We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment.
Retrospective review (May 2014-December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy.
We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n= 64/321) for clinical remission, 17% (n=35/203) for endoscopic remission, 15% (n=30/195) for corticosteroid-free remission, and 14% (n= 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n= 70) or a significant clinical response (n=36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n=56), need for surgery (n=29), or adverse event (n=6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%).
In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.
1Icahn School of Medicine at Mount Sinai, New York, NY, uSA. 2McMaster university Medical Centre, Hamilton, ON, Canada. 3university of Alberta, Edmonton, AB, Canada. 4University of California - San Diego, La Jolla, CA, uSA. 5Cleveland Clinic Foundation, Cleveland, OH, uSA. 6Mayo Clinic, Rochester, MN, uSA. 7indiana university, indianapolis, iN, uSA. 8Dartmouth-Hitchcock Medical Center, Lebanon, NH, uSA. 9North Shore university Hospital, Manhasset, NY, uSA. 10New York university, New York, NY, uSA. 11Takeda Pharmaceuticals uSA inc., Deerfield, iL, uSA. 12Montefiore Medical Center, New York, NY, uSA. 13Lenox Hill Hospital, New York, NY, uSA. 14University of Mississippi, Jackson, MS, uSA. These authors contributed equally: Neeraj Narula, Farhad Peerani.
Correspondence: P.S.D. (email: email@example.com)
Received 29 August 2017; accepted 22 May 2018; Published online 27 June 2018