PMID- 34300342 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20210729 IS - 2077-0383 (Print) IS - 2077-0383 (Electronic) IS - 2077-0383 (Linking) VI - 10 IP - 14 DP - 2021 Jul 19 TI - Premedication Does Not Influence the Incidence of Infliximab Infusion Reactions in Pediatric Patients with Inflammatory Bowel Disease-A Single Center Case-Control Study. LID - 10.3390/jcm10143177 [doi] LID - 3177 AB - 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. FAU - Szymanska, Edyta AU - Szymanska E AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Dadalski, Maciej AU - Dadalski M AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Sieczkowska-Golub, Joanna AU - Sieczkowska-Golub J AUID- ORCID: 0000-0003-1381-0742 AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Jarzebicka, Dorota AU - Jarzebicka D AUID- ORCID: 0000-0002-3977-7541 AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Meglicka, Monika AU - Meglicka M AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Osiecki, Marcin AU - Osiecki M AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Wiernicka, Anna AU - Wiernicka A AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. FAU - Lebensztejn, Dariusz M AU - Lebensztejn DM AD - Department of Pediatrics, Gastroenterology, Hepatology, Nutrition and Allergology, Medical University of Bialystok, 15-089 Bialystok, Poland. FAU - Korczowski, Bartosz AU - Korczowski B AUID- ORCID: 0000-0003-1626-1283 AD - Department of Pediatrics and Pediatric Gastroenterology, College of Medical Sciences, University of Rzeszow, 35-310 Rzeszow, Poland. FAU - Kierkus, Jaroslaw AU - Kierkus J AUID- ORCID: 0000-0003-2272-1581 AD - Department of Gastroenterology, Hepatology, Feeding Disorders and Pediatrics, The Childrens' Memorial Health Institute, 04-730 Warsaw, Poland. LA - eng PT - Journal Article DEP - 20210719 PL - Switzerland TA - J Clin Med JT - Journal of clinical medicine JID - 101606588 PMC - PMC8303466 OTO - NOTNLM OT - inflammatory bowel disease OT - infliximab OT - infusion reaction OT - premedication COIS- The authors declare no conflict of interest. EDAT- 2021/07/25 06:00 MHDA- 2021/07/25 06:01 PMCR- 2021/07/19 CRDT- 2021/07/24 01:07 PHST- 2021/06/15 00:00 [received] PHST- 2021/07/14 00:00 [revised] PHST- 2021/07/15 00:00 [accepted] PHST- 2021/07/24 01:07 [entrez] PHST- 2021/07/25 06:00 [pubmed] PHST- 2021/07/25 06:01 [medline] PHST- 2021/07/19 00:00 [pmc-release] AID - jcm10143177 [pii] AID - jcm-10-03177 [pii] AID - 10.3390/jcm10143177 [doi] PST - epublish SO - J Clin Med. 2021 Jul 19;10(14):3177. doi: 10.3390/jcm10143177.