Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10359034" target="_blank" >RIV/00216208:11110/17:10359034 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1097/MIB.0000000000000979" target="_blank" >http://dx.doi.org/10.1097/MIB.0000000000000979</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1097/MIB.0000000000000979" target="_blank" >10.1097/MIB.0000000000000979</a>
Alternative languages
Result language
angličtina
Original language name
Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy
Original language description
Background: Vedolizumab is a gut-selective alpha(4)beta(7) integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naive to tumor necrosis factor-alpha (TNF-alpha) antagonist therapy (TNF-naive) or who had discontinued TNF-a antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population). Methods: Post hoc analyses of the efficacy data for 516 TNF-naive and 960 TNF-failure patients from the GEMINI 2 and GEMINI 3 trials were evaluated at weeks 6, 10, and 52 and included clinical remission (CD Activity Index [CDAI] score <= 150), enhanced clinical response(>= 100-point decrease from baseline in CDAI score), durable clinical remission (remission at >= 80% of visits), and corticosteroid-free remission. Adverse events were summarized for the TNF-naive and TNF-failure subgroups by treatment received. Results: Among patients who responded to vedolizumab induction at week 6, 48.9% of TNF-naive and 27.7% of TNF-failure patients were in remission with vedolizumab at week 52 (versus 26.8% and 12.8% with placebo). Clinical efficacy was similar between the different types of TNF-alpha antagonist failure or the number of prior TNF-alpha antagonists failed. Safety profiles were similar in both subpopulations. Conclusions: Vedolizumab had increased efficacy over placebo in CD patients irrespective of TNF-a antagonist treatment history. Overall, rates of response and remission were numerically higher in patients receiving vedolizumab as a first biologic than in patients who had experienced TNF failure.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30219 - Gastroenterology and hepatology
Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Inflammatory Bowel Diseases
ISSN
1078-0998
e-ISSN
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Volume of the periodical
23
Issue of the periodical within the volume
1
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
97-106
UT code for WoS article
000393897100018
EID of the result in the Scopus database
2-s2.0-85002497981