Self-Injection Satisfaction and Safety of CT-P17 (Yuflyma), a High-Concentration Adalimumab Biosimilar, in Patients With Crohn's Disease: A Cross-Sectional Study

IF 1.5 Q3 GASTROENTEROLOGY & HEPATOLOGY

JGH Open Pub Date : 2025-07-28 DOI:10.1002/jgh3.70230

Fei Yang Pan, Thanaboon Chaemsupaphan, Sacha Cartwright, Rupert Leong

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Abstract

Background

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).

Aims

To evaluate patient satisfaction and safety of CT-P17 in CD.

Methods

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.

Results

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.

Conclusions

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.

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一项横断面研究：高浓度阿达木单抗生物类似药CT-P17 （Yuflyma）在克罗恩病患者中的自注射满意度和安全性

CT-P17 （Yuflyma）是阿达木单抗（Humira）的生物类似药，为免疫介导性炎症性疾病（IMIDs）患者提供了一种具有成本效益的替代方案。评估患者对自动注射器的可用性和舒适性的体验对于确保依从性和满意度至关重要。这项研究首次评估了患者报告的CT-P17在克罗恩病（CD）患者中的满意度和安全性。目的评价CT-P17治疗CD患者的满意度和安全性。方法本横断面研究包括来自澳大利亚两家医院的15名成年CD患者（中位年龄39.9岁）。所有参与者之前都有生物治疗的经验，并使用了自动注射器。患者要么从阿达木单抗过渡到CT-P17，要么已经接受CT-P17治疗至少4周。收集的数据包括基线人口统计数据、Harvey Bradshaw指数（HBI）和自我注射评估问卷（SIAQ），这是一种评估患者体验、信心和自我注射满意度的有效工具。SIAQ域得分从0（最差）到10（最好）不等，得分越高表明自我注射体验越积极。结果SIAQ评分提示患者体验良好。平均（SD）评分显示舒适度高（8.33±1.67），自信心强（8.38±1.53），自我形象积极（9.00±2.64），疼痛/皮肤反应最小（9.22±0.93），使用方便（8.80±1.89）。总体满意度较高（8.76±1.38）。HBI评分仍然很低（平均0.7），表明疾病控制稳定。结论CT-P17在CD患者中耐受性良好，满意度高，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，以增强患者的自主权并降低医疗成本。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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