Hope Neurology, 10810 Parkside Drive, #G15, Knoxville, 37934, TN, USA.
Expert Opin Drug Deliv. 2011 Dec;8(12):1543-53. doi: 10.1517/17425247.2011.628656. Epub 2011 Oct 27.
Patients with multiple sclerosis (MS) often receive long-term injectable therapy, and difficulties associated with self-injection can affect treatment adherence and efficacy.
The objective of this study was to evaluate an investigational, ready-to-use, single-use autoinjector for self-injection of subcutaneous (sc) interferon beta-1a (IFNβ-1a).
In this multicenter, open-label, single-arm study, patients with relapsing MS who were receiving IFNβ-1a sc 44 μg three times weekly for ≥ 12 weeks continued therapy using a single-use autoinjector and completed a user trial questionnaire at baseline and weeks 6 and 12. The primary endpoint was the proportion of patients rating the autoinjector as easy or very easy to use at week 12.
At 12 weeks, 86% of 109 patients included in the intent-to-treat population rated the autoinjector easy or very easy to use (95% confidence interval, 80% - 93%), and the most important perceived benefit was its overall convenience. The majority (74%) of patients reported the device as somewhat or extremely convenient to use, and most (83%) agreed or strongly agreed that the device made injections simple.
The single-use autoinjector was well received and supported by favorable ratings for simplified injections and convenience. The results suggest that the device may improve overall injection experience in patients with relapsing MS.
多发性硬化症（MS）患者通常需要长期接受注射治疗，而自我注射相关的困难可能会影响治疗依从性和疗效。
本研究旨在评估一种用于皮下注射干扰素 β-1a（IFNβ-1a）的新型、即用型、一次性自动注射器。
在这项多中心、开放性、单臂研究中，接受 IFNβ-1a 皮下注射 44μg、每周 3 次治疗≥12 周的复发型 MS 患者继续使用一次性自动注射器，并在基线和第 6、12 周完成用户试用问卷。主要终点为第 12 周时，将自动注射器评为易于使用或非常易于使用的患者比例。
在 109 例意向治疗人群中，有 86%的患者在第 12 周时将自动注射器评为易于使用或非常易于使用（95%置信区间，80%-93%），且最被看重的益处是其总体便利性。大多数（74%）患者认为该设备使用起来有些便利或非常便利，且大多数（83%）患者同意或强烈同意该设备使注射变得简单。
一次性自动注射器的使用效果良好，简化注射和提高便利性得到了良好的评价。结果表明，该设备可能会改善复发型 MS 患者的整体注射体验。
