Novartis Pharma AG, Lichtstrasse 35, CH-4056, Basel, Switzerland.
Ther Deliv. 2023 Apr;14(4):259-268. doi: 10.4155/tde-2023-0022. Epub 2023 Jun 26.
The Sensoready pen is intended for self-administration of subcutaneous 20 mg ofatumumab at home. This human factors summative study assessed the usability of the Sensoready pen in relapsing multiple sclerosis patients. 32 patients (injection-experienced [n = 17] and injection-naive [n = 15]) across five locations in the USA were asked to complete two simulated injections using the Sensoready pen. In the first and second simulated injections, 90.6 and 96.9% of patients, respectively, successfully delivered a full dose, while 81.3 and 84.4%, respectively, successfully performed the injection without any use errors. The Sensoready pen is safe and effective for its intended use by intended users and in the intended use environment. This pen has a low harm potential and high injection success rate in patients, even without prior training or experience.
Sensoready 笔旨在供患者在家中自行皮下注射 20 毫克奥法妥木单抗。这项以人为中心的总结性研究评估了 Sensoready 笔在复发型多发性硬化症患者中的可用性。在美国五个地点的 32 名患者（有注射经验者 [n=17] 和无注射经验者 [n=15]）被要求使用 Sensoready 笔完成两次模拟注射。在第一次和第二次模拟注射中，分别有 90.6%和 96.9%的患者成功注射了全剂量药物，而分别有 81.3%和 84.4%的患者在注射过程中没有出现任何使用错误。Sensoready 笔在预期使用者和预期使用环境中安全且有效，用于其预期用途。即使没有事先接受培训或经验，这种笔在患者中也具有较低的伤害风险和较高的注射成功率。
