Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy

Popis výsledku v původním jazyce

Background: Vedolizumab is a gut-selective alpha(4)beta(7) integrin antagonist for the treatment of moderately to severely active Crohn&apos;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 &lt;= 150), enhanced clinical response(&gt;= 100-point decrease from baseline in CDAI score), durable clinical remission (remission at &gt;= 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.

Název v anglickém jazyce

Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy

Popis výsledku anglicky

Background: Vedolizumab is a gut-selective alpha(4)beta(7) integrin antagonist for the treatment of moderately to severely active Crohn&apos;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 &lt;= 150), enhanced clinical response(&gt;= 100-point decrease from baseline in CDAI score), durable clinical remission (remission at &gt;= 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Inflammatory Bowel Diseases

ISSN

1078-0998

e-ISSN

—

Svazek periodika

23

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

97-106

Kód UT WoS článku

000393897100018

EID výsledku v databázi Scopus

2-s2.0-85002497981