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P566 Efficacy and safety of vedolizumab with advancing age in patients with ulcerative colitis: Results from the GEMINI 1 study

V. Yajnik*1, N. Khan2, M. Dubinsky3, J. Axler4, A. Green5, B. Abhyankar6, K. Lasch7

1Massachusetts General Hospital, Harvard Medical School, Gastroenterology, Boston, MA, United States, 2University of Pennsylvania, Perelman School of Medicine, Medicine, Philadelphia, Pennsylvania, United States, 3Mount Sinai Hospital, Pediatric Gastroenterology, New York, United States, 4Toronto Digestive Disease Associates, University of Toronto, Gastroenterology, Toronto, Canada, 5Takeda Global Research & Development Centre (Europe) Ltd., Statistics, London, United Kingdom, 6Takeda Global Research and Development Centre (Europe) Ltd., Clinical Science, London, United Kingdom, 7Takeda Pharmaceuticals International Inc., Medical Affairs, Deerfield, IL, United States

Background

The efficacy and safety of vedolizumab (VDZ), a gut-selective monoclonal antibody to α4β7 integrin for the treatment of patients (pts) with ulcerative colitis (UC), have been demonstrated. Here we report post hoc analyses of data from the placebo (PBO)-controlled GEMINI 1 study (NCT00783718)[1] that evaluated the effects of VDZ with advancing age in pts with UC.

Methods

In GEMINI 1, pts received double-blind (DB) VDZ or PBO (induction intent-to-treat [ITT] population) or open-label VDZ at weeks (wks) 0 and 2. At wk 6 (end of induction), VDZ responders were re-randomised to receive DB VDZ every 8 or 4 wks (Q8W or Q4W) or PBO up to wk 52 (maintenance ITT population). Efficacy endpoints and adverse events (AEs) were analysed by baseline (wk 0) age category (<35, 35 to 55, and >55 years [yrs]).

Results

At baseline, 139 (37%), 185 (49%), and 50 (13%) pts in the induction ITT population and 155 (42%), 161 (43%), and 57 (15%) pts in the maintenance ITT population were aged <35, 35 to 55, and >55 yrs, respectively. The primary clinical efficacy endpoint for induction treatment in GEMINI 1 was clinical response (≥3-point reduction in complete Mayo score, ≥30% change from baseline and ≥1-point decrease in rectal bleeding subscore [RBS] or absolute RBS of ≤1) at wk 6 and was achieved by 44 (51%), 50 (47%), and 12 (38%) VDZ-treated pts aged <35, 35 to 55, and >55 yrs, respectively. At wk 52, 34 (34%) pts aged <35, 58 (53%) aged 35 to 55, and 15 (42%) aged >55 yrs achieved clinical remission (complete Mayo score of ≤2 points and no individual subscore >1 point). Rates of AEs were similar between VDZ and PBO and were also similar across the ages (Table). Three malignancies were reported (aged 32 ITT VDZ Q8W: colon cancer; aged 40 ITT PBO: transitional cell carcinoma; aged 73 ITT PBO: colon cancer). One death occurred during the study: acute cardiac death of a 66-yr-old man with a history of ischemic heart disease who had received 1 dose of VDZ.

Conclusion

These data suggest that the safety and efficacy of VDZ in pts with UC were generally similar across the age categories analysed. Data interpretation is limited by the small pt population aged >55 yrs. These findings should be further evaluated in prospective studies.

 

Table:Adverse events in patients with UC by baseline age category (GEMINI 1)

ECCOJC jju027 P566 F0001

 

The clinical study was funded by Millennium Pharmaceuticals, Inc. (d/b/a Takeda Pharmaceuticals International Co.). Medical writing assistance was provided by inVentiv Medical Communications and supported by Takeda Pharmaceuticals International, Inc

References:

[1] Feagan BG, (2013), Vedolizumab as induction and maintenance therapy for ulcerative colitis, N Engl J Med, 699-710