METHODS: Single-center retrospective review of patients receiving GMA+VDZ. Data on the disease and previous treatments were collected. Clinical response was classified as no response, response without remission, and remission. Available data on biochemical and endoscopic response were included. Adverse events (AEs) were recorded.
RESULTS: The study population comprised 6 patients with UC who had received GMA+VDZ during induction after failure of an anti-TNF agent. The median number of GMA sessions was 5 (IQR 4-5; 3-10). All the patients received VDZ 300mg iv at 0, 2, and 6 weeks, and 5 (83%) received an additional dose at week 10. During maintenance, all the patients continued VDZ iv every 8 weeks. The median follow-up was 57.6 months (IQR: 39-74). Four of the 6 patients achieved clinical remission after GMA+VDZ and continued in deep remission until the end of follow-up. A median, non-significant decrease of 1378μg/g (IQR: 924-5778μg/g) was observed for calprotectin and 42.2mg/l (IQR: 15.3-113.5) for CRP vs. baseline. No patient underwent colectomy. No treatment-related AEs were observed.
CONCLUSIONS: GMA+VDZ during induction can be effective and safe in selected patients with moderate-severe UC and partial response to steroids.
方法:单中心回顾性分析GMA+VDZ患者。收集疾病和先前治疗的数据。临床反应被归类为无反应,没有缓解的反应,和缓解。包括有关生化和内镜反应的可用数据。记录不良事件(AE)。
结果:研究人群包括6名UC患者,他们在抗TNF药物失败后的诱导过程中接受了GMA+VDZ。GMA会议的中位数为5(IQR4-5;3-10)。所有患者在第0、2和6周静脉注射VDZ300mg,和5(83%)在第10周接受了额外的剂量。在维护期间,所有患者每8周继续静脉输注VDZ.中位随访时间为57.6个月(IQR:39-74)。6例患者中有4例在GMA+VDZ后达到临床缓解,并持续深度缓解直至随访结束。中位数,观察到钙卫蛋白和CRP的无明显下降1378µg/g(IQR:924-5778µg/g)和42.2mg/l(IQR:15.3-113.5)基线无患者行结肠切除术。未观察到治疗相关的AE。
结论:诱导期间GMA+VDZ对中重度UC和对类固醇有部分反应的患者是有效和安全的。