共 56 条
IL-17 inhibitor-associated inflammatory bowel disease: A study based on literature and database analysis
被引:60
作者:

Deng, Zhenzhen
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Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China

Wang, Shengfeng
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Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China

Wu, Cuifang
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Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China

Wang, Chunjiang
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Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China
机构:
[1] Cent South Univ, Xiangya Hosp 3, Dept Pharm, Changsha, Hunan, Peoples R China
关键词:
IL-17;
inhibitors;
inflammatory bowel disease;
FAERS database;
pharmacovigilance;
drug safety;
PSORIATIC-ARTHRITIS;
ULCERATIVE-COLITIS;
PLAQUE PSORIASIS;
CROHNS-DISEASE;
SECUKINUMAB;
INTERLEUKIN-17;
PATIENT;
ONSET;
D O I:
10.3389/fphar.2023.1124628
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
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.
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机构:
Humanitas Univ, Dept Biomed Sci, Milan, Italy
Humanitas Res Hosp, Dept Gastroenterol, Milan, Italy Univ Hosp Nancy, Rheumatol Dept, Nancy, Meurthe Moselle, France

Loeuille, Damien
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机构:
Univ Hosp Nancy, Rheumatol Dept, Nancy, Meurthe Moselle, France
Univ Lorraine, Ingn Mol & Ingn Articulaire IMoPA, UMR 7365, CNRS, Nancy, France
Univ Hosp Nancy, Nancy, France Univ Hosp Nancy, Rheumatol Dept, Nancy, Meurthe Moselle, France

Peyrin-Biroulet, Laurent
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Univ Lorraine, Nancy Univ Hosp, Dept Gastroenterol, Vandoeuvre Les Nancy, France
Univ Lorraine, Nancy Univ Hosp, INSERM, NGERE U1256, Vandoeuvre Les Nancy, France Univ Hosp Nancy, Rheumatol Dept, Nancy, Meurthe Moselle, France