Reductions in Corticosteroid Use in Patients with Ulcerative Colitis or Crohnʼs Disease Treated with Vedolizumab

Abstract

Purpose: Long-term corticosteroid use in ulcerative colitis (UC) and Crohn's disease (CD) leads to adverse effects/dependence. The effect of vedolizumab (VDZ), an anti-α4β7 integrin antibody, on corticosteroid reduction has been studied in UC and CD patients (pts). Methods: In two phase 3 studies (GEMINI I [UC] and II [CD]), pts received placebo (PB) or VDZ 300 mg intravenously during induction (weeks 0 and 2) and maintenance (weeks 6-52, every 8 or 4 weeks [Q8W/Q4W]). Pts on corticosteroids at week 0 with a clinical response at week 6 began corticosteroid tapering at week 6. Week 52 corticosteroid-free remission rates (prespecified) and associations between week 6 end points and week 52 corticosteroid-free remission (post hoc) were assessed. Results: In the UC trial, VDZ Q8W and Q4W led to significantly greater week 52 corticosteroid-free remission rates and decreased corticosteroid use for up to 180 d than did PB. Of pts in week 6 remission, significantly more in the VDZ Q4W group than the PB group had corticosteroid-free week 52 remission. In pts with week 6 mucosal healing, week 52 corticosteroid-free remission rates were significantly higher with VDZ Q8W and Q4W than PB. In the CD trial, VDZ also led to significantly greater week 52 corticosteroid-free remission rates (Q8W, Q4W) and decreased corticosteroid use for up to 180 d (Q8W) than did PB. In CD pts in week 6 clinical remission, no significant differences from PB in VDZ week 52 corticosteroid-free remission rates were seen. Conclusion: VDZ treatment led to corticosteroid-free remission in UC and CD patients. Future studies are needed to confirm whether 6-week clinical remissions and/or mucosal healing are predictive of 52-week steroid-free remissions. This research was funded by Millennium Pharmaceuticals, Inc., a Takeda Company, Cambridge, MA. Disclosure - B. Sands - Financial support for research from: Takeda Pharmaceuticals, Abbott Immunology, Janssen Biotech, Celgene, Pfizer, UCB, GlaxoSmithKline, Prometheus Laboratories, Lecture fee(s) from: Mechanisms in Medicine, Creative Educational Concepts, Curatio CME, IMEDEX, Consultancy for: Takeda Pharmaceuticals, Abbott Immunology, Amgen, Astellas Pharmaceutical Global Development, Avaxia Biologics, Axcan Pharmaceuticals, Biogen Idec, Bristol-Myers Squibb, Janssen Biotech, Chandler Chicco Agency, Cornerstones, Emmi Solutions, Elan Pharmaceuticals, Merrimack Pharmaceuticals, Pfizer, Prometheus Laboratories, Kyowa Hakko Kirin Pharma Inc, Vertex Pharmaceuticals, Strategic Consultants International, Dyax, GlaxoSmithKline, Puretech Ventures, Novartis, Baxter Healthcare Corporation, Dainippon Sumitomo Pharm Co, Immune Pharmaceuticals Corporation, Teva Pharmaceuticals, Shareholder of: Avaxia Biologics; S. Hanauer - Financial support for research from: Millennium Pharmaceuticals, Consultancy for: Takeda Pharmaceuticals, Millennium Pharmaceuticals; J.-F. Colombel - Financial support for research from: Ferring, MSD, Abbott Laboratories, Lecture fee(s) from: Abbott Laboratories, Centocor, Ferring, Given Imaging, Shire, MSD, UCB Pharmaceuticals, Tillotts, Consultancy for: Takeda Pharmaceuticals, Abbott Laboratories, Amgen, Biogen Idec Inc, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix SL, Chemocentryx Inc, Centocor, Cosmo Technologies, Elan Pharmaceuticals, Genentech, Giuliani, Given Imaging, GlaxoSmithKline, Hospira, Immune Pharmaceuticals, MSD, Neovacs, Ocera Therapeutics, Pfizer, Prometheus, Shire Pharmaceuticals, Synta Pharmaceuticals, Teva Pharmaceuticals, Therakos, UCB Pharmaceuticals, TXCell, Wyeth, Shareholder of: Intestinal Biotech Development, Other: Takeda Pharmaceuticals, Schering-Plough; S. Danese - Lecture fee(s) from: Vifor Pharma, MSD, Consultancy for: Ferring, Takeda Pharmaceuticals, Abbott, MSD, Vifor Pharma, Novo Nordisk, AstraZeneca, UCB, Pfizer; M. Abreu - Consultancy for: Abbott Laboratories, Bristol-Myers Squibb, Hospira, Merck, Pfizer, Sanofi-Aventis, UCB; V. Ahuja - None Declared; T. Ponich - None Declared; I. Hilmi - None Declared; S. Sankoh - Employee: Millennium Pharmaceuticals; M. Smyth - Shareholder of: Takeda Global Research & Development Centre, Employee: Takeda Global Research & Development Centre, B. Abhyankar - Shareholder of: Takeda Global Research & Development Centre, Employee: Takeda Global Research & Development Centre; I. Fox - Shareholder of: Millennium Pharmaceuticals, Employee: Millennium Pharmaceuticals; B. Feagan - Financial support for research from: Takeda Pharmaceuticals, Lecture fee(s) from: Johnson and Johnson, Abbott Laboratories, UCB, Shire, Consultancy for: Takeda Pharmaceuticals, Johnson and Johnson, Centocor, Elan/Biogen, Bristol-Myers Squibb, Celgene, CombinatoRx, UCB Pharma, Napo Pharma, Abbott Laboratories, Procter and Gamble, Berlex, Ore Pharmaceuticals, Cerimon Pharma, Genentech, Tillotts, Unity Pharmaceuticals, Albireo Pharma, Salix Pharma, Novo Nordisk, GSK, Astra Zeneca, Serono, Given Imaging Inc, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Nektar, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GICare Pharma, Sigmoid Pharma. This research was supported by an industry grant from Millennium Pharmaceuticals, Inc, a Takeda Company.Table