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OTH-12 Efficacy and safety of vedolizumab subcutaneous formulation for ulcerative colitis: results of the visible trial
  1. WJ Sandborn1,
  2. F Baert2,
  3. S Danese3,
  4. Z Krznarić4,
  5. G D’Haens5,
  6. T Kobayashi6,
  7. X Yao7,
  8. J Chen7,
  9. K Kisfalvi7,
  10. S Vermeire2
  1. 1University of California San Diego USA
  2. 2University Hospitals Leuven, Belgium
  3. 3Humanitas University, Milan, Italy
  4. 4Clinical Hospital Centre Zagreb, Croatia
  5. 5Academic Medical Centre, Amsterdam, Netherlands
  6. 6Kitasato University Kitasato Institute Hospital, Tokyo, Japan
  7. 7Takeda Development Center Americas Inc., Cambridge, USA


Introduction Vedolizumab, a gut-selective, humanised, monoclonal α4b7 integrin antibody, is available as an intravenous (IV) formulation to adult patients (pts) with moderately to severely active ulcerative colitis (UC) or Crohn’s disease. We present the phase 3 results on a new subcutaneous (SC) formulation for maintenance treatment in UC.

Methods A randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial (NCT02611830) assessed vedolizumab SC as maintenance treatment in adult pts with active UC. An open-label induction with vedolizumab IV (300 mg) was administered at Weeks (Wks) 0 and 2, with disease evaluation at Wk 6. Pts with a clinical response at Wk 6 (complete Mayo score reduction of ≥3 points and ≥30% from baseline [Wk 0] plus reduction in rectal bleeding subscore of ≥1 point or absolute subscore of ≤1 point) were randomised (2:1:1) to receive vedolizumab SC (108 mg every 2 wks), or vedolizumab IV (300 mg every 8 wks) or placebo for up to 52 wks. The primary objective was to assess clinical remission (defined as complete Mayo score of ≤2 points and no individual subscore >1 point) with vedolizumab SC vs placebo at Wk 52. Between-group treatment effects were compared using the Cochran-Mantel-Haenszel test with stratification by study randomisation factors (concomitant corticosteroid use, Wk 6 remission status, and prior anti-TNFα failure or immunomodulator use).

Results A total of 383 pts received open-label vedolizumab IV induction. Of those, 216 (56.4%) experienced clinical response at Wk 6 and entered the maintenance phase. At Wk 52, 46.2% of pts on vedolizumab SC vs 14.3% on placebo were in clinical remission (p<0.001). Similarly, 42.6% of vedolizumab IV pts were in clinical remission at Wk 52. Subgroup analysis showed clinical remission rates were significantly higher with vedolizumab SC vs placebo in both anti-TNFα-naïve pts (vedolizumab 53.7% vs placebo 18.9%, p<0.001) and anti-TNFα-failure pts (vedolizumab 33.3% vs placebo 5.3%, p=0.023). Injection-site reactions were mild (9.4% vedolizumab SC vs 0% placebo pts) none leading to discontinuation. Adverse event (AE) rates, including severe AEs and infections, were similar in the vedolizumab SC and IV groups. The rate of anti-vedolizumab antibodies in the vedolizumab SC group was 5.7%, consistent with 5.6% for vedolizumab IV.

Conclusions Vedolizumab SC 108 mg every 2 wks was efficacious, generally safe and well-tolerated as maintenance therapy in UC pts following induction with vedolizumab IV 300 mg showing an efficacy and safety profile similar to that of the currently available IV formulation.

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