Antonio Tursi, Giammarco Mocci, Walter Elisei, Edoardo Savarino, Giovanni Maconi, Franco Scaldaferri, Alfredo Papa
{"title":"在治疗炎症性肠病时,从静脉注射到皮下注射维多珠单抗的转换率低于预期。","authors":"Antonio Tursi, Giammarco Mocci, Walter Elisei, Edoardo Savarino, Giovanni Maconi, Franco Scaldaferri, Alfredo Papa","doi":"10.23736/S2724-5985.24.03712-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>It is known that the subcutaneous (SC) route administration of biologic drugs has several potential benefits for patient and the healthcare system. Since few real-world data are available yet about the rate of transition from intravenous (IV) to SC Vedolizumab (VDZ) in the Italian population, we assessed this rate in a large cohort of inflammatory bowel disease (IBD) patients under remission receiving IV VDZ as standard of care in a real-world setting.</p><p><strong>Methods: </strong>Searching who was asked to switch from IV VDZ To SC VDZ, and assessing the rate of acceptance. The Mayo score in Ulcerative colitis (UC) and the Harvey-Bradshaw Index (HBI) in Crohn's Disease (CD) scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.</p><p><strong>Results: </strong>Overall, 238 patients (145 with UC and 93 with CD) having remission ≥1 year with VDZ were asked to switch to VDZ SC, but only nine patients (four with UC and five with CD, 3.78% of the total population to which the switch was proposed) agreed to switch. No difference were found between patients accepting and patients refusing switching about the reasons of the choice. All patients accepting switch maintained clinical remission during the follow-up, and no adverse events were recorded.</p><p><strong>Conclusions: </strong>Switching to SC route is a safe and effective choice for IBD patients under remission using VDZ. However, this choice is not preferred by the majority of patients on stable remission under IV VDZ.</p>","PeriodicalId":94142,"journal":{"name":"Minerva gastroenterology","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Switching rate from intravenous to subcutaneous vedolizumab in managing inflammatory bowel diseases is lower than expected.\",\"authors\":\"Antonio Tursi, Giammarco Mocci, Walter Elisei, Edoardo Savarino, Giovanni Maconi, Franco Scaldaferri, Alfredo Papa\",\"doi\":\"10.23736/S2724-5985.24.03712-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>It is known that the subcutaneous (SC) route administration of biologic drugs has several potential benefits for patient and the healthcare system. Since few real-world data are available yet about the rate of transition from intravenous (IV) to SC Vedolizumab (VDZ) in the Italian population, we assessed this rate in a large cohort of inflammatory bowel disease (IBD) patients under remission receiving IV VDZ as standard of care in a real-world setting.</p><p><strong>Methods: </strong>Searching who was asked to switch from IV VDZ To SC VDZ, and assessing the rate of acceptance. The Mayo score in Ulcerative colitis (UC) and the Harvey-Bradshaw Index (HBI) in Crohn's Disease (CD) scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.</p><p><strong>Results: </strong>Overall, 238 patients (145 with UC and 93 with CD) having remission ≥1 year with VDZ were asked to switch to VDZ SC, but only nine patients (four with UC and five with CD, 3.78% of the total population to which the switch was proposed) agreed to switch. No difference were found between patients accepting and patients refusing switching about the reasons of the choice. All patients accepting switch maintained clinical remission during the follow-up, and no adverse events were recorded.</p><p><strong>Conclusions: </strong>Switching to SC route is a safe and effective choice for IBD patients under remission using VDZ. 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引用次数: 0
摘要
背景:众所周知,通过皮下注射(SC)途径给药的生物制剂对患者和医疗系统都有潜在的好处。由于有关意大利人群从静脉注射 Vedolizumab(VDZ)转为皮下注射 Vedolizumab(VDZ)的实际数据很少,因此我们在一个大型炎症性肠病(IBD)缓解期患者队列中评估了这一比例:搜索被要求从 IV VDZ 转为 SC VDZ 的患者,并评估接受率。溃疡性结肠炎(UC)的梅奥评分和克罗恩病(CD)的哈维-布拉德肖指数(HBI)对临床活动进行评分。随访期间是否达到和维持临床缓解以及安全性是主要终点:总共有238名患者(145名UC患者和93名CD患者)在使用VDZ一年后病情缓解≥1%,他们被要求改用VDZ SC,但只有9名患者(4名UC患者和5名CD患者,占建议改用患者总数的3.78%)同意改用VDZ SC。接受和拒绝转药的患者在选择原因上没有差异。所有接受换药的患者在随访期间都保持了临床缓解,没有不良反应记录:结论:对于使用VDZ的缓解期IBD患者来说,改用SC途径是一种安全有效的选择。结论:对于使用 VDZ 处于缓解期的 IBD 患者来说,改用 SC 途径是一种安全有效的选择,但大多数使用 IV VDZ 处于稳定缓解期的患者并不倾向于这种选择。
Switching rate from intravenous to subcutaneous vedolizumab in managing inflammatory bowel diseases is lower than expected.
Background: It is known that the subcutaneous (SC) route administration of biologic drugs has several potential benefits for patient and the healthcare system. Since few real-world data are available yet about the rate of transition from intravenous (IV) to SC Vedolizumab (VDZ) in the Italian population, we assessed this rate in a large cohort of inflammatory bowel disease (IBD) patients under remission receiving IV VDZ as standard of care in a real-world setting.
Methods: Searching who was asked to switch from IV VDZ To SC VDZ, and assessing the rate of acceptance. The Mayo score in Ulcerative colitis (UC) and the Harvey-Bradshaw Index (HBI) in Crohn's Disease (CD) scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.
Results: Overall, 238 patients (145 with UC and 93 with CD) having remission ≥1 year with VDZ were asked to switch to VDZ SC, but only nine patients (four with UC and five with CD, 3.78% of the total population to which the switch was proposed) agreed to switch. No difference were found between patients accepting and patients refusing switching about the reasons of the choice. All patients accepting switch maintained clinical remission during the follow-up, and no adverse events were recorded.
Conclusions: Switching to SC route is a safe and effective choice for IBD patients under remission using VDZ. However, this choice is not preferred by the majority of patients on stable remission under IV VDZ.