Vedolizumab vs. Ustekinumab as second-line therapy in Crohn's disease in clinical practice

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F19%3A10394626" target="_blank" >RIV/00064165:_____/19:10394626 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/19:10394626 RIV/00064203:_____/19:10394626

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ubQwTcpBm6" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=ubQwTcpBm6</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.14735/AMGH201925" target="_blank" >10.14735/AMGH201925</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Vedolizumab vs. Ustekinumab as second-line therapy in Crohn's disease in clinical practice

Popis výsledku v původním jazyce

Background: Vedolizumab (VDZ) and ustekinumab (UST) have become available for the treatment of Crohn&apos;s disease (CD), however, due to limited clinical experience, the optimal treatment strategy after a failure of anti-tumor necrosis factor (anti-TNF) has yet to be elucidated. In our study, we aim to evaluate the efciency and safety of VDZ and UST as second-line classes of biological therapy in a head-to-head manner in comparable populations of CD patients. Methods: Consecutive patients with CD who have previously been treated with anti-TNF therapy were included. Patients were followed at regular intervals coincident with drug applications and clinical activity (HBI - Harvey-Bradshaw Index), inflammatory markers (C-reactive protein, fecal calprotectin) and adverse events were recorded. The primary outcome was the proportion of patients in clinical remission in weeks 30-32 (HBI &lt;= 4), the clinical response in terms of HBI decrease, and the withdrawal rate. Results: Forty-five patients with VDZ and 50 with UST were included. Both groups were comparable in all the evaluated parameters with the exception of the male-to-female ratio and the proportion of patients with penetrating disease phenotype. The proportion of patients in clinical remission increased from 44.4% at baseline to 58.1% in weeks 30-32 in the VDZ group and from 55.1% to 63.2% in the UST group; however, the increase was not statistically significant. The mean paired HBI diference between weeks 30-32 and baseline reached -1.94 +- 5.14 (p = 0.05) in the VDZ cohort and -2.94 +- 5.91 (p = 0.01) in the UST cohort. The proportion of patients in steroid-free clinical remission increased from 38.8% to 62.5% in the UST cohort (p = 0.04), and from 33.3% to 45.2% in the VDZ (p = 0.67). Six patients on VDZ and none on UST discontinued the treatment. Conclusion: Our study demonstrated a comparable efcacy of VDZ and UST with respect to the rate of clinical remission and biomarker response; however, the steroid-sparing efect of UST was more prominent. There is a need for prospective randomized head-to-head trials to assess the optimal position of new biological agents in the treatment of patients with CD.

Název v anglickém jazyce

Vedolizumab vs. Ustekinumab as second-line therapy in Crohn's disease in clinical practice

Popis výsledku anglicky

Background: Vedolizumab (VDZ) and ustekinumab (UST) have become available for the treatment of Crohn&apos;s disease (CD), however, due to limited clinical experience, the optimal treatment strategy after a failure of anti-tumor necrosis factor (anti-TNF) has yet to be elucidated. In our study, we aim to evaluate the efciency and safety of VDZ and UST as second-line classes of biological therapy in a head-to-head manner in comparable populations of CD patients. Methods: Consecutive patients with CD who have previously been treated with anti-TNF therapy were included. Patients were followed at regular intervals coincident with drug applications and clinical activity (HBI - Harvey-Bradshaw Index), inflammatory markers (C-reactive protein, fecal calprotectin) and adverse events were recorded. The primary outcome was the proportion of patients in clinical remission in weeks 30-32 (HBI &lt;= 4), the clinical response in terms of HBI decrease, and the withdrawal rate. Results: Forty-five patients with VDZ and 50 with UST were included. Both groups were comparable in all the evaluated parameters with the exception of the male-to-female ratio and the proportion of patients with penetrating disease phenotype. The proportion of patients in clinical remission increased from 44.4% at baseline to 58.1% in weeks 30-32 in the VDZ group and from 55.1% to 63.2% in the UST group; however, the increase was not statistically significant. The mean paired HBI diference between weeks 30-32 and baseline reached -1.94 +- 5.14 (p = 0.05) in the VDZ cohort and -2.94 +- 5.91 (p = 0.01) in the UST cohort. The proportion of patients in steroid-free clinical remission increased from 38.8% to 62.5% in the UST cohort (p = 0.04), and from 33.3% to 45.2% in the VDZ (p = 0.67). Six patients on VDZ and none on UST discontinued the treatment. Conclusion: Our study demonstrated a comparable efcacy of VDZ and UST with respect to the rate of clinical remission and biomarker response; however, the steroid-sparing efect of UST was more prominent. There is a need for prospective randomized head-to-head trials to assess the optimal position of new biological agents in the treatment of patients with CD.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

Gastroenterologie a hepatologie

ISSN

1804-7874

e-ISSN

—

Svazek periodika

73

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

7

Strana od-do

25-31

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85065516808