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用于多发性硬化症的奥法木单抗注射剂和自动注射器装置的真实世界满意度及使用体验

Real-world satisfaction and experience with injection and autoinjector device for ofatumumab indicated for multiple sclerosis.

作者信息

Ross Amy Perrin, Nicholas Jacqueline, Tai Ming-Hui, Yeung Stephen, Shaikh Nazneen Fatima, Chen Helen, Fernandes Mariana, Cortright Aaron, Hawkins Kevin

机构信息

Neuroscience Nurse Consultant, Oak Brook, IL, 60660, USA.

OhioHealth Multiple Sclerosis Center, 3535 Olentangy River Rd, Suite 1501, Columbus, OH, 43214, USA.

出版信息

BMC Neurol. 2025 Jan 20;25(1):28. doi: 10.1186/s12883-024-04007-1.

DOI:10.1186/s12883-024-04007-1
PMID:39833702
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11744959/
Abstract

BACKGROUND

To evaluate the overall satisfaction, device usability, and injection experience of MS patients self-administering ofatumumab using the Sensoready autoinjector device in the United States (US).

METHODS

This US-based, cross-sectional survey study included patients with MS (≥ 18 years) who self-administered ofatumumab using the Sensoready device within the previous 12 months of the survey. Eligible patients were administered a 30-item de novo questionnaire that focused on overall device satisfaction, device usability, convenience/flexibility for travel with the device, user confidence, injection experience, and time to administer the injection. Ratings were measured on Likert and numeric rating scales, with higher scores indicating positive responses.

RESULTS

Overall, 105 patients with MS (disease-modifying therapy [DMT]-experienced: 65; DMT-naïve: 40) were included. The mean (standard deviation [SD]) age was 42.5 (12.2) years. The majority of patients (86.7%) expressed high satisfaction (i.e., rated either 4 [satisfied] or 5 [extremely satisfied] on a 5-point Likert scale) in study population. The overall mean (SD) satisfaction score with Sensoready device was 4.4 (0.7), with a higher device satisfaction reported in the DMT-experienced vs. DMT-naïve group (4.6 [0.66] vs. 4.1 [0.69]). A higher proportion of DMT-experienced patients reported high satisfaction scores as compared to DMT-naïve patients (90.8% vs. 80.0%). The most common reasons for high satisfaction included reasonable administration time (90.5%), overall ease of use (89.5%), a monthly dosing schedule of ofatumumab (89.5%), the time required for device preparation (86.7%), ease of device preparation (81.9%), device ergonomics (76.2%), and portability (73.3%). Regardless of prior DMT experience, the majority of patients felt confident to self-administer ofatumumab using the Sensoready device; moreover, the majority expressed their intention to continue with the Sensoready device and would recommend ofatumumab to others. Furthermore, 77.1% reported that the use of Sensoready device to self-administer ofatumumab was not found to interfere with their daily activities; patients reporting non-interference with their daily activities were higher in the DMT-experienced vs. DMT-naïve group (83.1% vs. 67.5%).

CONCLUSIONS

Regardless of prior DMT experience, patients with MS report high satisfaction levels and positive experiences with the use of the ofatumumab Sensoready device in real-world practice, mostly driven by reasonable administration time and ease-of-use.

摘要

背景

评估美国多发性硬化症(MS)患者使用Sensoready自动注射器自行注射奥法妥木单抗的总体满意度、设备易用性和注射体验。

方法

这项基于美国的横断面调查研究纳入了年龄≥18岁、在调查前12个月内使用Sensoready设备自行注射奥法妥木单抗的MS患者。符合条件的患者接受了一份30项全新问卷的调查,该问卷重点关注设备总体满意度、设备易用性、携带设备旅行的便利性/灵活性、用户信心、注射体验以及注射所需时间。评分采用李克特量表和数字评分量表进行测量,分数越高表明反应越积极。

结果

总体而言,纳入了105例MS患者(有疾病改善治疗[DMT]经验的:65例;初治DMT的:40例)。平均(标准差[SD])年龄为42.5(12.2)岁。大多数患者(86.7%)在研究人群中表示高度满意(即在5分李克特量表上评为4[满意]或5[极其满意])。Sensoready设备的总体平均(SD)满意度评分为4.4(0.7),有DMT经验的组比初治DMT的组报告的设备满意度更高(4.6[0.66]对4.1[0.69])。与初治DMT的患者相比,有DMT经验的患者中报告高满意度评分的比例更高(90.8%对80.0%)。高度满意的最常见原因包括给药时间合理(90.5%)、总体易用性(89.5%)、奥法妥木单抗每月给药方案(89.5%)、设备准备所需时间(86.7%)、设备准备容易(81.9%)、设备人体工程学(76.2%)和便携性(73.3%)。无论之前有无DMT经验,大多数患者对使用Sensoready设备自行注射奥法妥木单抗感到有信心;此外,大多数患者表示打算继续使用Sensoready设备,并会向他人推荐奥法妥木单抗。此外,77.1%的患者报告使用Sensoready设备自行注射奥法妥木单抗未干扰其日常活动;报告日常活动未受干扰的患者在有DMT经验的组比初治DMT的组更高(83.1%对67.5%)。

结论

无论之前有无DMT经验,MS患者在实际应用中对使用奥法妥木单抗Sensoready设备报告了高度满意度和积极体验,这主要是由合理的给药时间和易用性驱动的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/c9fbf066d3e9/12883_2024_4007_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/e54d84d7c397/12883_2024_4007_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/69a3aeed09fb/12883_2024_4007_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/c9fbf066d3e9/12883_2024_4007_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/e54d84d7c397/12883_2024_4007_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/69a3aeed09fb/12883_2024_4007_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a5e2/11744959/c9fbf066d3e9/12883_2024_4007_Fig3_HTML.jpg

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Preferences and Perspectives of Specialist Multiple Sclerosis Nurses and Patients with Multiple Sclerosis Regarding the New RebiSmart 3.0 Autoinjector versus Other Assistive Devices.多发性硬化专科护士和多发性硬化患者对新型RebiSmart 3.0自动注射器与其他辅助设备的偏好和看法。
Med Devices (Auckl). 2024 Feb 19;17:59-71. doi: 10.2147/MDER.S438883. eCollection 2024.
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Assessment of the treating physicians' first-hand experience with handling and satisfaction of ofatumumab therapy: findings from the PERITIA survey conducted in Europe.评估治疗医生在处理奥法妥木单抗治疗方面的第一手经验和满意度:来自欧洲 PERITIA 调查的结果。
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