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通过体内给药系统对多发性骨髓瘤患者皮下注射isatuximab:护士调查结果

Subcutaneous administration of isatuximab in patients with multiple myeloma by an on-body delivery system: results of a nurse survey.

作者信息

Sánchez Avello Nuria, Calvo Pajares Paula, Cordero Paul, Suzan Florence, Barlas Connie

机构信息

Hospital Universitario Marqués de Valdecilla (IDIVAL), Santander, Spain.

Sanofi Research & Development, Reading, United Kingdom.

出版信息

Front Oncol. 2025 Jun 18;15:1547108. doi: 10.3389/fonc.2025.1547108. eCollection 2025.


DOI:10.3389/fonc.2025.1547108
PMID:40606985
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12213733/
Abstract

INTRODUCTION: Subcutaneous (SC) administration of the anti-CD38 antibody isatuximab (Isa) by an on-body delivery system (OBDS), plus pomalidomide-dexamethasone, has demonstrated safety and efficacy comparable to intravenous (IV) administration, with no infusion reactions and excellent local tolerability in multiple myeloma (MM) patients. We report here results of a nurse survey designed to evaluate convenience of treatment with SC Isa, via OBDS, for healthcare providers and MM patients. METHODS: A newly developed, expert-vetted questionnaire was used to survey nurses with experience in SC administration to MM patients enrolled in clinical trials. Results on extent of agreement with pre-vetted statements were expressed as percentages of respondents. Free-text answers were analyzed for each respondent and grouped by topic. RESULTS: All surveyed nurses (N=12) agreed that OBDS administration improved efficiency and was easy to learn and administer with a low level of physical burden, leading to a preference for OBDS over IV Isa administration and facilitating a positive treatment experience for the patients. Compared with IV dosing, the OBDS improved patient comfort and could reduce time spent in the clinic. As agreed by most nurses, main advantages for patients included no needle visibility, short treatment duration, and a generally well-tolerated and painless SC injection. CONCLUSIONS: Our findings show a high level of confidence among nurses in SC Isa administration via OBDS, due to the ease of use, tolerability, and time savings achieved with hands-free OBDS injections. Our findings suggest applicability of the OBDS for convenient SC Isa administration to MM patients in routine clinical practice.

摘要

引言:通过体内给药系统(OBDS)皮下注射抗CD38抗体isatuximab(Isa),联合泊马度胺-地塞米松,已证明其安全性和有效性与静脉注射相当,在多发性骨髓瘤(MM)患者中无输注反应且局部耐受性良好。我们在此报告一项护士调查的结果,该调查旨在评估通过OBDS皮下注射Isa对医护人员和MM患者的治疗便利性。 方法:使用新开发的、经专家审核的问卷对参与临床试验的、有皮下注射MM患者经验的护士进行调查。对预先审核声明的同意程度结果以受访者的百分比表示。对每位受访者的自由文本答案进行分析,并按主题分组。 结果:所有接受调查的护士(N = 12)都认为OBDS给药提高了效率,易于学习和操作,身体负担小,导致他们更倾向于OBDS而非静脉注射Isa给药,并为患者带来积极的治疗体验。与静脉给药相比,OBDS提高了患者的舒适度,并可减少在诊所的时间。大多数护士一致认为,对患者的主要优点包括看不到针头、治疗时间短以及皮下注射总体耐受性良好且无痛。 结论:我们的研究结果表明,护士对通过OBDS皮下注射Isa高度信任,这是因为免手持OBDS注射操作简便、耐受性好且节省时间。我们的研究结果表明,OBDS适用于在常规临床实践中对MM患者进行方便的皮下Isa给药。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/e2feefa4c423/fonc-15-1547108-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/edb2a8519789/fonc-15-1547108-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/3fa305139c44/fonc-15-1547108-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/e2feefa4c423/fonc-15-1547108-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/edb2a8519789/fonc-15-1547108-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/3fa305139c44/fonc-15-1547108-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8ff7/12213733/e2feefa4c423/fonc-15-1547108-g003.jpg

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引用本文的文献

[1]
Letter to the Editor regarding 'Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study'.

Drug Deliv. 2025-12

本文引用的文献

[1]
Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study.

Drug Deliv. 2025-12

[2]
A multicenter, phase Ib study of subcutaneous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

Haematologica. 2024-12-1

[3]
Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management.

Am J Hematol. 2024-9

[4]
Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.

N Engl J Med. 2024-10-31

[5]
Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial.

Nat Med. 2024-8

[6]
Recent Developments in Convenience of Administration of the Anti-CD38 Antibody Isatuximab: Subcutaneous Delivery and Fast Intravenous Infusion in Patients With Multiple Myeloma.

Clin Lymphoma Myeloma Leuk. 2024-6

[7]
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access.

BioDrugs. 2024-1

[8]
Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma.

J Clin Oncol. 2024-1-1

[9]
Evaluation of the economic benefits, administration times, and patient preferences associated with the use of biotechnological drugs administered subcutaneously and intravenously in patients with cancer: a systematic review.

Expert Rev Pharmacoecon Outcomes Res. 2023

[10]
Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study.

Blood Cancer J. 2023-5-9

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