PMID- 38370239 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240220 IS - 2405-8440 (Print) IS - 2405-8440 (Electronic) IS - 2405-8440 (Linking) VI - 10 IP - 4 DP - 2024 Feb 29 TI - Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis. PG - e25357 LID - 10.1016/j.heliyon.2024.e25357 [doi] LID - e25357 AB - BACKGROUND: Biologic or small-molecule therapies are highly effective for the treatment of inflammatory bowel disease (IBD), and approval by the FDA has significantly increased both their clinical use and the development of novel regimens. However, the identification and management of their associated toxicities poses challenges for clinicians and researchers. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) published from January 1, 2000, to October 15, 2022, and in the databases. A random-effects model with logit transformation was applied to the analysis heterogeneity between studies was evaluated using the I(2) statistic with incidence and 95 % confidence interval (CI) for any adverse events (AEs), and serious AEs (SAEs). RESULTS: In Crohn's disease (CD), the total AE incidence was 67.0 % (95 % CI, 66.2%-67.8 %; I(2) = 97.2 %) for any AEs and 7.3 % (6.9-7.7; 97.2) for serious AEs. In ulcerative colitis (UC), the overall incidence of any and serious AEs was 63.6 % (63.0-64.3; 98.1) and 5.7 % (5.4-6.0; 88.9), respectively. The most common AEs were infections (21.5 [20.3-22.8], 32.6 [31.0-34.2], 25.9 [24.5-27.2], and 13.7 [10.7-16.7]) in CD patients that were treated with TNF antagonists, anti-integrins, anti-IL agents, and JAK inhibitors, respectively, and in UC patients also were infections (22.8 [21.7-24.0], 27.4 [25.9-28.9], and 18.4 [16.7-20.2]), respectively, as well as increases in lactic dehydrogenase levels (23.1 [20.8-25.4]) with JAK inhibitors. CONCLUSION: This study offers a comprehensive summary of toxic side effects of IBD treatments and a useful reference for both patients and clinicians. CI - (c)2024PublishedbyElsevierLtd. FAU - Wang, Kailing AU - Wang K AD - Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. FAU - Zhu, Youwen AU - Zhu Y AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. FAU - Liu, Kun AU - Liu K AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. FAU - Zhu, Hong AU - Zhu H AD - Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. AD - National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. FAU - Ouyang, Miao AU - Ouyang M AD - Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. AD - National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China. LA - eng PT - Journal Article DEP - 20240208 PL - England TA - Heliyon JT - Heliyon JID - 101672560 PMC - PMC10869791 OTO - NOTNLM OT - Adverse events OT - Biologic therapies OT - Clinical trials OT - Inflammatory bowel disease OT - Target agents COIS- The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2024/02/19 06:42 MHDA- 2024/02/19 06:43 PMCR- 2024/02/08 CRDT- 2024/02/19 04:08 PHST- 2023/03/19 00:00 [received] PHST- 2023/09/20 00:00 [revised] PHST- 2024/01/25 00:00 [accepted] PHST- 2024/02/19 06:43 [medline] PHST- 2024/02/19 06:42 [pubmed] PHST- 2024/02/19 04:08 [entrez] PHST- 2024/02/08 00:00 [pmc-release] AID - S2405-8440(24)01388-4 [pii] AID - e25357 [pii] AID - 10.1016/j.heliyon.2024.e25357 [doi] PST - epublish SO - Heliyon. 2024 Feb 8;10(4):e25357. doi: 10.1016/j.heliyon.2024.e25357. eCollection 2024 Feb 29.