Texas Neurology, 6301 Gaston Ave, West Tower, #100, Dallas, Texas, USA.
BMC Neurol. 2011 Oct 14;11:126. doi: 10.1186/1471-2377-11-126.
The ability to self-inject in patients with multiple sclerosis (MS) has been associated with a reduced risk of missed injections and drug discontinuation, and a beneficial effect on patients' independence. However, injection anxiety, needle phobia and disease-related disability are major barriers to a patient's ability to self-administer treatment. Use of an autoinjector may improve patients' ability to self-inject. This study evaluated the safe and effective use of Avonex Pen™ (prefilled pen), a single use autoinjector, for intramuscular delivery of interferon beta-1a (IM IFNβ-1a, Avonex) in MS patients.
This was a Phase IIIb, open-label, single-country, multicenter trial in MS patients currently using IM IFNβ-1a prefilled syringes. Patients received weekly 30 mcg IM IFNβ-1a treatment over 4 weeks. On Day 1, patients self-administered IM IFNβ-1a using a prefilled syringe at the clinic. On Day 8, patients received training on the prefilled pen and self-administered IM IFNβ-1a using the device. On Day 15, patients self-administered IM IFNβ-1a at home using the prefilled pen. A final injection occurred at the clinic on Day 22 when patients self-administered IM IFNβ-1a using the prefilled pen while clinic staff observed and completed a detailed questionnaire documenting patients' ability to self-inject with the device. Serum neopterin levels were evaluated pre and post-injection on Days 1 and 8. Adverse events were monitored throughout.
Seventy-one (96%) patients completed the study. The overall success rate in safely and effectively using the prefilled pen was 89%. No device malfunctions occurred. One unsuccessful administration occurred at Day 22 due to patient error; no patient injury resulted. Patients gave the prefilled pen high ratings (8.7-9.3) on a 10-point scale for ease of use (0 = extremely difficult, 10 = extremely easy). Ninety-four percent of patients preferred the prefilled pen over the prefilled syringe. Induction of serum neopterin levels, serving as a biomarker for type 1 interferon action, was similar to that of the prefilled syringe. The prefilled pen demonstrated a safety profile comparable to the prefilled syringe.
The prefilled pen is a safe and effective device for administration of IM IFNβ-1a and represents an alternative method for self-injection for MS patients using this therapy.
This study is registered at clinicaltrials.gov, identifier: NCT00828204.
多发性硬化症（MS）患者的自我注射能力与减少漏注和停药风险以及提高患者独立性有关。然而，注射焦虑、恐针和与疾病相关的残疾是患者自我治疗能力的主要障碍。使用自动注射器可以提高患者的自我注射能力。本研究评估了 Avonex Pen™（预充笔），一种单次使用的自动注射器，在 MS 患者中用于肌内递送干扰素β-1a（IM IFNβ-1a，Avonex）的安全性和有效性。
这是一项在当前使用 IM IFNβ-1a 预充注射器的 MS 患者中进行的 IIIb 期、开放标签、单国、多中心试验。患者接受每周 30 mcg IM IFNβ-1a 治疗 4 周。第 1 天，患者在诊所使用预充注射器进行自我 IM IFNβ-1a 注射。第 8 天，患者接受预充笔使用培训，并使用该设备进行自我 IM IFNβ-1a 注射。第 15 天，患者在家中使用预充笔进行自我 IM IFNβ-1a 注射。第 22 天，当患者在诊所使用预充笔进行自我 IM IFNβ-1a 注射时，诊所工作人员观察并完成详细问卷记录患者使用该设备自我注射的能力，最后一次注射发生在诊所。在第 1 天和第 8 天注射前和后评估血清新蝶呤水平。整个过程中监测不良事件。
71 名（96%）患者完成了研究。安全有效地使用预充笔的总体成功率为 89%。未发生设备故障。第 22 天，由于患者错误，一次给药不成功；没有造成患者受伤。患者对预充笔的易用性给予了 8.7-9.3 的高分（0=非常困难，10=非常容易）。94%的患者更喜欢预充笔而不是预充注射器。血清新蝶呤水平的诱导，作为 1 型干扰素作用的生物标志物，与预充注射器相似。预充笔的安全性与预充注射器相当。
预充笔是一种安全有效的 IM IFNβ-1a 给药装置，为使用该疗法的 MS 患者提供了一种自我注射的替代方法。
本研究在 clinicaltrials.gov 注册，标识符：NCT00828204。
