Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center
<b>Background/Objectives:</b> The introduction of anti-tumor necrosis factor-α (anti-TNF-α) agents, particularly infliximab (IFX) and adalimumab (ADA), has significantly expanded the therapeutic arsenal for inflammatory bowel disease (IBD). While these biologics have demonstrated substan...
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2025-01-01
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| author | Roxana Matran Andra-Mihaela Diaconu Andreea Maria Iordache Irina Dijmărescu Alexandra Coroleucă Daniela Păcurar Cristina Becheanu |
| author_facet | Roxana Matran Andra-Mihaela Diaconu Andreea Maria Iordache Irina Dijmărescu Alexandra Coroleucă Daniela Păcurar Cristina Becheanu |
| author_sort | Roxana Matran |
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| description | <b>Background/Objectives:</b> The introduction of anti-tumor necrosis factor-α (anti-TNF-α) agents, particularly infliximab (IFX) and adalimumab (ADA), has significantly expanded the therapeutic arsenal for inflammatory bowel disease (IBD). While these biologics have demonstrated substantial efficacy, they are associated with a spectrum of potential adverse events (AEs). This study aims to evaluate and document these AEs to facilitate optimal patient selection and monitoring strategies of patients undergoing these therapies. <b>Methods</b>: This retrospective, single-center study examined pediatric IBD patients receiving anti-TNF-α therapy at the “Grigore Alexandrescu” Emergency Hospital for Children in Bucharest, Romania, from January 2015 to October 2024. AEs were categorized into non-infectious complications (acute infusion reactions, anti-drug antibody formation), dermatological effects (erythema nodosum, vasculitis), neurological effects (Guillain–Barré syndrome), and infections. AEs were analyzed in relation to the specific anti-TNF-α agent administered and comprehensively characterized. <b>Results</b>: Of 40 patients enrolled, 22 (55%) had Crohn’s disease (CD). The median (IQR) age at diagnosis was 14.8 years [10.8–15.9]. IFX was used in 34 (85%) patients while 6 (15%) patients received either ADA or IFX/ADA sequential therapy. Twenty-seven AEs were documented in 19 (47.5%) patients, the most prevalent being antidrug antibody formation (44.4%), infections (22.2%), and acute infusion reactions (22.2%). All ADA-exposed patients experienced at least one AE, compared to 41.2% (n = 14) patients treated with IFX, <i>p</i> = 0.01. <b>Conclusions</b>: AEs were observed in approximately half of the study cohort, with anti-drug antibody formation emerging as the most frequent complication. ADA therapy was associated with a significantly higher rate of AEs compared to IFX. These findings underscore the critical importance of vigilant monitoring for patients undergoing anti-TNF-α therapy in pediatric IBD management. |
| format | Article |
| id | doaj-art-0cca925a88414b6fa92558f63c61c69e |
| institution | Kabale University |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-0cca925a88414b6fa92558f63c61c69e2025-01-24T13:45:20ZengMDPI AGPharmaceuticals1424-82472025-01-011818410.3390/ph18010084Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian CenterRoxana Matran0Andra-Mihaela Diaconu1Andreea Maria Iordache2Irina Dijmărescu3Alexandra Coroleucă4Daniela Păcurar5Cristina Becheanu6Department of Paediatrics, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, Romania“Grigore Alexandrescu” Emergency Hospital for Children, 011743 Bucharest, Romania“Grigore Alexandrescu” Emergency Hospital for Children, 011743 Bucharest, RomaniaDepartment of Paediatrics, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, RomaniaDepartment of Paediatrics, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, RomaniaDepartment of Paediatrics, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, RomaniaDepartment of Paediatrics, “Carol Davila” University of Medicine and Pharmacy, 050474 Bucharest, Romania<b>Background/Objectives:</b> The introduction of anti-tumor necrosis factor-α (anti-TNF-α) agents, particularly infliximab (IFX) and adalimumab (ADA), has significantly expanded the therapeutic arsenal for inflammatory bowel disease (IBD). While these biologics have demonstrated substantial efficacy, they are associated with a spectrum of potential adverse events (AEs). This study aims to evaluate and document these AEs to facilitate optimal patient selection and monitoring strategies of patients undergoing these therapies. <b>Methods</b>: This retrospective, single-center study examined pediatric IBD patients receiving anti-TNF-α therapy at the “Grigore Alexandrescu” Emergency Hospital for Children in Bucharest, Romania, from January 2015 to October 2024. AEs were categorized into non-infectious complications (acute infusion reactions, anti-drug antibody formation), dermatological effects (erythema nodosum, vasculitis), neurological effects (Guillain–Barré syndrome), and infections. AEs were analyzed in relation to the specific anti-TNF-α agent administered and comprehensively characterized. <b>Results</b>: Of 40 patients enrolled, 22 (55%) had Crohn’s disease (CD). The median (IQR) age at diagnosis was 14.8 years [10.8–15.9]. IFX was used in 34 (85%) patients while 6 (15%) patients received either ADA or IFX/ADA sequential therapy. Twenty-seven AEs were documented in 19 (47.5%) patients, the most prevalent being antidrug antibody formation (44.4%), infections (22.2%), and acute infusion reactions (22.2%). All ADA-exposed patients experienced at least one AE, compared to 41.2% (n = 14) patients treated with IFX, <i>p</i> = 0.01. <b>Conclusions</b>: AEs were observed in approximately half of the study cohort, with anti-drug antibody formation emerging as the most frequent complication. ADA therapy was associated with a significantly higher rate of AEs compared to IFX. These findings underscore the critical importance of vigilant monitoring for patients undergoing anti-TNF-α therapy in pediatric IBD management.https://www.mdpi.com/1424-8247/18/1/84inflammatory bowel diseaseanti-TNF-αantidrug antibodiesacute-infusion reactionsadverse events |
| spellingShingle | Roxana Matran Andra-Mihaela Diaconu Andreea Maria Iordache Irina Dijmărescu Alexandra Coroleucă Daniela Păcurar Cristina Becheanu Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center Pharmaceuticals inflammatory bowel disease anti-TNF-α antidrug antibodies acute-infusion reactions adverse events |
| title | Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center |
| title_full | Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center |
| title_fullStr | Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center |
| title_full_unstemmed | Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center |
| title_short | Anti-Tumor Necrosis Factor-α Use in Pediatric Inflammatory Bowel Disease—Reports from a Romanian Center |
| title_sort | anti tumor necrosis factor α use in pediatric inflammatory bowel disease reports from a romanian center |
| topic | inflammatory bowel disease anti-TNF-α antidrug antibodies acute-infusion reactions adverse events |
| url | https://www.mdpi.com/1424-8247/18/1/84 |
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