School of Health and Medical Sciences, Örebro University, Örebro, Sweden.
Central Hospital in Karlstad, Karlstad, Sweden.
Dig Dis Sci. 2024 Jun;69(6):2175-2183. doi: 10.1007/s10620-024-08422-9. Epub 2024 Apr 18.
Real-world data on starting intravenous (IV) vedolizumab (VDZ) and transitioning to subcutaneous (SC) treatment in inflammatory bowel disease (IBD) are scarce.
To assess treatment outcomes of patients with IBD starting IV VDZ and switching to SC VDZ in routine clinical care.
Adult patients with IBD switching from IV to SC VDZ treatment between 1 March 2020 and 31 December 2021 were identified from the Swedish IBD quality register. The primary outcome was SC VDZ persistence. Secondary outcomes included clinical remission, changes in quality of life (QoL) according to EuroQual 5-Dimensions 5-Levels (EQ-5D-5L) and the Short-Health Scale (SHS) and inflammatory markers, including faecal Calprotectin (FCP).
Altogether, 406 patients with IBD (Crohn's disease, n = 181; ulcerative colitis, n = 225) were identified. After a median follow-up of 30 months from starting IV VDZ treatment, the persistence rates were 98%(178/181) in Crohn's disease and 94% (211/225) in ulcerative colitis. Most patients (84%) transitioned during maintenance therapy, and the median follow-up from switch to SC VDZ was 10 months. Compared to baseline, statistically significant improvements were observed in all domains of the SHS, EQ-5D index value and visual analogue scale. Median (interquartile range) FCP concentrations (μg/g) decreased from 459 (185-1001) to 65 (26-227) in Crohn's disease (n = 45; p < 0.001) and from 646 (152-1450) to 49 (20-275) in ulcerative colitis (n = 58; p < 0.001).
Initiating IV VDZ and switching to SC treatment was associated with high persistence rates and improvements in measures of QoL and FCP. These findings are reassuring for patients who start IV VDZ and switch to SC VDZ.
在炎症性肠病(IBD)中,关于开始静脉(IV)维多珠单抗(VDZ)和转为皮下(SC)治疗的真实数据很少。
评估在常规临床护理中开始 IV VDZ 并转为 SC VDZ 治疗的 IBD 患者的治疗结果。
从瑞典 IBD 质量登记处确定了 2020 年 3 月 1 日至 2021 年 12 月 31 日期间从 IV 转为 SC VDZ 治疗的 IBD 成年患者。主要结局是 SC VDZ 持续时间。次要结局包括临床缓解、根据 EuroQual 5-Dimensions 5-Levels(EQ-5D-5L)和 Short-Health Scale(SHS)评估的生活质量(QoL)变化以及炎症标志物,包括粪便钙卫蛋白(FCP)。
共确定了 406 名 IBD 患者(克罗恩病,n=181;溃疡性结肠炎,n=225)。从开始 IV VDZ 治疗到中位随访 30 个月后,克罗恩病的持续率为 98%(178/181),溃疡性结肠炎为 94%(211/225)。大多数患者(84%)在维持治疗期间进行了转换,从转换到 SC VDZ 到中位随访时间为 10 个月。与基线相比,SHS 的所有领域、EQ-5D 指数值和视觉模拟量表均有显著改善。克罗恩病(n=45)的中位数(四分位距)FCP 浓度(μg/g)从 459(185-1001)降至 65(26-227)(p<0.001),溃疡性结肠炎(n=58)从 646(152-1450)降至 49(20-275)(p<0.001)。
开始 IV VDZ 并转为 SC 治疗与高持续率以及 QoL 和 FCP 测量值的改善相关。这些发现对于开始 IV VDZ 并转为 SC VDZ 的患者来说是令人放心的。