The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium.
We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD).



Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.



We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).



VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Parambir S
PS
Dulai
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.|Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
Siddharth
S
Singh
Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
Xiaoqian
X
Jiang
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Farhad
F
Peerani
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Neeraj
N
Narula
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
Khadija
K
Chaudrey
Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Diana
D
Whitehead
Division of Gastroenterology, New York University (NYU), New York, New York, USA.
David
D
Hudesman
Division of Gastroenterology, Montefiore Medical Center, New York, New York, USA.
Dana
D
Lukin
Division of Gastroenterology, NSLIJ Lenox Hill, New York, New York, USA.
Arun
A
Swaminath
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Eugenia
E
Shmidt
Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
Shuang
S
Wang
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Brigid S
BS
Boland
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
John T
JT
Chang
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
Sunanda
S
Kane
Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Corey A
CA
Siegel
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA.
Edward V
EV
Loftus
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
William J
WJ
Sandborn
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Bruce E
BE
Sands
Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Jean-Frederic
JF
Colombel
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001004:Anus Diseases / Q000209:etiology; D015331:Cohort Studies; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009902:Optic Neuritis / Q000139:chemically induced; D016016:Proportional Hazards Models; D012074:Remission Induction; D012189:Retrospective Studies; D012720:Severity of Illness Index; D012907:Smoking / Q000453:epidemiology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors; D055815:Young Adult
D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; C543529:vedolizumab