AGA Abstracts 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. Sa1272 Efficacy and Safety of Retreatment With Vedolizumab in Patients With Ulcerative Colitis Bruce E. Sands, Ira Shafran, Francis A. Farraye, Adam S. Cheifetz, Brihad Abhyankar, Serap Sankoh, Michael D. Smyth Background In symptomatic patients with ulcerative colitis (UC), retreatment with a biologic agent after a drug holiday is often necessary given the recurrent nature of the disease. Vedolizumab (VDZ) is a monoclonal antibody to alpha4beta7 integrin with proven efficacy and safety in the treatment of UC (GEMINI 1; NCT00783718). 1 This interim analysis (May 22, 2009 - June 27, 2013) of data from the ongoing, open-label, GEMINI long-term safety (LTS) study (NCT00790933) evaluated the effects of VDZ retreatment in UC patients who rolled over from the double-blind, placebo (PBO)-controlled GEMINI 1 study. Methods In GEMINI 1, after 6 weeks of induction therapy, patients who responded to VDZ were re- randomized to PBO or VDZ every 8 weeks (Q8W) or every 4 weeks (Q4W) during the 46- week maintenance period (maintenance intent-to-treat [ITT] population). Patients from GEMINI 1 who completed the study (n=199) or withdrew early (due to sustained non- response, disease worsening, or the need for rescue medication; n=131) were eligible to enroll into GEMINI LTS to receive open-label VDZ Q4W. Here we evaluate rates of clinical response and remission with VDZ retreatment in these rollover patients in GEMINI LTS (prespecified analyses). Rates were calculated based on the number of patients at week 0 of the GEMINI LTS study. Adverse event (AE) and serious adverse event (SAE) rates were also evaluated. Results In GEMINI LTS, patients retreated with VDZ after up to 1 year of drug holiday following re-randomization to PBO (weeks 6 to 52; PBO completers) or due to loss of response or sustained non-response (VDZ Q8W and Q4W early terminators) regained response (Table). Similar trends were observed with VDZ retreatment in the subpop- ulations of completers or early terminators with a history of tumor necrosis factor antagonist therapy failure. No increase in rates of AEs or SAEs was observed with VDZ retreatment in completers/early terminators. Conclusion Patients with UC from GEMINI 1 who responded to VDZ induction therapy and then had a drug holiday for up to 1 year were safely retreated with VDZ Q4W in GEMINI LTS and experienced treatment benefits. 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. Reference 1. Feagan BG, et al. N Engl J Med. 2013;369:699-710. Sa1273 Efficacy and Safety of Retreatment With Vedolizumab in Patients With Crohn's Disease Bruce E. Sands, Ira Shafran, Francis A. Farraye, Adam S. Cheifetz, Brihad Abhyankar, Serap Sankoh, Michael D. Smyth Background Retreatment of patients with Crohn's disease (CD) after a drug holiday is a commonly encountered clinical situation. Vedolizumab (VDZ) is a monoclonal antibody to alpha4beta7 integrin. The efficacy and safety of VDZ in patients with CD were demonstrated S-278 AGA Abstracts in the double-blind, placebo (PBO)-controlled, phase 3 GEMINI 2 study (NCT00783692). 1 This interim analysis (May 22, 2009 - June 27, 2013) of data from the ongoing, open- label GEMINI long-term safety (LTS) study (NCT00790933) examined the effects of VDZ retreatment in patients with CD who rolled over from the GEMINI 2 study after a drug holiday of up to 1 year. Methods At week 6 of the GEMINI 2 study, patients with response to VDZ induction therapy were re-randomized to receive PBO or VDZ every 8 or 4 weeks (Q8W or Q4W) during the 46-week maintenance phase (maintenance intent-to-treat [ITT] population). Patients from GEMINI 2 who completed the study (n=205) or withdrew early (due to sustained non-response, disease worsening, or the need for rescue medication; n= 156) were eligible to enroll into GEMINI LTS to receive open-label VDZ Q4W. Here we evaluate rates of clinical response and remission with VDZ retreatment in these rollover patients in GEMINI LTS (prespecified analyses). Rates were calculated based on the number of patients at week 0 of GEMINI LTS. Rates of adverse event (AE) and serious adverse event (SAE) were also evaluated. Results In GEMINI LTS, patients from GEMINI 2 who were re- randomized to PBO in the maintenance phase (weeks 6 to 52; PBO completers) or those who discontinued due to loss of response or sustained non-response (VDZ Q8W or Q4W early terminators [ETs]) regained response (Table). Similar trends were noted with VDZ retreatment in the subpopulations of completers or ETs with prior failure to tumor necrosis factor antagonist therapy. No increase in AE or SAE rates was observed with VDZ retreatment in GEMINI LTS. Rates of SAEs of anal fistula or abscess were <1% and 2%, respectively, in patients retreated with VDZ after a drug holiday (PBO completers + ETs combined) versus <1% and 1%, respectively, in patients who received VDZ treatment in both studies (VDZ Q8W and Q4W completers and ET combined). Conclusion Patients with CD from GEMINI 2 who responded to induction therapy with VDZ and had a drug holiday for up to 1 year were safely retreated with VDZ Q4W in GEMINI LTS and experienced clinical benefits. 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. Reference 1. Sandborn WJ, et al. N Engl J Med . 2013;369:711-721. Sa1274 Efficacy and Safety of Vedolizumab With Advancing Age in Patients With Ulcerative Colitis: Results From the GEMINI 1 Study Vijay Yajnik, Nabeel Khan, Marla Dubinsky, Jeffrey L. Axler, Alexandra Green, Brihad Abhyankar, Karen Lasch Background The efficacy and safety of vedolizumab (VDZ), a gut-selective monoclonal antibody to alpha4beta7 integrin for the treatment of patients with ulcerative colitis (UC), have been demonstrated in the phase 3 placebo (PBO)-controlled GEMINI 1 study. 1 Here we report post hoc analyses of data from GEMINI 1 that evaluate the effects of VDZ with advancing age in patients with UC. Methods In GEMINI 1, patients received double-blind (DB) VDZ or PBO (induction intent-to-treat [ITT] population) or open-label VDZ at weeks 0 and 2. At week 6 (end of induction), VDZ responders were re-randomized 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 analyzed by baseline (week 0) age category (<35, 35 to 55, and >55 years). Results At baseline, 139 (37%), 185 (49%), and 50 (13%) patients in the induction ITT population and 155 (42%), 161 (43%), and 57 (15%) patients in the maintenance ITT population were aged <35, 35 to 55, and >55 years, respectively. At week 6, 44 (51%), 50 (47%), and 12 (38%) VDZ-treated patients aged <35, 35 to 55, and >55 years, respectively, had a 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 week 52, 34 (34%) patients aged <35, 58 (53%) aged 35 to 55, and 15 (42%) aged >55 years 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-year- 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 patients with UC were generally similar across the age categories analyzed. Data interpretation is limited by the small patient