دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium.
المؤلفون: Dulai PS; Division of Gastroenterology, University of California San Diego, La Jolla, California, USA., Singh S; 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., Jiang X; Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA., Peerani F; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Narula N; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Chaudrey K; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA., Whitehead D; Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA., Hudesman D; Division of Gastroenterology, New York University (NYU), New York, New York, USA., Lukin D; Division of Gastroenterology, Montefiore Medical Center, New York, New York, USA., Swaminath A; Division of Gastroenterology, NSLIJ Lenox Hill, New York, New York, USA., Shmidt E; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Wang S; Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA., Boland BS; Division of Gastroenterology, University of California San Diego, La Jolla, California, USA., Chang JT; Division of Gastroenterology, University of California San Diego, La Jolla, California, USA., Kane S; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA., Siegel CA; Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA., Loftus EV; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA., Sandborn WJ; Division of Gastroenterology, University of California San Diego, La Jolla, California, USA., Sands BE; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA., Colombel JF; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
المصدر: The American journal of gastroenterology [Am J Gastroenterol] 2016 Aug; Vol. 111 (8), pp. 1147-55. Date of Electronic Publication: 2016 Jun 14.
نوع المنشور: Journal Article; Observational Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Wolters Kluwer Health Country of Publication: United States NLM ID: 0421030 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1572-0241 (Electronic) Linking ISSN: 00029270 NLM ISO Abbreviation: Am J Gastroenterol Subsets: MEDLINE
أسماء مطبوعة: Publication: <2019-> : [Philadelphia, PA] : Wolters Kluwer Health
Original Publication: New York, Elsevier Science, -2003.
مواضيع طبية MeSH: Antibodies, Monoclonal, Humanized/*therapeutic use , Crohn Disease/*drug therapy , Gastrointestinal Agents/*therapeutic use, Adult ; Anus Diseases/etiology ; Cohort Studies ; Crohn Disease/complications ; Female ; Humans ; Male ; Middle Aged ; Optic Neuritis/chemically induced ; Proportional Hazards Models ; Remission Induction ; Retrospective Studies ; Severity of Illness Index ; Smoking/epidemiology ; Treatment Outcome ; Tumor Necrosis Factor-alpha/antagonists & inhibitors ; Young Adult
مستخلص: 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.
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معلومات مُعتمدة: R21 LM012060 United States LM NLM NIH HHS; Canada CIHR; T32 DK007202 United States DK NIDDK NIH HHS; R00 LM011392 United States LM NLM NIH HHS; R00 HG008175 United States HG NHGRI NIH HHS; T15 LM011271 United States LM NLM NIH HHS; U54 HL108460 United States HL NHLBI NIH HHS
المشرفين على المادة: 0 (Antibodies, Monoclonal, Humanized)
0 (Gastrointestinal Agents)
0 (Tumor Necrosis Factor-alpha)
9RV78Q2002 (vedolizumab)
تواريخ الأحداث: Date Created: 20160615 Date Completed: 20170620 Latest Revision: 20220716
رمز التحديث: 20231215
DOI: 10.1038/ajg.2016.236
PMID: 27296941
قاعدة البيانات: MEDLINE
الوصف
تدمد:1572-0241
DOI:10.1038/ajg.2016.236