Gastroenterology Unit, DiMePreJ, "Aldo Moro" University, Bari, Italy.
P.O. Di Venere, UOSVD Screening Colon Retto Endoscopia Digestiva, Bari, Italy.
Dig Dis Sci. 2024 Dec;69(12):4458-4466. doi: 10.1007/s10620-024-08631-2. Epub 2024 Sep 30.
Transition from intravenous (IV) to subcutaneous (SC) administration is an option in inflammatory bowel disease (IBD) with Infliximab (IFX) or Vedolizumab (VDZ). The aim was to compare the adherence, the persistence in therapy, and quality of life (QoL) at baseline, at 6, at 12 months of SC IFX versus SC VDZ.
This was a prospective, observational, multicenter study on patients with IBD in treatment with IV IFX or VDZ who switched to SC. All patients investigated the QoL by the short IBD Questionnaire (sIBDQ) and the concerns and expectations by a 6-item survey. Any adverse events, local and systemic, were reported. Safety, concerns, and satisfaction were evaluated.
One hundred and eight out of 93 patients were replaced, 51 to SC IFX and 42 to SC VDZ. The majority accepted the SC route. Persistence in therapy was similar between the two groups. The QoL improved after 6 months (p = 0.004), but at T12 both groups show a significant decline in QoL. SC administration has not caused any concern for patients. As safety, both groups reported a similar number of local reactions (IFX 19.60% vs VDZ 19.04%). In the IFX group were reported more systemic reactions (IFX 11.6% vs VDZ 7.14%) without the need for hospitalization.
The transition from IV to SC administration is an appropriate and safe option for treatment with IFX or VDZ. It is very important to consider the patient's choice and preference. The SC administration led to a significant benefit in QoL, especially in the first 6 months of therapy.
在英夫利昔单抗（IFX）或维得利珠单抗（VDZ）治疗炎症性肠病（IBD）中，从静脉（IV）给药转为皮下（SC）给药是一种选择。本研究旨在比较 SC IFX 与 SC VDZ 治疗的 IBD 患者的依从性、治疗持续时间和基线、6 个月和 12 个月时的生活质量（QoL）。
这是一项前瞻性、观察性、多中心研究，纳入正在接受 IV IFX 或 VDZ 治疗的 IBD 患者，这些患者转为 SC 治疗。所有患者均通过简短 IBD 问卷（sIBDQ）和 6 项调查评估 QoL，并报告任何不良反应，包括局部和全身不良反应。评估安全性、关注问题和满意度。
93 例患者中有 108 例接受了替代治疗，其中 51 例转为 SC IFX 治疗，42 例转为 SC VDZ 治疗。大多数患者接受了 SC 治疗方案。两组患者的治疗持续时间相似。治疗 6 个月后 QoL 改善（p=0.004），但两组在 12 个月时 QoL 均显著下降。SC 给药并未引起患者的关注问题。安全性方面，两组报告的局部反应（IFX 组 19.60% vs VDZ 组 19.04%）和全身反应（IFX 组 11.6% vs VDZ 组 7.14%）发生率相似，均无需住院治疗。
从 IV 给药转为 SC 给药是 IFX 或 VDZ 治疗的一种合适且安全的选择。考虑患者的选择和偏好非常重要。SC 给药在 QoL 方面具有显著获益，尤其是在治疗的前 6 个月。
