IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis
Objective: Few real-world studies have shown clear association between interleukin (IL)-17 inhibitors and inflammatory bowel disease (IBD) onset. This study investigated the reporting prevalence and evaluated the clinical features and management of IL-17 inhibitor-related IBD events.Methods: We used...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-03-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1124628/full |
| _version_ | 1827981788293627904 |
|---|---|
| author | Zhenzhen Deng Shengfeng Wang Cuifang Wu Chunjiang Wang |
| author_facet | Zhenzhen Deng Shengfeng Wang Cuifang Wu Chunjiang Wang |
| author_sort | Zhenzhen Deng |
| collection | DOAJ |
| description | Objective: Few real-world studies have shown clear association between interleukin (IL)-17 inhibitors and inflammatory bowel disease (IBD) onset. This study investigated the reporting prevalence and evaluated the clinical features and management of IL-17 inhibitor-related IBD events.Methods: We used the US FDA Adverse Event Reporting System database and retrieved data, from 2015 to 2022, on IL-17 inhibitors to identify gastrointestinal inflammatory events and conduct disproportionality analyses by estimating the reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs). Furthermore, case reports and case series, from 2015 to 30 November 2022, on IBD induced by IL-17 inhibitors were collected for retrospective analysis.Results: A total of 388 cases of primary suspected IL-17 inhibitor-associated gastrointestinal events were reported (268 IBD and 120 colitis), including 348 cases involving secukinumab (SEC), 36 cases involving ixekizumab (IXE), and 4 cases involving brodalumab (BRO). Statistically significant reporting rates of total IBD events were observed for SEC and IXE (ROR = 2.13, 95% CI [1.96-2.30] and ROR = 2.79, 95% CI [2.39-3.27], respectively), whereas BRO did not trigger a safety signal. Twenty-nine studies, which included 34 cases, showed evidence of IBD, following SEC (79.4%) and IXE (20.6%) treatment. The median age was 42 years; typical initial symptoms included diarrhea (90.9%), abdominal pain (57.6%), bloody diarrhea (51.5%), and fever (36.4%). The median time to onset of IBD symptoms was 2.9 months. Some cases were accompanied by elevated white blood cell (WBC) count (87.5%), erythrocyte sedimentation rate (ESR; 85.7%), C-reactive protein (CRP; 100%), and fecal calprotectin (FC; 100%). Cessation of IL-17 inhibitors plus treatment with corticosteroids and TNF antagonists, as either monotherapy or in combination, could lead to complete clinical remission. The median time to remission after IL-17 inhibitor discontinuation was 4 weeks.Conclusion: IL-17 inhibitor treatment is associated with exacerbation and new onset of IBD and colitis. Obtaining a detailed patient history before initiation of treatment and monitoring gastrointestinal symptoms and intestinal inflammatory biomarkers during IL-17 inhibitor treatment is important for safe use of these drugs. |
| first_indexed | 2024-04-09T22:14:36Z |
| format | Article |
| id | doaj.art-f5e9a6f379014e2796c3254cf658f196 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-09T22:14:36Z |
| publishDate | 2023-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-f5e9a6f379014e2796c3254cf658f1962023-03-23T05:27:31ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-03-011410.3389/fphar.2023.11246281124628IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysisZhenzhen DengShengfeng WangCuifang WuChunjiang WangObjective: Few real-world studies have shown clear association between interleukin (IL)-17 inhibitors and inflammatory bowel disease (IBD) onset. This study investigated the reporting prevalence and evaluated the clinical features and management of IL-17 inhibitor-related IBD events.Methods: We used the US FDA Adverse Event Reporting System database and retrieved data, from 2015 to 2022, on IL-17 inhibitors to identify gastrointestinal inflammatory events and conduct disproportionality analyses by estimating the reporting odds ratios (RORs) and corresponding 95% confidence intervals (CIs). Furthermore, case reports and case series, from 2015 to 30 November 2022, on IBD induced by IL-17 inhibitors were collected for retrospective analysis.Results: A total of 388 cases of primary suspected IL-17 inhibitor-associated gastrointestinal events were reported (268 IBD and 120 colitis), including 348 cases involving secukinumab (SEC), 36 cases involving ixekizumab (IXE), and 4 cases involving brodalumab (BRO). Statistically significant reporting rates of total IBD events were observed for SEC and IXE (ROR = 2.13, 95% CI [1.96-2.30] and ROR = 2.79, 95% CI [2.39-3.27], respectively), whereas BRO did not trigger a safety signal. Twenty-nine studies, which included 34 cases, showed evidence of IBD, following SEC (79.4%) and IXE (20.6%) treatment. The median age was 42 years; typical initial symptoms included diarrhea (90.9%), abdominal pain (57.6%), bloody diarrhea (51.5%), and fever (36.4%). The median time to onset of IBD symptoms was 2.9 months. Some cases were accompanied by elevated white blood cell (WBC) count (87.5%), erythrocyte sedimentation rate (ESR; 85.7%), C-reactive protein (CRP; 100%), and fecal calprotectin (FC; 100%). Cessation of IL-17 inhibitors plus treatment with corticosteroids and TNF antagonists, as either monotherapy or in combination, could lead to complete clinical remission. The median time to remission after IL-17 inhibitor discontinuation was 4 weeks.Conclusion: IL-17 inhibitor treatment is associated with exacerbation and new onset of IBD and colitis. Obtaining a detailed patient history before initiation of treatment and monitoring gastrointestinal symptoms and intestinal inflammatory biomarkers during IL-17 inhibitor treatment is important for safe use of these drugs.https://www.frontiersin.org/articles/10.3389/fphar.2023.1124628/fullIL-17 inhibitorsinflammatory bowel diseaseFAERS databasepharmacovigilancedrug safety |
| spellingShingle | Zhenzhen Deng Shengfeng Wang Cuifang Wu Chunjiang Wang IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis Frontiers in Pharmacology IL-17 inhibitors inflammatory bowel disease FAERS database pharmacovigilance drug safety |
| title | IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis |
| title_full | IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis |
| title_fullStr | IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis |
| title_full_unstemmed | IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis |
| title_short | IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis |
| title_sort | il 17 inhibitor associated inflammatory bowel disease a study based on literature and database analysis |
| topic | IL-17 inhibitors inflammatory bowel disease FAERS database pharmacovigilance drug safety |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1124628/full |
| work_keys_str_mv | AT zhenzhendeng il17inhibitorassociatedinflammatoryboweldiseaseastudybasedonliteratureanddatabaseanalysis AT shengfengwang il17inhibitorassociatedinflammatoryboweldiseaseastudybasedonliteratureanddatabaseanalysis AT cuifangwu il17inhibitorassociatedinflammatoryboweldiseaseastudybasedonliteratureanddatabaseanalysis AT chunjiangwang il17inhibitorassociatedinflammatoryboweldiseaseastudybasedonliteratureanddatabaseanalysis |