Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10364183" target="_blank" >RIV/00216208:11110/17:10364183 - isvavai.cz</a>

Alternative codes found

RIV/00064203:_____/17:10364183 RIV/00064165:_____/17:10364183

Result on the web

<a href="http://dx.doi.org/10.1080/14740338.2017.1323330" target="_blank" >http://dx.doi.org/10.1080/14740338.2017.1323330</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/14740338.2017.1323330" target="_blank" >10.1080/14740338.2017.1323330</a>

Result language

angličtina

Original language name

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

Original language description

Background: Safety data of the real life&apos; use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. Methods: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. Results: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p&lt;0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%, p&lt;0.001, OR 19(5-73)) during the induction therapy were predictive factors for infusion reactions. Conclusions: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30104 - Pharmacology and pharmacy

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2017

Confidentiality

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

Name of the periodical

Expert Opinion on Drug Safety

ISSN

1474-0338

e-ISSN

—

Volume of the periodical

16

Issue of the periodical within the volume

8

Country of publishing house

GB - UNITED KINGDOM

Number of pages

6

Pages from-to

885-890

UT code for WoS article

000406282700003

EID of the result in the Scopus database

2-s2.0-85019756405