The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium

被引:251
作者
Dulai, Parambir S. [1 ]
Singh, Siddharth [1 ,2 ]
Jiang, Xiaoqian [2 ]
Peerani, Farhad [3 ]
Narula, Neeraj [3 ]
Chaudrey, Khadija [4 ]
Whitehead, Diana [5 ]
Hudesman, David [6 ]
Lukin, Dana [7 ]
Swaminath, Arun [8 ]
Shmidt, Eugenia [3 ]
Wang, Shuang [2 ]
Boland, Brigid S. [1 ]
Chang, John T. [1 ]
Kane, Sunanda [4 ]
Siegel, Corey A. [5 ]
Loftus, Edward V. [4 ]
Sandborn, William J. [1 ]
Sands, Bruce E. [3 ]
Colombel, Jean-Frederic [3 ]
机构
[1] Univ Calif San Diego, Div Gastroenterol, 9500 Gilman Dr, La Jolla, CA 92093 USA
[2] Univ Calif San Diego, Dept Biomed Informat, La Jolla, CA 92093 USA
[3] Icahn Sch Med Mt Sinai, Div Gastroenterol, New York, NY 10029 USA
[4] Mayo Clin, Div Gastroenterol & Hepatol, Minneapolis, MN USA
[5] Dartmouth Hitchcock Med Ctr, Div Gastroenterol & Hepatol, Lebanon, NH 03766 USA
[6] NYU, Div Gastroenterol, New York, NY USA
[7] Montefiore Med Ctr, Div Gastroenterol, New York, NY USA
[8] NSLIJ Lenox Hill, Div Gastroenterol, New York, NY USA
关键词
INFLAMMATORY-BOWEL-DISEASE; ANTI-TNF THERAPY; INDUCTION THERAPY; COMBINATION THERAPY; ENDOTHELIAL-CELLS; EFFICACY; METAANALYSIS; BIOLOGICS; REMISSION; SMOKING;
D O I
10.1038/ajg.2016.236
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
OBJECTIVES: We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
引用
收藏
页码:1147 / 1155
页数:9
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