Comparative Safety and Effectiveness of Vedolizumab to Tumor Necrosis Factor Antagonist Therapy for Ulcerative Colitis

被引：39

作者：

Lukin, Dana ^{[1
]}

Faleck, David ^{[2
]}

Xu, Ronghui ^{[3
]}

Zhang, Yiran ^{[3
]}

Weiss, Aaron ^{[1
]}

Aniwan, Satimai ^{[4
]}

Kadire, Siri ^{[5
]}

Tran, Gloria ^{[5
]}

Rahal, Mahmoud ^{[5
]}

Winters, Adam ^{[2
]}

Chablaney, Shreya ^{[2
]}

Koliani-Pace, Jenna L.

Meserve, Joseph ^{[3
]}

Campbell, James P. ^{[7
]}

Kochhar, Gursimran ^{[6
]}

Bohm, Matthew ^{[5
]}

Varma, Sashidhar ^{[5
]}

Fischer, Monika ^{[5
]}

Boland, Brigid ^{[3
]}

Singh, Siddharth ^{[3
]}

Hirten, Robert ^{[2
]}

Ungaro, Ryan ^{[2
]}

Lasch, Karen ^{[9
]}

Shmidt, Eugenia ^{[7
]}

Jairath, Vipul ^{[10
]}

Hudesman, David ^{[11
]}

Chang, Shannon ^{[11
]}

Swaminath, Arun ^{[12
]}

Shen, Bo ^{[6
,8
]}

Kane, Sunanda ^{[4
]}

Loftus, Edward, V ^{[4
]}

Sands, Bruce E. ^{[2
]}

Colombel, Jean-Frederic ^{[2
]}

Siegel, Corey A.

Sandborn, William J. ^{[3
]}

Dulai, Parambir S. ^{[3
]}

机构：

[1] Montefiore Med Ctr, New York, NY USA

[2] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[3] Univ Calif San Diego, La Jolla, CA 92093 USA

[4] Mayo Clin, Rochester, MN USA

[5] Indiana Univ, Indianapolis, IN 46204 USA

[6] Dartmouth Hitchcock Med Ctr, Lebanon, NH 03766 USA

[7] Univ Minnesota, Minneapolis, MN USA

[8] Cleveland Clin Fdn, 9500 Euclid Ave, Cleveland, OH 44195 USA

[9] Takeda Pharmaceut, Lexington, MA USA

[10] Univ Western Ontario, London, ON, Canada

[11] NYU, New York, NY USA

[12] Lenox Hill Hosp, New York, NY 10021 USA

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2022年 / 20卷 / 01期

关键词：

Health Outcomes; Comparative Research; Biologics; INFLAMMATORY-BOWEL-DISEASE; PROPENSITY SCORE METHODS; VARIABLE SELECTION; OUTCOMES; GUIDELINES; MANAGEMENT; INFECTION; SURVIVAL;

D O I：

10.1016/j.cgh.2020.10.003

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BACKGROUND & AIMS: We aimed to compare safety and effectiveness of vedolizumab to tumor necrosis factor (TNF)-antagonist therapy in ulcerative colitis in routine practice. METHODS: A multicenter, retrospective, observational cohort study (May 2014 to December 2017) of ulcerative colitis patients treated with vedolizumab or TNF-antagonist therapy. Propensity score weighted comparisons for development of serious adverse events and achievement of clinical remission, steroid-free clinical remission, and steroid-free deep remission. A priori determined subgroup comparisons in TNF-antagonist-naive and -exposed patients, and for vedolizumab against infliximab and subcutaneous TNF-antagonists separately. RESULTS: A total of 722 (454 vedolizumab, 268 TNF antagonist) patients were included. Vedolizumabtreated patients were more likely to achieve clinical remission (hazard ratio [HR], 1.651; 95% confidence interval [CI], 1.229-2.217), steroid-free clinical remission (HR, 1.828; 95% CI, 1.135-2.944), and steroid-free deep remission (HR, 2.819; 95% CI, 1.496-5.310) than those treated with TNF antagonists. Results were consistent across subgroup analyses in TNF-antagonist-naive and - exposed patients, and for vedolizumab vs infliximab and vs subcutaneous TNF-antagonist agents separately. Overall, there were no statistically significant differences in the risk of serious adverse events (HR, 0.899; 95% CI, 0.502-1.612) or serious infections (HR, 1.235; 95% CI, 0.608-2.511) between vedolizumab-treated and TNF-antagonist-treated patients. However, in TNF-antagonist - naive patients, vedolizumab was less likely to be associated with serious adverse events than TNF antagonists (HR, 0.192; 95% CI, 0.049-0.754). CONCLUSIONS: Treatment of ulcerative colitis with vedolizumab is associated with higher rates of remission than treatment with TNF-antagonist therapy in routine practice, and lower rates of serious adverse events in TNF-antagonist-naive patients.

引用

页码：126 / 135

页数：10

共 43 条

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