EFFECT OF VEDOLIZUMAB ON SURGICAL RATES IN IBD: POST HOC ANALYSIS FROM THE GEMINI TRIALS

Background: Vedolizumab (VDZ) is a safe and effective treatment for moderately to severely active ulcerative colitis and Crohn's disease; however, effects on surgical rates have not yet been evaluated. This study aimed (1) to compare the surgical incidence rates of VDZ and placebo in GEMINI I (ulcerative colitis; NCT00783718) and II (Crohn's disease; NCT00783692) and (2) to describe the surgical incidence rates through year 5 from the GEMINI LTS trial (ulcerative colitis and Crohn's disease; NCT00790933). Methods: Data were pooled from week 6 induction VDZ responders who were randomized to VDZ or placebo maintenance (intent-to-treat maintenance populations) from GEMINI I1 and II,2 and from patients receiving VDZ in the GEMINI LTS trial.3,4 Using the Kaplan-Meier product-limit method, we estimated “time to first surgery” through 1 year (VDZ and placebo groups from GEMINI I and II) and 5 years (VDZ1 and VDZ2 groups from GEMINI LTS [VDZ1=VDZ throughout; VDZ2=placebo from week 6 to 1 year, then VDZ for the LTS study]). Patients without surgery were censored at the last follow-up date through 1 year and 5 years. The log-rank test was used for comparisons between groups. Results: The analysis included 834 patients in total. Mean ages were 40.0 and 35.7 years for patients with ulcerative colitis and Crohn's disease, respectively; proportions of prior tumor necrosis factor antagonist failure were 39.9% and 54.9%, and mean disease duration times were 7.2 and 8.6 years. Figure 1 shows cumulative surgical incidence rates for the study groups, as well as the log-rank comparisons at 1 year (VDZ and placebo groups) and 5 years (VDZ1 and VDZ2 groups). Conclusion: In this population of patients with moderately to severely active ulcerative colitis or Crohn's disease, surgery rates within the first year of observation were lower in patients assigned to VDZ than in those who received placebo, with a significant difference observed in ulcerative colitis. For patients who continued treatment for up to 5 years, VDZ provided long-term benefit in both diseases with low rates of surgical intervention. The post hoc nature of the analysis and the small number of surgical events require further real-world evaluation of the ability of VDZ to reduce surgical rates in patients with ulcerative colitis and Crohn's disease. References 1Feagan BG, et al. N Engl J Med. 2013;369:699-710 2Sandborn WJ, et al. N Engl J Med. 2013;369:711-21 3Loftus EV Jr, et al. J Crohns Colitis. 2017;11:400-11 4Vermeire S, et al. J Crohns Colitis. 2017;11:412-24 [Figure presented]