Amor Costa Carmen, Suárez Ferrer Cristina, García Ramírez Laura, Martín-Arranz Eduardo, Poza Cordón Joaquín, Rueda García José Luis, Sánchez Azofra María, González Diaz Irene, Amiama Roig Clara, Martín-Arranz María Dolores
Servicio de Aparato Digestivo, Hospital Universitario La Paz, Madrid, España.
Servicio de Aparato Digestivo, Hospital Universitario La Paz, Madrid, España; Instituto de Investigación Sanitaria, Hospital Universitario La Paz-IdiPAZ, Madrid, España.
Gastroenterol Hepatol. 2025 Mar;48(3):502201. doi: 10.1016/j.gastrohep.2024.502201. Epub 2024 May 7.
The aim of the study is to evaluate the clinical and biochemical response of inflammatory bowel disease patients treated with vedolizumab, 16 weeks after transitioning from intravenous (iv) to subcutaneous (sc).
An observational, prospective, single-center cohort study was performed. Patients with inflammatory bowel disease and maintenance treatment with vedolizumab, stable for at least 4 months, 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.
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 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 week 16 were higher in the sc group (22,364.3±5141.6) vs. iv (11,425.9±1514.2) (p=0.009). At week 16, 9 (75%) of the patients in the sc group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. Four 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.
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.
本研究旨在评估维多珠单抗从静脉注射（iv）转换为皮下注射（sc）16周后，炎症性肠病患者的临床和生化反应。
进行了一项观察性、前瞻性、单中心队列研究。患有炎症性肠病且接受维多珠单抗维持治疗至少4个月且病情稳定的患者被提供转换为皮下注射制剂。在给药治疗的同时进行血液检查，检测维多珠单抗水平和粪便钙卫蛋白。
纳入43例患者，其中12例（27.9%）选择转换为皮下注射制剂。所有纳入患者在随访期间均保持缓解。在第16周时，静脉注射治疗的患者（平均146.6±标准差45.9）与皮下注射治疗的患者（159.26±53.9）相比，钙卫蛋白水平无显著差异（p=0.9）。皮下注射组在第16周时的维多珠单抗血清水平（22,364.3±5141.6）高于静脉注射组（11,425.9±1514.2）（p=0.009）。在第16周时，皮下注射组9例（75%）患者对药物高度满意，11例（91.7%）认为给药容易。静脉注射组4例（12.9%）患者和皮下注射组2例（16.6%）患者出现轻度不良反应。皮下注射组的2例（100%）不良事件为注射部位局部炎症。
根据我们的经验，皮下注射维多珠单抗是静脉注射给药的便捷替代方案。转换为皮下注射的患者的维多珠单抗血清水平高于静脉注射制剂。
