IL-17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase
IL-17 Inhibitors and Inflammatory Bowel Diseases: A Postmarketing Study in Vigibase
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DOI：
10.1002/cpt.2155
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发表时间：
2021-02-12
影响因子：
6.7
通讯作者：
Gillet, Pierre
中科院分区：
文献类型：
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作者：
Petitpain, Nadine;D'Amico, Ferdinando;Gillet, Pierre
据报道，在使用IL-17抑制剂治疗后，出现了一些胃肠道症状和慢性炎症性肠病(IBD)。然而，到目前为止，还没有研究表明这些药物与IBD发病之间存在明确的联系。我们在全球药物警戒数据库Vigibase上搜索，以调查接受IL-17抑制剂治疗的患者所有胃肠道不良事件的报告患病率、特征和预后。总共确定了1129份胃肠道个体病例安全报告(ICSR)，其中包括850例IBD(42.5%的克罗恩病、31.9%的溃疡性结肠炎和25.6%的未分化IBD)和279例结肠炎(主要是未分化结肠炎(79.2%)和镜检结肠炎(10.4%))。ICSR与Suckinumab(SEC，83.6%)或Ixekizumab(IXe，16.3%)相关，而只有一例结肠炎与Brodalab(0.1%)有关。在SEC(68.8%和73.5%)和IXe组(100%和66.7%)中，大多数IBD和结肠炎病例都是在治疗开始后6个月内发现的。在428个ICSR中报告了患者的结果(37.9%)。在经历IBD(59.5%)或结肠炎(64.2%)的患者中，约有三分之二的患者症状完全或持续恢复，而在其他患者中，没有恢复(33.9%和29.5%)或有后遗症(5.4%和4.2%)。在IBD组中有4名患者(1.2%)发生致命事件(3例在服用SEC后，仅在服用IXe后)，在结肠炎组中有2名接受SEC治疗的受试者(2.1%)。使用IL-17抑制剂的治疗与相应数量的IBD和结肠炎的恶化和新的发病有关。在处方这些药物之前，应建议仔细评估胃肠道症状和监测肠道炎症生物标志物。
Several gastrointestinal symptoms and chronic inflammatory bowel diseases (IBDs) have been reported after therapy with IL-17 inhibitors. To date, however, no study has shown a clear association between these drugs and IBD onset. We searched on Vigibase, the worldwide pharmacovigilance database, to investigate reporting prevalence, characteristics, and prognosis of all gastroenterological adverse events in patients treated with IL-17 inhibitors. In total, 1,129 gastrointestinal Individual Case Safety Reports (ICSRs) were identified, including 850 IBD (42.5% Crohn's disease, 31.9% ulcerative colitis, and 25.6% undifferentiated IBD) and 279 colitis (mainly undifferentiated colitis (79.2%), and microscopic colitis (10.4%)). ICSRs were associated with secukinumab (SEC, 83.6%) or ixekizumab (IXE, 16.3%), whereas only one colitis occurred with brodalumab (0.1%). Most IBD and colitis cases were detected within 6 months from therapy start in both the SEC (68.8% and 73.5%) and IXE groups (100% and 66.7%). Patients' outcomes were reported in 428 ICSRs (37.9%). Complete or ongoing recovery from symptoms was detected in about two-thirds of patients experiencing IBD (59.5%) or colitis (64.2%), whereas in the other cases, there was no recovery (33.9% and 29.5%) or there were sequelae (5.4% and 4.2%). Fatal events occurred in four patients (1.2%) in the IBD group (3 after SEC and on1e with IXE) and two SEC-treated subjects in the colitis group (2.1%). Treatment with IL-17 inhibitors is associated with a relevant number of exacerbations and new onset of IBD and colitis. Careful evaluation of gastrointestinal symptoms and the monitoring of intestinal inflammatory biomarkers should be recommended before prescribing these drugs.