Vedolizumab and Adalimumab in Biologic-Naïve Ulcerative Colitis: Comparison of Patient-Level Clinical Trial Data and VARSITY for Week 6 Clinical Remission

Neeraj Narula*, Emily C.L. Wong, Parambir S. Dulai, John K. Marshall, Vipul Jairath, Walter Reinisch

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Indirect treatment comparisons using patient-level data are increasing in popularity within inflammatory bowel disease research. We compared the efficacy of adalimumab and vedolizumab for biologic-naïve moderate–severe ulcerative colitis (UC) using indirect comparisons of phase 3 clinical trials and compared the results to the RCT VARSITY. Design: Pooled analysis of patient-level data from 518 biologic-naïve patients with UC was performed using GEMINI-1 and ULTRA-1. Proportions of patients achieving week 6 clinical remission and clinical response were compared, and propensity score matching and multivariate logistic regression were used to account for potential confounders. These results were compared to those derived from VARSITY. Results: A numerically greater proportion of vedolizumab-treated patients from GEMINI-1 achieved week 6 clinical remission compared to those treated with adalimumab [136/388 (35.1%) vs. 38/130 (29.2%)]. Similar findings were observed among the propensity score matched cohort [33/110 (30.0%) vs. 25/110 (22.7%), adjusted OR (aOR) 1.56 (95% confidence interval (CI) 0.81–3.02), p = 0.187]. A similar magnitude for absolute difference in the proportions of patients achieving week 6 clinical remission was observed from VARSITY in vedolizumab compared to adalimumab [131/305 (43.0%) vs. 114/307 (37.1%), OR 1.27 (95% CI 0.92–1.76), p = 0.142]. Conclusions: In this post hoc analysis, a similar magnitude in the absolute difference of efficacy at week 6 among biologic-naïve patients was observed using indirect comparisons of phase 3 clinical trial data as was observed in VARSITY. Indirect comparisons using patient-level clinical trial data could be used to inform drug choices for future head-to-head trials and guide positioning of drugs in the absence of head-to-head trials.

Original languageEnglish (US)
Pages (from-to)2658-2666
Number of pages9
JournalDigestive diseases and sciences
Volume68
Issue number6
DOIs
StatePublished - Jun 2023

Keywords

  • Biologics
  • Comparative effectiveness
  • Inflammatory bowel disease
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology
  • Physiology

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