{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:37:01Z","timestamp":1759970221936,"version":"build-2065373602"},"reference-count":98,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,1,11]],"date-time":"2025-01-11T00:00:00Z","timestamp":1736553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background\/Objectives: The introduction of anti-tumor necrosis factor-\u03b1 (anti-TNF-\u03b1) 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. Methods: This retrospective, single-center study examined pediatric IBD patients receiving anti-TNF-\u03b1 therapy at the \u201cGrigore Alexandrescu\u201d 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\u2013Barr\u00e9 syndrome), and infections. AEs were analyzed in relation to the specific anti-TNF-\u03b1 agent administered and comprehensively characterized. Results: Of 40 patients enrolled, 22 (55%) had Crohn\u2019s disease (CD). The median (IQR) age at diagnosis was 14.8 years [10.8\u201315.9]. 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, p = 0.01. Conclusions: 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-\u03b1 therapy in pediatric IBD management.<\/jats:p>","DOI":"10.3390\/ph18010084","type":"journal-article","created":{"date-parts":[[2025,1,13]],"date-time":"2025-01-13T09:49:17Z","timestamp":1736761757000},"page":"84","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Anti-Tumor Necrosis Factor-\u03b1 Use in Pediatric Inflammatory Bowel Disease\u2014Reports from a Romanian Center"],"prefix":"10.3390","volume":"18","author":[{"given":"Roxana","family":"Matran","sequence":"first","affiliation":[{"name":"Department of Paediatrics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, 050474 Bucharest, Romania"},{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0763-7107","authenticated-orcid":false,"given":"Andra-Mihaela","family":"Diaconu","sequence":"additional","affiliation":[{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreea Maria","family":"Iordache","sequence":"additional","affiliation":[{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5814-2082","authenticated-orcid":false,"given":"Irina","family":"Dijm\u0103rescu","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, 050474 Bucharest, Romania"},{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0785-1214","authenticated-orcid":false,"given":"Alexandra","family":"Coroleuc\u0103","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, 050474 Bucharest, Romania"},{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8604-8691","authenticated-orcid":false,"given":"Daniela","family":"P\u0103curar","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, 050474 Bucharest, Romania"},{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Becheanu","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, 050474 Bucharest, Romania"},{"name":"\u201cGrigore Alexandrescu\u201d Emergency Hospital for Children, 011743 Bucharest, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Liu, C., Yu, R., Zhang, J., Wei, S., Xue, F., Guo, Y., He, P., Shang, L., and Dong, W. 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