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P330 Efficacy and safety of vedolizumab with advancing age in patients with Crohn's disease: Results from the GEMINI 2 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

Vedolizumab (VDZ) is a gut-selective monoclonal antibody to α4β7 integrin for the treatment of patients (pts) with Crohn's disease (CD). The efficacy and safety of VDZ have been demonstrated in the phase 3 placebo (PBO)-controlled GEMINI 2 study (NCT00783692).[1] Here we report post hoc analyses of data from GEMINI 2 that evaluate the effects of VDZ with advancing age in pts with CD.

Methods

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

Results

At baseline, 178 (48%), 161 (44%), and 29 (8%) pts in the induction and 246 (53%), 179 (39%), and 36 (8%) pts in the maintenance ITT populations were aged <35, 35 to 55, and >55 years, respectively. At week 6, there were 31 (28%) VDZ-treated pts aged <35, 32 (33%) aged 35 to 55, and 6 (50%) aged >55 years with response (≥100-point reduction in CD Activity Index [CDAI] score from baseline). Remission (CDAI total score ≤150) was achieved by 16 (14%), 15 (16%), and 1 (8%) VDZ-treated pts in each age category, respectively. At week 52, remission was achieved by 65 (38%), 42 (37%), and 9 (41%) pts treated with VDZ aged <35, 35 to 55, and >55 years, respectively. AEs occurred at similar rates across the ages (Table). Three malignancies were reported in VDZ-treated pts aged 20 years (carcinoid tumour of the appendix), 45 years (breast cancer), and 52 years (squamous cell carcinoma [skin]). Five deaths were reported: 3 VDZ-treated pts aged <35 years (myocarditis; CD and sepsis; septic shock), 1 VDZ-treated pt aged 46 years (intentional overdose), and 1 PBO-treated pt aged 75 years (bronchopneumonia).

Conclusion

These data suggest that the safety and efficacy of VDZ were generally similar in CD pts across all ages. Interpretation of data is limited by the small pt population aged >55 years; these findings should be further evaluated in prospective studies.

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:

 

ECCOJC jju027 P330 F0001

 

[1] Sandborn WJ, (2013), Vedolizumab as induction and maintenance therapy for Crohn's disease, N Engl J Med, 711-721