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Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort
A. Bálint, M. Rutka, Z. Végh, Z. Kürti, KB. Gecse, J. Banai, L. Bene, B. Gasztonyi, T. Kristóf, L. Lakatos, P. Miheller, K. Palatka, Á. Patai, Á. Salamon, T. Szamosi, Z. Szepes, GT. Tóth, Á. Vincze, R. Bor, Á. Milassin, A. Fábián, F. Nagy, M....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie
- MeSH
- adalimumab aplikace a dávkování MeSH
- biosimilární léčivé přípravky aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- ELISA MeSH
- gastrointestinální látky aplikace a dávkování škodlivé účinky MeSH
- idiopatické střevní záněty farmakoterapie MeSH
- intravenózní infuze MeSH
- kohortové studie MeSH
- lidé MeSH
- mladý dospělý MeSH
- monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- protilátky imunologie MeSH
- TNF-alfa antagonisté a inhibitory MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- Geografické názvy
- Česká republika MeSH
- Maďarsko MeSH
BACKGROUND: Safety data of the 'real life' 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 < 0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%, p < 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.
1st Department of Medicine Peterfy Hospital Budapest Hungary
1st Department of Medicine University of Szeged Szeged Hungary
b 1st Department of Internal Medicine Semmelweis University Budapest Hungary
c Military Hospital State Health Centre Budapest Hungary
e 2nd Department of Medicine Zala County Hospital Zalaegerszeg Hungary
f 2nd Department of Medicine B A Z County and University Teaching Hospital Miskolc Hungary
g Department of Internal Medicine Csolnoky Ferenc Regional Hospital Veszprém Hungary
h 2nd Department of Internal Medicine Semmelweis University Budapest Hungary
IBD Clinical and Research Centre Iscarea s Prague Czech Republic
j Department of Medicine and Gastroenterology Markusovszky Hospital Szombathely Hungary
k Department of Gastroenterology Tolna County Teaching Hospital Szekszárd Hungary
l Department of Gastroenterology Janos Hospital Budapest Hungary
m 1st Department of Medicine University of Pécs Pécs Hungary
Citace poskytuje Crossref.org
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- $a Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort / $c A. Bálint, M. Rutka, Z. Végh, Z. Kürti, KB. Gecse, J. Banai, L. Bene, B. Gasztonyi, T. Kristóf, L. Lakatos, P. Miheller, K. Palatka, Á. Patai, Á. Salamon, T. Szamosi, Z. Szepes, GT. Tóth, Á. Vincze, R. Bor, Á. Milassin, A. Fábián, F. Nagy, M. Kolar, M. Bortlik, D. Duricova, V. Hruba, M. Lukas, K. Mitrova, K. Malickova, M. Lukas, PL. Lakatos, T. Molnár, K. Farkas,
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- $a BACKGROUND: Safety data of the 'real life' 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 < 0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%, p < 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.
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