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Observational Study
. 2024 Oct 3;30(10):1776-1787.
doi: 10.1093/ibd/izad245.

Real-World Persistence of Successive Biologics in Patients With Inflammatory Bowel Disease: Findings From ROTARY

Noa Krugliak Cleveland  1 , Sabyasachi Ghosh  2 , Benjamin Chastek  3 , Tim Bancroft  3 , Ninfa Candela  2 , Tao Fan  2 , Kandavadivu Umashankar  2 , David T Rubin  1
Affiliations
Observational Study

Real-World Persistence of Successive Biologics in Patients With Inflammatory Bowel Disease: Findings From ROTARY

Noa Krugliak Cleveland et al. Inflamm Bowel Dis. .

Abstract

Background: Patients with inflammatory bowel disease (IBD) may receive multiple successive biologic treatments in clinical practice; however, data are limited on the comparative effectiveness of biologics and the impact of treatment sequence on outcomes.

Methods: The ROTARY (Real wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) study was a retrospective, observational cohort study conducted using data from the Optum Clinical Database between January 1, 2012, and February 29, 2020. Adult patients with Crohn's disease (CD) or ulcerative colitis (UC) who received 2 biologics successively were included. Biologic treatment sequences were analyzed descriptively. Cox proportional hazards models, adjusted for baseline demographics and clinical characteristics, were used to estimate the hazard ratio of switching or discontinuation for each first- and second-line biologic compared with first- and second-line adalimumab, respectively.

Results: In total, 4648 patients with IBD (CD, n = 3008; UC, n = 1640) were identified. Most patients received tumor necrosis factor α antagonist (anti-TNFα) treatment followed by another anti-TNFα treatment or vedolizumab. Vedolizumab and infliximab had 39.4% and 34.6% lower rates of switching or discontinuation than adalimumab, respectively, as first-line biologics in patients with CD and 30.8% and 34.3% lower rates as first-line biologics in patients with UC, respectively. Vedolizumab, infliximab, and ustekinumab had 47.2%, 40.0%, and 43.5% lower rates of switching or discontinuation than adalimumab, respectively, as second-line biologics in CD and 56.5%, 43.0%, and 45.6% lower rates as second-line biologics in patients with UC, respectively.

Conclusions: Although anti-TNFα treatments were most commonly prescribed, the adjusted rates of discontinuation for adalimumab as both a first- and second-line biologic were higher than for vedolizumab, infliximab, or ustekinumab.

Keywords: Crohn’s disease; biologics; inflammatory bowel disease; sequencing; ulcerative colitis.

Plain language summary

Patients with inflammatory bowel disease are commonly treated with different sequences of biologics. This study shows that patients who receive adalimumab as their first or second biologic treatment either stop or switch to another biologic at a greater rate than those who are treated with vedolizumab, infliximab, and ustekinumab.

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Conflict of interest statement

N.K.C. has served as a consultant for NeuroLogica and Takeda Pharmaceuticals USA, Inc. and received speaker's fees from Bristol Myers Squibb. B.C. and T.B. are employees of Optum. S.G. was an employee of Takeda Pharmaceuticals USA, Inc at the time of the study and had stock or stock options. N.C. and T.F. are employees of Takeda Pharmaceuticals USA, Inc and have stock or stock options. K.U. was an employee of University of Illinois, Chicago, IL, USA, supported by a Takeda Pharmaceuticals USA, Inc fellowship at the time of the study. D.T.R. has received grant support from Takeda Pharmaceuticals USA, Inc. and served as a consultant for AbbVie, AltruBio, Arena Pharmaceuticals, Bristol Myers Squibb, Genentech/Roche, Gilead Sciences, Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Prometheus Biosciences, Takeda, and TechLab Inc.

Figures

Graphical Abstract
Graphical Abstract
Figure 1.
Figure 1.
Biologic treatment sequences in patients with (A) Crohn's disease and (B) ulcerative colitis. ADA, adalimumab, IFX, infliximab, UST, ustekinumab; VDZ, vedolizumab.
Figure 2.
Figure 2.
Time to switching, discontinuation, or the end of study period in (A) Crohn's disease: first line, (B) Crohn's disease: second line, (C) ulcerative colitis: first line, and (D) ulcerative colitis: second line. ADA, adalimumab; CI, confidence interval; IFX, infliximab; UST, ustekinumab; VDZ, vedolizumab.
Figure 3.
Figure 3.
Adjusted rate of switching or discontinuation of first- and second-line biologics. aBonferroni adjusted. Abbreviations: ADA, adalimumab; CI, confidence interval; IFX, infliximab; NA, not applicable; UST, ustekinumab; VDZ, vedolizumab.
See this image and copyright information in PMC

References

    1. Kornbluth A, Sachar DB.. Ulcerative colitis practice guidelines in adults: American college of gastroenterology, practice parameters committee. Am J Gastroenterol. 2010;105(3):501-23; quiz 524. - PubMed
    1. Ordás I, Eckmann L, Talamini M, Baumgart DC, Sandborn WJ.. Ulcerative colitis. Lancet. 2012;380(9853):1606-1619. - PubMed
    1. Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel J-F.. Ulcerative colitis. Lancet. 2017;389(10080):1756-1770.? - PMC - PubMed
    1. Roda G, Chien Ng S, Kotze PG, et al. . Crohn’s disease. Nat Rev Dis Primers. 2020;6(1):22. - PubMed
    1. Sulz MC, Burri E, Michetti P, Rogler G, Peyrin-Biroulet L, Seibold F; on behalf of the Swiss IBDnet, an official working group of the Swiss Society of Gastroenterology. Treatment algorithms for Crohn’s disease. Digestion. 2020;101(Suppl 1):43-57. - PubMed

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