to VDZ	522	17.4	401	24.5
ADA to UST	446	14.8	33	2.0
IFX to ADA	454	15.1	266	16.2
IFX to VDZ	317	10.5	374	22.8
IFX to UST	185	6.2	21	1.3
VDZ to ADA	55	1.8	64	3.9
VDZ to IFX	56	1.9	119	7.3
VDZ to UST	218	7.2	30	1.8
UST to ADA	44	1.5	0	0.0
UST to IFX	27	0.9	1	0.1
UST to VDZ	47	1.6	1	0.1

Table: Table. Biologic treatment sequences in patients with Crohn’s disease or ulcerative colitis. ADA, adalimumab; IFX, infliximab; UST, ustekinumab; VDZ, vedolizumab.

Disclosures:

Noa Krugliak Cleveland: Takeda Pharmaceuticals U.S.A., Inc – Consultant.

Benjamin Chastek: Optum – Employee.

Sabyasachi Ghosh: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Ninfa Candela: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Timothy Bancroft: Optum – Employee, I am an employee of Optum. Optum was paid by Takeda for this work. My employment at Optum is not contingent upon this work..

Tao Fan: Takeda Pharmaceuticals U.S.A., Inc – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

Kandavadivu Umashankar: Takeda Pharmaceuticals U.S.A., Inc – Employee.

David Rubin: Takeda Pharmaceuticals U.S.A., Inc – Consultant.

Noa Krugliak Cleveland, MD¹, Benjamin Chastek, MS², Sabyasachi Ghosh, MS³, Ninfa Candela, MD⁴, Timothy Bancroft, PhD², Tao Fan, PhD, MS³, Kandavadivu Umashankar, PharmD, MS³, David T. Rubin, MD, FACG¹. P2649 - Persistence of First and Second Lines of Biologic Treatment Across Different Treatment Sequences in Patients With Inflammatory Bowel Disease Receiving at Least Two Biologics: Findings from ROTARY-1, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.