Pan Fei Yang, Chaemsupaphan Thanaboon, Cartwright Sacha, Leong Rupert
Macquarie University Hospital Macquarie University Australia.
Concord Repatriation General Hospital Australia.
JGH Open. 2025 Jul 28;9(8):e70230. doi: 10.1002/jgh3.70230. eCollection 2025 Aug.
CT-P17 (Yuflyma), a biosimilar to adalimumab (Humira), offers a cost-effective alternative with improved access for individuals with immune-mediated inflammatory diseases (IMIDs). Assessing patient experience with autoinjector usability and comfort is crucial for ensuring adherence and satisfaction. This study is the first to evaluate patient-reported satisfaction and safety of CT-P17 specifically in people with Crohn's disease (CD).
To evaluate patient satisfaction and safety of CT-P17 in CD.
This cross-sectional study included 15 adults (median age 39.9 years) with CD from two Australian hospitals. All participants had prior experience with biologic therapy and used an autoinjector. Patients had either transitioned from adalimumab to CT-P17 or had been receiving CT-P17 for at least 4 weeks. Data collected included baseline demographics, the Harvey Bradshaw Index (HBI), and the Self-Injection Assessment Questionnaire (SIAQ), a validated instrument assessing patient experience, confidence, and satisfaction with self-injection. SIAQ domain scores ranged from 0 (worst) to 10 (best), with higher scores indicating more positive self-injection experiences.
SIAQ scores indicated positive patient experiences. Mean (SD) scores showed high comfort (8.33 ± 1.67), strong self-confidence (8.38 ± 1.53), positive self-image (9.00 ± 2.64), minimal pain/skin reactions (9.22 ± 0.93), and ease of use (8.80 ± 1.89). Overall satisfaction was high (8.76 ± 1.38). HBI scores remained low (mean 0.7), indicating stable disease control.
CT-P17 is well-tolerated in CD patients, with high satisfaction and minimal injection discomfort. Its ergonomic autoinjector design supports ease of use. While larger studies are needed, these findings support the broader adoption of adalimumab biosimilars to enhance patient autonomy and reduce healthcare costs.
CT-P17（Yuflyma）是阿达木单抗（修美乐）的生物类似药，为免疫介导的炎症性疾病（IMIDs）患者提供了一种经济高效的选择，且提高了药物可及性。评估患者对自动注射器易用性和舒适度的体验对于确保依从性和满意度至关重要。本研究是首个专门评估CT-P17在克罗恩病（CD）患者中患者报告的满意度和安全性的研究。
评估CT-P17在CD患者中的满意度和安全性。
这项横断面研究纳入了来自两家澳大利亚医院的15名成年CD患者（中位年龄39.9岁）。所有参与者都有生物治疗经验且使用过自动注射器。患者要么已从阿达木单抗转换为CT-P17，要么已接受CT-P17治疗至少4周。收集的数据包括基线人口统计学信息、哈维·布拉德肖指数（HBI）以及自我注射评估问卷（SIAQ），这是一种经过验证的评估患者自我注射体验、信心和满意度的工具。SIAQ领域得分范围为0（最差）至10（最佳），得分越高表明自我注射体验越积极。
SIAQ得分表明患者体验良好。平均（标准差）得分显示出高舒适度（8.33±1.67）、强烈的自信心（8.38±1.53）、积极的自我形象（9.00±2.64）、最小的疼痛/皮肤反应（9.22±0.93）以及易用性（8.80±1.89）。总体满意度较高（8.76±1.38）。HBI得分仍然较低（平均0.7）表明疾病控制稳定。
CT-P17在CD患者中耐受性良好，满意度高且注射不适最小。其符合人体工程学的自动注射器设计支持易用性。虽然需要更大规模的研究，但这些发现支持更广泛地采用阿达木单抗生物类似药以增强患者自主性并降低医疗成本。
