Hoffmann Frank A, Trenova Anastasiya, Llaneza Miguel A, Fischer Johannes, Lus Giacomo, von Bredow Dorothea, Lara Núria, Lam Elaine, Van Hoef Marlies, Bakshi Rajesh
Department of Neurology, Hospital Martha-Maria Halle-Dölau, Halle, Germany.
Department of Neurology, Medical University of Plovdiv, Plovdiv, Bulgaria.
BMC Neurol. 2017 Aug 9;17(1):156. doi: 10.1186/s12883-017-0928-9.
Patients with multiple sclerosis (MS) receiving long-term, subcutaneous interferon β-1b (IFN β-1b; Extavia®) often experience injection-site reactions and injection-site pain, which together with other side-effects (such as flu-like symptoms) result in suboptimal treatment compliance/adherence. The EXCHANGE study evaluated patient satisfaction with IFN β-1b treatment, administered using ExtaviPro™ 30G, a new auto-injector, in a real-world setting.
This 26-week, open-label, prospective, non-interventional, observational, multi-country multi-centre study enrolled patients with MS who had been treated with IFN β-1b or other disease-modifying therapies with a self-administered auto-injector for ≥3 months and who were planned to switch to IFN β-1b treatment administered using ExtaviPro™ 30G as part of routine clinical care. Patient-reported outcomes included overall patient satisfaction (primary outcome) and satisfaction associated with treatment effectiveness, convenience and side-effects, assessed using Treatment Satisfaction Questionnaire for Medication (TSQM)-14. The changes in TSQM scores from baseline to Week 26 were reported. All data were analysed using SAS statistical software (version 9.4).
Of the 336 patients enrolled, 324 were included in the analysis. At baseline, mean ± standard deviation (SD) age of patients was 41.8 ± 11.3 years and 68.2% were women. The mean ± SD of MS disease duration was 6.9 ± 6.6 years, and the majority of patients (94.1%) had relapsing-remitting MS. The mean ± SD of TSQM score for overall patient satisfaction at Week 26 was 75.6 ± 16.46 (baseline, 73.0 ± 17.14; p = 0.0342). The mean ± SD of TSQM subscale scores for patient satisfaction with effectiveness, side-effects and convenience were 75.0 ± 18.65 (baseline, 71.6 ± 19.45; p = 0.0356), 88.5 ± 18.98 (baseline, 82.7 ± 22.93; p = 0.0002) and 77.6 ± 16.72 (baseline, 71.1 ± 17.53; p < 0.0001), respectively.
The results from this real-world study suggest that administering IFN β-1b with the new ExtaviPro™ auto-injector significantly improves overall patient satisfaction, including satisfaction associated with effectiveness, side-effects and convenience in MS patients.
接受长期皮下注射干扰素β-1b（IFNβ-1b；复迈®）治疗的多发性硬化症（MS）患者常出现注射部位反应和注射部位疼痛，这些症状与其他副作用（如流感样症状）共同导致治疗依从性欠佳。EXCHANGE研究在现实环境中评估了患者对使用新型自动注射器ExtaviPro™ 30G给予IFNβ-1b治疗的满意度。
这项为期26周的开放标签、前瞻性、非干预性、观察性、多国多中心研究纳入了曾使用自动注射器自我注射IFNβ-1b或其他疾病修饰疗法≥3个月且计划改用ExtaviPro™ 30G给予IFNβ-1b治疗作为常规临床护理一部分的MS患者。患者报告的结局包括总体患者满意度（主要结局）以及与治疗有效性、便利性和副作用相关的满意度，使用药物治疗满意度问卷（TSQM）-14进行评估。报告了从基线到第26周TSQM评分的变化。所有数据均使用SAS统计软件（9.4版）进行分析。
在纳入的336例患者中，324例纳入分析。基线时，患者的平均年龄±标准差（SD）为41.8±11.3岁，68.2%为女性。MS疾病病程的平均±SD为6.9±6.6年，大多数患者（94.1%）为复发缓解型MS。第26周总体患者满意度的TSQM评分平均±SD为75.6±16.46（基线时为73.0±17.14；p = 0.0342）。患者对有效性、副作用和便利性满意度的TSQM子量表评分平均±SD分别为75.0±18.65（基线时为71.6±19.45；p = 0.0356）、88.5±18.98（基线时为82.7±22.93；p = 0.0002）和77.6±16.72（基线时为71.1±17.53；p < 0.0001）。
这项现实研究的结果表明，使用新型ExtaviPro™自动注射器给予IFNβ-1b可显著提高总体患者满意度，包括MS患者对有效性、副作用和便利性的满意度。
