Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis
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 associat...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-02-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844024013884 |
| _version_ | 1797267814464094208 |
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| author | Kailing Wang Youwen Zhu Kun Liu Hong Zhu Miao Ouyang |
| author_facet | Kailing Wang Youwen Zhu Kun Liu Hong Zhu Miao Ouyang |
| author_sort | Kailing Wang |
| collection | DOAJ |
| description | 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 I2 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 %; I2 = 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. |
| first_indexed | 2024-03-08T03:30:23Z |
| format | Article |
| id | doaj.art-7aa645da59e44739b44e9971a58dd8df |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-04-25T01:22:34Z |
| publishDate | 2024-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-7aa645da59e44739b44e9971a58dd8df2024-03-09T09:25:22ZengElsevierHeliyon2405-84402024-02-01104e25357Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysisKailing Wang0Youwen Zhu1Kun Liu2Hong Zhu3Miao Ouyang4Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, ChinaDepartment of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, ChinaDepartment of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, ChinaDepartment of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China; Corresponding author. Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.Department of Gastroenterology, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China; Corresponding author. Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.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 I2 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 %; I2 = 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.http://www.sciencedirect.com/science/article/pii/S2405844024013884Biologic therapiesTarget agentsInflammatory bowel diseaseClinical trialsAdverse events |
| spellingShingle | Kailing Wang Youwen Zhu Kun Liu Hong Zhu Miao Ouyang Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis Heliyon Biologic therapies Target agents Inflammatory bowel disease Clinical trials Adverse events |
| title | Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis |
| title_full | Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis |
| title_fullStr | Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis |
| title_full_unstemmed | Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis |
| title_short | Adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease: A systematic review and meta-analysis |
| title_sort | adverse events of biologic or small molecule therapies in clinical trials for inflammatory bowel disease a systematic review and meta analysis |
| topic | Biologic therapies Target agents Inflammatory bowel disease Clinical trials Adverse events |
| url | http://www.sciencedirect.com/science/article/pii/S2405844024013884 |
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