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从静脉注射达雷妥尤单抗转换为皮下注射剂型前后的感受、认知及体验描述:欧洲多发性骨髓瘤患者的一项混合方法横断面调查

Description of Feelings, Perception, and Experience Before and After Switching from IV Daratumumab to the SC Form: A Mixed-Method, Cross-Sectional Survey in Multiple Myeloma Patients in Europe.

作者信息

Magarotto Valeria, Thevenon Julien, Morgan Kate, Ten Seldam Silene, Iraqi Wafae, Guillaume Xavier, Leclerc Marjorie, Graziani-Taugeron Claire, Rault Bleuenn, Horchi Dahbia

机构信息

MD, Janssen-Cilag, Cologno Monzese, MI, Italy.

Medical Affairs, Janssen Pharmaceuticals, Issy-les-Moulineaux, France.

出版信息

Patient Prefer Adherence. 2024 Sep 10;18:1857-1871. doi: 10.2147/PPA.S453920. eCollection 2024.

Abstract

PURPOSE

To provide real-world data on patient perceptions and experiences with subcutaneous (SC) versus intravenous (IV) daratumumab.

PATIENTS AND METHODS

This was a cross-sectional, mixed-method (qualitative/quantitative) survey conducted in France, Germany, Spain and the United Kingdom involving multiple myeloma (MM) patients who switched from IV to SC daratumumab in the last 12 months (qualitative phase) or 24 months (quantitative phase [26 months in the UK]) prior to enrollment in the study.

RESULTS

Nine patients (mean age 65 years) participated in the qualitative phase and 113 patients (mean age 65.1 years) in the quantitative phase. Qualitative study results provided insights for the quantitative study and highlighted the benefits of switching from daratumumab IV to daratumumab SC as an improvement and a satisfactory change in patients' treatment journey. Quantitative survey showed that patients were significantly less anxious, stressed and nervous before SC injections than IV infusions (mean score: 1.3, 1.1, 1.4 versus 2.1, 2.0, 2.0 respectively, p<0.001), and significantly more reassured, ready/well-prepared, usual self and relieved (mean score: 3.8, 4.3, 3.7, 3.6 versus 3.0, 3.6, 3.1, 3.0 respectively, p<0.001). Immediately after SC first injection, 96.5% patients were feeling well or very well versus 77.9% immediately after IV first infusion (p<0.001). 97.3% patients were satisfied with their SC treatment versus 89.4% for the IV injection (p<0.001). Patients spent significantly less time in hospital for an SC injection of daratumumab than for an IV infusion, 1.5 hours and 5.0 hours respectively (p<0.001). In the UK, the differences between the two administration forms were less visible, likely because of confounding factors including a longer time passed since the switch from the IV to the SC form and administration of the survey.

CONCLUSION

In line with results from other studies, the SC form of daratumumab had less impact on patients' emotional burden than the IV form.

摘要

目的

提供关于皮下注射(SC)与静脉注射(IV)达雷妥尤单抗患者认知和体验的真实世界数据。

患者与方法

这是一项在法国、德国、西班牙和英国开展的横断面、混合方法(定性/定量)调查,涉及在研究入组前过去12个月(定性阶段)或24个月(定量阶段[英国为26个月])从静脉注射达雷妥尤单抗转换为皮下注射达雷妥尤单抗的多发性骨髓瘤(MM)患者。

结果

9名患者(平均年龄65岁)参与了定性阶段,113名患者(平均年龄65.1岁)参与了定量阶段。定性研究结果为定量研究提供了见解,并突出了从静脉注射达雷妥尤单抗转换为皮下注射达雷妥尤单抗作为患者治疗过程中的一种改善和令人满意的变化的益处。定量调查显示,患者在皮下注射前的焦虑、压力和紧张程度明显低于静脉输注(平均得分:分别为1.3、1.1、1.4对2.1、2.0、2.0,p<0.001),并且安心、准备好/准备充分、恢复正常自我和放松程度明显更高(平均得分:分别为3.8、4.3、3.7、3.6对3.0、3.6、3.1、3.0,p<0.001)。首次皮下注射后立即有96.5%的患者感觉良好或非常好,而首次静脉输注后立即为77.9%(p<0.001)。97.3%的患者对皮下注射治疗感到满意,而静脉注射为89.4%(p<0.001)。皮下注射达雷妥尤单抗的患者在医院花费的时间明显少于静脉输注,分别为1.5小时和5.0小时(p<0.001)。在英国,两种给药形式之间的差异不太明显,可能是由于包括从静脉注射形式转换为皮下注射形式后经过的时间更长以及调查实施等混杂因素。

结论

与其他研究结果一致,达雷妥尤单抗的皮下注射形式对患者情绪负担的影响小于静脉注射形式。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b05c/11401519/99fd93e6d43e/PPA-18-1857-g0001.jpg

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