炎症性肠病患者从静脉注射到皮下注射vedolizumab的过渡评估

Carmen Amor Costa , Cristina Suárez Ferrer , Laura García Ramírez , Eduardo Martín-Arranz , Joaquín Poza Cordón , José Luis Rueda García , María Sánchez Azofra , Irene González Diaz , Clara Amiama Roig , María Dolores Martín-Arranz
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引用次数: 0

摘要

该研究的目的是评估炎症性肠病(IBD)患者在从静脉注射(iv)过渡到皮下注射(sc) 16周后接受vedolizumab治疗的临床和生化反应。方法采用观察性、前瞻性、单中心队列研究。IBD患者和维多单抗维持治疗,稳定至少4个月,建议切换到sc制剂。在给予治疗的同时进行血液检查,检查维多珠单抗水平和粪便钙保护蛋白。结果纳入43例患者,其中12例(27.9%)选择改用sc制剂。所有纳入的患者在随访期间均保持缓解。在第16周(w16),静脉注射治疗患者的钙保护蛋白水平(平均146.6±SD 45.9)与sc(159.26±53.9)没有显著差异(p 0.9)。在w16时,sc组Vedolizumab血清水平(22364.3±5141.6)高于iv组(11425.9±1514.2)(p 0.009)。在w16时,SC组中有9名(75%)患者对用药高度满意,11名(91.7%)患者认为用药容易。iv组4例(12.9%),sc组2例(16.6%)出现轻度不良反应。sc组2例(100%)不良反应为注射部位局部炎症。结论根据我们的经验,vedolizumab sc是静脉给药的一种方便的替代方案。过渡到sc的患者的Vedolizumab血清水平高于静脉制剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease

Aims

The aim of the study is to evaluate the clinical and biochemical response of inflammatory bowel disease (IBD) patients treated with vedolizumab, 16 weeks after transitioning from intravenous (iv) to subcutaneous (sc).

Methods

An observational, prospective, single-center cohort study was performed. Patients with IBD and maintenance treatment with vedolizumab, stable for at least 4 mo, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin.

Results

Forty-three patients were included, 12 of them (27.9%) chose to transition to sc formulation. All included patients remained in remission during follow-up. At week 16 (w16), no significant differences were found in terms of calprotectin levels in patients on iv treatment (mean 146.6 ± SD 45.9) vs. sc (159.26 ± 53.9) (p 0.9). Vedolizumab serum levels at w16 were higher in the sc group (22364.3 ± 5141.6) vs. iv (11425.9 ± 1514.2) (p 0.009). At w16, 9 (75%) of the patients in the SC group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. 4 patients (12.9%) in the iv group and 2 (16.6%) in the sc group presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site.

Conclusion

In our experience, vedolizumab sc is a convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.
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