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Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study

Background: Infusion reactions (IRs) are the most common adverse events (AEs) of infliximab (IFX) treatment in patients with inflammatory bowel disease (IBD). Prophylactic premedication (PM) with corticosteroids or antihistamines prior to IFX infusions has been used in clinical practice, but its eff...

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Autores principales: Szymanska, Edyta, Dadalski, Maciej, Sieczkowska-Golub, Joanna, Jarzebicka, Dorota, Meglicka, Monika, Osiecki, Marcin, Wiernicka, Anna, Lebensztejn, Dariusz M., Korczowski, Bartosz, Kierkus, Jaroslaw
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8303466/
https://www.ncbi.nlm.nih.gov/pubmed/34300342
http://dx.doi.org/10.3390/jcm10143177
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author Szymanska, Edyta
Dadalski, Maciej
Sieczkowska-Golub, Joanna
Jarzebicka, Dorota
Meglicka, Monika
Osiecki, Marcin
Wiernicka, Anna
Lebensztejn, Dariusz M.
Korczowski, Bartosz
Kierkus, Jaroslaw
author_facet Szymanska, Edyta
Dadalski, Maciej
Sieczkowska-Golub, Joanna
Jarzebicka, Dorota
Meglicka, Monika
Osiecki, Marcin
Wiernicka, Anna
Lebensztejn, Dariusz M.
Korczowski, Bartosz
Kierkus, Jaroslaw
author_sort Szymanska, Edyta
collection PubMed
description Background: Infusion reactions (IRs) are the most common adverse events (AEs) of infliximab (IFX) treatment in patients with inflammatory bowel disease (IBD). Prophylactic premedication (PM) with corticosteroids or antihistamines prior to IFX infusions has been used in clinical practice, but its efficacy is not known. The aim of this study was to assess the influence of steroid PM on IR incidence in pediatric patients with IBD receiving IFX. Methods: We performed a case–control study that included pediatric patients with IBD receiving IFX. Patients were divided into four subgroups according to the agent and PM they received: Remicade (original drug) + PM, and two biosimilars—Reshma +/− PM, and Flixabi—PM. At our site, until 2018, PM with steroids was used as a part of standard IFX infusion (PM+); however, since then, this method has no longer been administered (PM−). IRs were divided into mild/severe reactions. Differences between subgroups were assessed with the appropriate chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for co-medication usage. Results: There were 105 children (55 PM+, 44 male, mean age 15 years) included in the study who received 1276 infusions. There was no difference between the PM+ and PM− subgroups, either in incidence of IR (18.2% vs. 16.0% of patients, p > 0.05) or in percentage of infusions followed by IR (2.02% vs. 1.02% of infusions, p > 0.5). The OR of developing IR when using PM was 0.34, and the difference in IRs ratio in PM+ and PM− patients was not statistically significant (95% CI, 0.034–1.9). There were 11/18 (61.1%) severe IRs (anaphylactic shock) reported in all patients (both PM+ and PM−). Conclusion: At our site, the incidence of IR was low, and PM did not decrease the incidence of IR in pediatric patients with IBD receiving IFX. These results indicate that PM with steroids should not be a standard part of IFX infusion to prevent IR.
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spelling pubmed-83034662021-07-25 Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study Szymanska, Edyta Dadalski, Maciej Sieczkowska-Golub, Joanna Jarzebicka, Dorota Meglicka, Monika Osiecki, Marcin Wiernicka, Anna Lebensztejn, Dariusz M. Korczowski, Bartosz Kierkus, Jaroslaw J Clin Med Article Background: Infusion reactions (IRs) are the most common adverse events (AEs) of infliximab (IFX) treatment in patients with inflammatory bowel disease (IBD). Prophylactic premedication (PM) with corticosteroids or antihistamines prior to IFX infusions has been used in clinical practice, but its efficacy is not known. The aim of this study was to assess the influence of steroid PM on IR incidence in pediatric patients with IBD receiving IFX. Methods: We performed a case–control study that included pediatric patients with IBD receiving IFX. Patients were divided into four subgroups according to the agent and PM they received: Remicade (original drug) + PM, and two biosimilars—Reshma +/− PM, and Flixabi—PM. At our site, until 2018, PM with steroids was used as a part of standard IFX infusion (PM+); however, since then, this method has no longer been administered (PM−). IRs were divided into mild/severe reactions. Differences between subgroups were assessed with the appropriate chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for co-medication usage. Results: There were 105 children (55 PM+, 44 male, mean age 15 years) included in the study who received 1276 infusions. There was no difference between the PM+ and PM− subgroups, either in incidence of IR (18.2% vs. 16.0% of patients, p > 0.05) or in percentage of infusions followed by IR (2.02% vs. 1.02% of infusions, p > 0.5). The OR of developing IR when using PM was 0.34, and the difference in IRs ratio in PM+ and PM− patients was not statistically significant (95% CI, 0.034–1.9). There were 11/18 (61.1%) severe IRs (anaphylactic shock) reported in all patients (both PM+ and PM−). Conclusion: At our site, the incidence of IR was low, and PM did not decrease the incidence of IR in pediatric patients with IBD receiving IFX. These results indicate that PM with steroids should not be a standard part of IFX infusion to prevent IR. MDPI 2021-07-19 /pmc/articles/PMC8303466/ /pubmed/34300342 http://dx.doi.org/10.3390/jcm10143177 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Szymanska, Edyta
Dadalski, Maciej
Sieczkowska-Golub, Joanna
Jarzebicka, Dorota
Meglicka, Monika
Osiecki, Marcin
Wiernicka, Anna
Lebensztejn, Dariusz M.
Korczowski, Bartosz
Kierkus, Jaroslaw
Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title_full Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title_fullStr Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title_full_unstemmed Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title_short Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease—A Single Center Case–Control Study
title_sort premedication does not influence the incidence of infliximab infusion reactions in pediatric patients with inflammatory bowel disease—a single center case–control study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8303466/
https://www.ncbi.nlm.nih.gov/pubmed/34300342
http://dx.doi.org/10.3390/jcm10143177
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