1 HealthCore Inc., Wilmington, Delaware, USA 2 Biogen Idec, Cambridge, Massachusetts, USA.
Patient. 2009 Jun 1;2(2):105-12. doi: 10.2165/01312067-200902020-00006.
: To assess multiple sclerosis (MS) patients' experience with natalizumab (TYSABRI, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.) in a clinical practice setting.
: MS patients who were enrolled in the TOUCH (TYSABRI Outreach Unified Commitment to Health) prescribing program and who had received their third natalizumab infusion participated in this study. Patient-reported measures included an overall quality-of-life (QOL) assessment, an adapted version of the Multiple Sclerosis Impact Scale-29 (MSIS-29), and pre-/post-disease level and functional status scores. MSIS-29 responses were modified to measure patient-perceived change since initiating natalizumab. Paired t-tests assessed pre-/post- changes in disease level and functional status, where negative change indicated improvement.
: Results from 451 patients in this study indicated that 73% were female and, on average, were diagnosed with MS >11 years previously. Almost all (96%) patients had used one or more MS drugs prior to natalizumab initiation. After receiving natalizumab, 97% of all patients reported an improvement or remained stable in their overall QOL. Despite the short treatment duration, there were significant improvements (mean ± SD change) in disease level (-0.26 ± 0.99, paired t-test = 5.47; p < 0.001) and functional status (-0.33 ± 0.73, paired t-test = 9.40; p < 0.001) scores. More than 80% of patients reported an improvement in one or more MSIS-29 physical items. The physical item on the adapted MSIS-29 with the highest reported improvement (58%) was 'the ability to do physically demanding tasks'. The physical item with the lowest reported improvement (32%) was 'problems using transport'.
: Overall, the experiences of MS patients with natalizumab were positive in a clinical practice setting. Patients reported improvements in overall QOL, ambulation and functional status as early as after three natalizumab infusions. While preliminary, these early results are suggestive of a beneficial effect of natalizumab in patients with MS and warrant further long-term investigation of the impact of this treatment on patient outcomes.
评估多发性硬化症（MS）患者在临床实践中使用那他珠单抗（TYSABRI，Biogen Idec，Inc. 和 Elan Pharmaceuticals，Inc.）的体验。
参与 TOUCH（TYSABRI 拓展统一健康承诺）处方计划并接受第三次那他珠单抗输注的 MS 患者参与了这项研究。患者报告的测量包括整体生活质量（QOL）评估、多发性硬化症影响量表-29（MSIS-29）的改编版，以及疾病前/后水平和功能状态评分。MSIS-29 的回答进行了修改，以衡量自开始使用那他珠单抗以来患者感知到的变化。配对 t 检验评估疾病水平和功能状态的前后变化，其中负变化表示改善。
这项研究中的 451 名患者的结果表明，73%为女性，平均诊断为 MS 超过 11 年。几乎所有（96%）患者在开始使用那他珠单抗之前都使用过一种或多种 MS 药物。接受那他珠单抗治疗后，97%的患者报告他们的整体 QOL 有所改善或保持稳定。尽管治疗时间短，但疾病水平（-0.26±0.99，配对 t 检验=5.47；p<0.001）和功能状态（-0.33±0.73，配对 t 检验=9.40；p<0.001）评分均有显著改善。超过 80%的患者报告他们在一个或多个 MSIS-29 身体项目上有所改善。适应性 MSIS-29 上报告改善最高的项目是“完成需要体力的任务的能力”（58%）。报告改善最低的项目是“使用交通工具的问题”（32%）。
总体而言，MS 患者在临床实践中使用那他珠单抗的体验是积极的。患者报告在接受三次那他珠单抗输注后，整体 QOL、步行和功能状态有所改善。虽然初步，但这些早期结果表明那他珠单抗对 MS 患者具有有益的影响，需要进一步长期研究这种治疗对患者结局的影响。
