Real-World Treatment Outcomes Associated With Early Versus Delayed Vedolizumab Initiation in Patients With Ulcerative Colitis

Noa Krugliak Cleveland, Ninfa Candela*, John A. Carter, Maja Kuharic, Joyce Qian, Zhaoli Tang, Robin Turpin, David T. Rubin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Patients with ulcerative colitis (UC) typically receive a targeted inflammatory bowel disease therapy after treatment with conventional therapies and after the development of significant morbidity. Evidence suggests that early biologic treatment after diagnosis could improve treatment response and prevent disease complications compared with delayed biologic treatment after conventional therapy. Methods: RALEE was a retrospective study using claims data from IBM® MarketScan® Research Databases between January 1, 2016 and December 31, 2019. Adults with UC and at least one claim for vedolizumab were categorized into Early or Delayed Vedolizumab groups according to whether they had received vedolizumab within 30 days of diagnosis or after conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators), respectively. Treatment response was assessed at 2, 6, and 12 months after vedolizumab treatment initiation and was analyzed with logistic regression (bivariate). Results: At 2 months, Delayed Vedolizumab was associated with significantly higher odds of nonresponse than Early Vedolizumab (odds ratio [OR], 2.509; 95% confidence interval [CI], 1.28-4.90). Delayed Vedolizumab was not significantly associated with odds of nonresponse at 6 months (OR, 1.173; 95% CI, 0.72-1.90) or at 12 months (OR, 0.872; 95% CI, 0.55-1.37). Mean total healthcare costs were similar in the Early Vedolizumab ($6492) and Delayed Vedolizumab ($5897) groups, although there were small differences in costs from different types of claims. Conclusions: Patients who received vedolizumab early after UC diagnosis were less likely to experience nonresponse at 2 months and incurred similar healthcare costs at 12 months compared with patients who received delayed vedolizumab.

Original languageEnglish (US)
Article numberotae061
JournalCrohn's and Colitis 360
Volume6
Issue number4
DOIs
StatePublished - Oct 1 2024

Funding

This study was funded by Takeda Pharmaceuticals USA, Inc. N.K.C. serves as a consultant for NeuroLogica and Takeda Pharmaceuticals USA, Inc. and serves as a speaker for Bristol Myers Squibb. N.C. is an employee of Takeda Pharmaceuticals USA, Inc. and has stock or stock options. J.A.C., J.Q., and Z.T. are employees of OPEN Health, a research consultancy that received fees from Takeda Pharmaceuticals USA, Inc. to conduct these analyses. M.K. is an employee of the University of Illinois Chicago, College of Pharmacy, supported by a Takeda Pharmaceuticals USA, Inc. fellowship at the time of the study. R.T. is a former employee of Takeda Pharmaceuticals USA, Inc. and has stock or stock options. D.T.R. has received grant support from Takeda Pharmaceuticals USA, Inc. and has served as a consultant for AbbVie, AltruBio, Arena Pharmaceuticals, Bristol Myers Squibb, Genentech/Roche, Gilead Sciences, Inc., Iterative Scopes, Janssen Pharmaceuticals, Lilly, Pfizer, Prometheus Biosciences, Takeda, and TechLab Inc.

Keywords

  • early treatment
  • inflammatory bowel disease
  • treatment sequence
  • ulcerative colitis
  • vedolizumab

ASJC Scopus subject areas

  • Gastroenterology

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