Huang Kaituo, Yao Lingya, Liu Jing, Cao Qian
Department of Gastroenterology, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Inflammatory Bowel Disease Center of Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Ther Adv Chronic Dis. 2024 May 8;15:20406223241247648. doi: 10.1177/20406223241247648. eCollection 2024.
In 2020, the European Medicines Agency approved subcutaneous (SC) vedolizumab (VDZ) for the maintenance treatment of adult patients with moderate to severe inflammatory bowel disease (IBD). This article reviews the efficacy, safety, persistence, pharmacology, patient satisfaction, and economic implications of transitioning to SC VDZ treatment and explores whether SC formulations can be recommended by the same guidelines as intravenous (IV) formulations. Clinical trials and real-world evidence indicate that transitioning from IV to SC VDZ in patients with IBD maintains clinical, biochemical, and patient-reported clinical remission and is well-tolerated, with no new safety issues identified, except for injection site reactions. Moreover, SC VDZ has an exposure-response relationship and low immunogenicity, is economical, and provides a high level of patient satisfaction. Owing to these advantages, transitioning may be advisable. In the future, more studies are needed to clarify the exact role of SC VDZ in IBD treatment, including optimization and transitioning strategies and individualized treatments based on baseline characteristics.
2020年，欧洲药品管理局批准皮下注射维多珠单抗（VDZ）用于中重度炎症性肠病（IBD）成年患者的维持治疗。本文综述了转换为皮下注射VDZ治疗的疗效、安全性、持续性、药理学、患者满意度及经济影响，并探讨皮下注射剂型是否能与静脉注射（IV）剂型遵循相同的指南推荐。临床试验和真实世界证据表明，IBD患者从静脉注射转换为皮下注射VDZ可维持临床、生化及患者报告的临床缓解，且耐受性良好，除注射部位反应外未发现新的安全问题。此外，皮下注射VDZ具有暴露-反应关系且免疫原性低，经济实惠，患者满意度高。鉴于这些优势，转换治疗可能是可取的。未来，需要更多研究来阐明皮下注射VDZ在IBD治疗中的确切作用，包括优化和转换策略以及基于基线特征的个体化治疗。
