D'Arcy Caroline, Thomas Del, Stoneman Dee, Parkes Laura
West London Neuroscience Centre, Charing Cross Hospital, London, UK.
Patient Prefer Adherence. 2012;6:55-61. doi: 10.2147/PPA.S26250. Epub 2012 Jan 18.
Injectable disease-modifying drugs (DMDs) reduce the number of relapses and delay disability progression in patients with relapsing-remitting multiple sclerosis (RRMS). Regular self-injection can be stressful and impeded by MS symptoms. Auto-injection devices can simplify self-injection, overcome injection-related issues, and increase treatment satisfaction. This study investigated patient responses to an electronic auto-injection device.
Patients with RRMS (n = 63), aged 18-65 years, naïve to subcutaneous (sc) interferon (IFN) β-1a therapy, were recruited to a Phase IV, observational, open-label, multicenter study (NCT01195870). Patients self-injected sc IFN β-1a using the RebiSmart™ (Merck Serono S.A. - Geneva, Switzerland) electronic auto-injector for 12 weeks, including an initial titration period if recommended by the prescribing physician. In week 12, patients completed a questionnaire comprising of a visual analog scale (VAS) to rate how much they liked using the device, a four-point response question on ease of use ('very difficult', 'difficult', 'easy', or 'very easy'), and a list of ten device functions to rank, based upon their experiences.
Six patients (9.5%) discontinued the study: one switched to manual injection; two discontinued all treatment; three changed therapy. In total, 59 out of 63 patients (93.7%) completed the VAS; 54 out of 59 (91.5%; 95% confidence interval: 81.3%-97.2%) 'liked' using the electronic auto-injector (score ≥6), whereas 57 out of 59 (96.6%) rated the device overall as 'easy' or 'very easy' to use. Device features rated as most useful were the hidden needle (mean [standard deviation] score: 3.3 [3.01]; n = 56), confirmation sound (3.9 [2.45]), and multidose cartridge (4.6 [2.32]). The least useful functions were the dose history list (8.0 [2.57]) and dose history calendar (7.5 [2.30]).
These findings suggest that the electronic auto-injector may be suitable for patients who are new to injectable DMD therapy. Devices that simplify the injection process may help to ensure that patients receive the full benefits of treatment.
注射用疾病修饰药物（DMDs）可减少复发缓解型多发性硬化症（RRMS）患者的复发次数，并延缓残疾进展。常规自我注射可能会给患者带来压力，且会受到MS症状的影响。自动注射装置可以简化自我注射过程，克服与注射相关的问题，并提高治疗满意度。本研究调查了患者对一种电子自动注射装置的反应。
招募年龄在18 - 65岁、未接受过皮下（sc）干扰素（IFN）β - 1a治疗的RRMS患者（n = 63），参加一项IV期、观察性、开放标签、多中心研究（NCT01195870）。患者使用RebiSmart™（瑞士日内瓦默克雪兰诺公司）电子自动注射器自我注射sc IFN β - 1a，为期12周，若处方医生建议，包括初始滴定期。在第12周，患者完成一份问卷，其中包括一个视觉模拟量表（VAS），用于评估他们对使用该装置的喜爱程度；一个关于易用性的四点反应问题（“非常困难”“困难”“容易”或“非常容易”）；以及一份包含十个装置功能的列表，让患者根据自己的体验进行排序。
6名患者（9.5%）退出研究：1名改为手动注射；2名停止所有治疗；3名更换治疗方案。63名患者中共有59名（93.7%）完成了VAS评估；59名患者中有54名（91.5%；95%置信区间：81.3% - 97.2%）“喜欢”使用电子自动注射器（得分≥6），而59名患者中有57名（96.6%）认为该装置总体使用“容易”或“非常容易”。被评为最有用的装置功能是隐藏针头（平均[标准差]得分：3.3[3.01]；n = 56）、确认声音（3.9[2.45]）和多剂量药筒（4.6[2.32]）。最没用的功能是剂量历史列表（8.0[2.57]）和剂量历史日历（7.5[2.30]）。
这些发现表明，电子自动注射器可能适用于刚开始接受注射用DMD治疗的患者。简化注射过程的装置可能有助于确保患者充分获得治疗益处。
