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那他珠单抗与复发缓解型多发性硬化症患者工作能力的早期改善相关:WANT 观察性研究结果。

Natalizumab is associated with early improvement of working ability in relapsing-remitting multiple sclerosis patients: WANT observational study results.

机构信息

Multiple Sclerosis Center, Spedali Civili of Brescia, Montichiari, Brescia, Italy.

Dipartimento di Neuroscienze e Scienze Riproduttive ed Odontostomatologiche, Universita degli Studi di Napoli Federico II, Naples, Italy.

出版信息

Neurol Sci. 2021 Jul;42(7):2837-2845. doi: 10.1007/s10072-020-04838-z. Epub 2020 Nov 17.

Abstract

BACKGROUND

The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed work ability, quality of life, and cognitive processing speed during natalizumab treatment.

METHODS

WANT was a 1-year, prospective, multicenter observational study conducted in Italy. Inclusion criteria included relapsing-remitting multiple sclerosis (MS), natalizumab treatment, full-time worker status, and loss of working hours due to MS as measured by the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS). The primary endpoint was change in WPAI:MS domain scores after 1 year on natalizumab. Secondary endpoints included change in annualized relapse rate (ARR), Multiple Sclerosis Impact Scale (MSIS-29) score, and Symbol Digit Modalities Test (SDMT) score.

RESULTS

At enrollment, the 91 patients had a mean age of 38.3 (standard deviation [SD], 9.0) years and a mean ARR of 1.5 (SD, 0.8). After 1 year, improvements were observed in all WPAI:MS domains, with significant reductions in Absenteeism (-4.2 [SD, 26.0], p = 0.0190) and Work Productivity Loss (-7.2 [SD, 28.6]; p = 0.0456). These changes were accompanied by a low ARR (0.1), and 87.9% of patients were relapse free. Significant improvement was observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6; p = 0.0295] and 6.3 [SD, 15.6; p = 0.0007], respectively) and SDMT score (increase of 2.4 [SD, 7.9; p = 0.0006]). Adverse events were reported in 32 of 104 patients (30.8%).

CONCLUSIONS

The reductions in Absenteeism and Work Productivity Loss and the improved physical and psychological functioning reported after 1 year of natalizumab treatment in real-world settings extend our understanding of natalizumab's effects on patient-centric and health economics outcomes.

摘要

背景

在接受那他珠单抗治疗的多发性硬化症患者的工作能力(WANT)研究中评估了工作能力、生活质量和认知处理速度在那他珠单抗治疗期间的变化。

方法

WANT 是一项为期 1 年的前瞻性、多中心观察性研究,在意大利进行。纳入标准包括复发缓解型多发性硬化症(MS)、那他珠单抗治疗、全职工作和 MS 导致的工作时间损失,这是通过 MS 工作生产力和活动障碍问卷(WPAI:MS)测量的。主要终点是接受那他珠单抗治疗 1 年后 WPAI:MS 各领域评分的变化。次要终点包括年化复发率(ARR)、多发性硬化症影响量表(MSIS-29)评分和符号数字模态测验(SDMT)评分的变化。

结果

在入组时,91 名患者的平均年龄为 38.3(标准差 [SD],9.0)岁,平均 ARR 为 1.5(SD,0.8)。经过 1 年,所有 WPAI:MS 领域均有改善,旷工(-4.2 [SD,26.0],p = 0.0190)和工作效率损失(-7.2 [SD,28.6];p = 0.0456)显著减少。这些变化伴随着低的 ARR(0.1),87.9%的患者无复发。MSIS-29 生理和心理领域的显著改善(分别减少 2.8 [SD,11.6;p = 0.0295]和 6.3 [SD,15.6;p = 0.0007])和 SDMT 评分(增加 2.4 [SD,7.9;p = 0.0006])。在 104 名患者中有 32 名(30.8%)报告了不良反应。

结论

在真实环境中接受那他珠单抗治疗 1 年后,旷工和工作效率损失的减少以及生理和心理功能的改善,扩展了我们对那他珠单抗对以患者为中心和健康经济学结果的影响的认识。

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