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患者对用于系统性红斑狼疮患者皮下注射贝利尤单抗的自动注射器的满意度和结局的评价。

Patient Evaluation of Satisfaction and Outcomes with an Autoinjector for Self-Administration of Subcutaneous Belimumab in Patients with Systemic Lupus Erythematosus.

机构信息

Evidera, Bethesda, MD, USA.

, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

出版信息

Patient. 2018 Feb;11(1):119-129. doi: 10.1007/s40271-017-0276-2.

DOI:10.1007/s40271-017-0276-2
PMID:28956281
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5766732/
Abstract

OBJECTIVE

This study assessed patient experiences of using an autoinjector device to self-administer subcutaneous belimumab for the treatment of systemic lupus erythematosus (SLE). Satisfaction, ease and convenience of use, and confidence with the device were assessed, in addition to overall experience with belimumab.

METHODS

This cross-sectional study was conducted among patients who completed a phase IIb open-label, multi-dose usability, tolerability, and safety study of subcutaneous belimumab (NCT02124798), in which patients receiving intravenous belimumab or subcutaneous belimumab using a prefilled syringe were switched to eight weekly self-administered doses of subcutaneous belimumab using the autoinjector. This follow-up study comprised an online/paper questionnaire and qualitative telephone interviews.

RESULTS

In total, 43 patients receiving belimumab completed the questionnaire, 21 of whom also completed a follow-up telephone interview. Qualitative interviews indicated that 17 of 21 (81%) patients had a positive experience using the autoinjector; all patients considered the autoinjector to be convenient. Of the 42 patients who switched from intravenous belimumab to the autoinjector, 32 (76%) expressed a preference for the autoinjector over intravenous administration; reasons included convenience, time saved, cost, and reduced injection pain. The most commonly reported disadvantage of the autoinjector was injection discomfort (n = 5 [24%]; qualitative interview). Compared with intravenous administration, the autoinjector improved ability to work (17 of 29 [59%] of those employed) and carry out daily activities (40%).

CONCLUSION

Patients with SLE reported high levels of satisfaction with the belimumab autoinjector and preferred the autoinjector to intravenous administration, citing advantages such as time saved, cost, and improved ability to work and carry out daily activities.

摘要

目的

本研究评估了患者使用自动注射器装置皮下注射贝利尤单抗治疗系统性红斑狼疮(SLE)的体验。评估了患者对药物的满意度、使用的便利性和信心,以及对贝利尤单抗的整体体验。

方法

这是一项在接受过静脉注射贝利尤单抗或预充式注射器皮下注射贝利尤单抗的患者中开展的、评估皮下注射贝利尤单抗的 IIb 期开放性、多剂量可用性、耐受性和安全性的研究(NCT02124798),这些患者被转换为使用自动注射器接受每周 8 次的皮下注射贝利尤单抗。这项随访研究包括在线/纸质问卷和定性电话访谈。

结果

共 43 名接受贝利尤单抗治疗的患者完成了问卷,其中 21 名患者还完成了后续的电话访谈。定性访谈表明,21 名患者中有 17 名(81%)对自动注射器的使用体验积极;所有患者都认为自动注射器很方便。在 42 名从静脉注射贝利尤单抗转为自动注射器的患者中,32 名(76%)表示更喜欢自动注射器而非静脉注射;原因包括便利性、节省时间、成本和减少注射疼痛。自动注射器最常被报告的缺点是注射不适(n=5 [24%];定性访谈)。与静脉注射相比,自动注射器提高了患者的工作能力(29 名就业患者中有 17 名[59%])和完成日常活动的能力(40%)。

结论

SLE 患者对贝利尤单抗自动注射器的满意度较高,且更倾向于使用自动注射器而非静脉注射,他们表示自动注射器的优势在于节省时间、成本和提高工作能力及完成日常活动的能力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b976/5766732/834f64173e47/40271_2017_276_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b976/5766732/5defbb455b62/40271_2017_276_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b976/5766732/834f64173e47/40271_2017_276_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b976/5766732/5defbb455b62/40271_2017_276_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b976/5766732/834f64173e47/40271_2017_276_Fig2_HTML.jpg

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