Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: The TOUCH trial
Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: The TOUCH trial
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DOI：
10.1016/j.clinthera.2006.10.006
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发表时间：
2006-10-01
影响因子：
3.2
通讯作者：
Segurado, Oscar G.
中科院分区：
文献类型：
--
作者：
Kivitz, Alan;Cohen, Steven;Segurado, Oscar G.
背景资料：阿达木单抗是一种治疗性单克隆抗体，通过2种提供生物等效量阿达木单抗的一次性注射装置进行SC给药：即用型预充式注射器和一体式一次性给药系统（自动注射笔）。虽然笔已被证明是需要长期SC给药的患者首选注射器，但没有关于慢性炎症性疾病患者使用生物制剂的偏好和疼痛的数据。目的：本研究的目的是评估阿达木单抗2种给药系统的注射部位疼痛、耐受性和患者偏好。方法：类风湿性关节炎患者入组了一项II期、多中心、开放标签、单臂、序贯试验。患者在3次监测的临床访视（访视1（注射器）、访视2和3（注射笔））中每隔一周自我给予标准剂量阿达木单抗40 mg SC。在每次访视时，患者在注射后即刻和注射后15-30分钟使用11分量表（0 =无至10 =疼痛最严重）对其疼痛进行评分，并提供其对每种输送系统的印象和偏好。结果：52名患者参加了试验，并完成了所有3次访视（32名女性，20名男性;平均[SD]年龄，53.8 [12.1]岁）。40例（76.9%）患者报告注射笔的疼痛小于注射器，4例（7.7%）患者发现注射器的疼痛较小，8例（15.4%）患者无偏好。从访视1至访视2和从访视1至访视3，患者的注射疼痛评分有统计学显著性降低。未观察到新的安全性信号或注射器与注射笔之间耐受性的明显差异。此外，46例（88.5%）患者首选注射笔，3例（5.8%）首选注射器，3例（5.8%）无偏好。总体而言，患者评价笔更容易使用（94.2%），更方便（92.3%），需要更短的注射时间（82.7%），更安全（88.5%）。结论：患者通过笔自我给药阿达木单抗的疼痛更少，与注射器相比更喜欢它。此外，患者认为注射笔更易于使用且更方便。两种给药系统的耐受性通常良好。(Clin Ther. 2006; 28：1619-1629）版权所有（c）2006 Excerpta Medica，Inc.
Background: Adalimumab is a therapeutic Monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases.Objective: The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab.Methods: Patients with rheumatoid arthritis were enrolled in a Phase II, multicenter, open-label, single-arm, sequential trial. Patients self-administered a standard dose of adalimumab 40 mg SC every other week at each of 3 monitored clinical visits: visit 1 (syringe), visits 2 and 3 (Pen). At each visit, patients rated their pain on an 11-point scale (0 = none to 10 = pain as bad as it could be) immediately after injection and 15-30 minutes after injection and provided their impressions of and preferences for each delivery system. Safer), events were recorded throughout the study and 70 days after final study dose.Results: Fifty-two patients were enrolled in the trial and completed all 3 visits (32 women, 20 men; mean [SD] age, 53.8 [12.1] years). Forty (76.9%) patients reported that the Pen was less painful than the syringe, 4 (7.7%) patients found the syringe to be less painful, and 8 (15.4%) patients had no preference. Patients had statistically significant reductions in injection-pain scores from visit 1 to visit 2 and from visit 1 to visit 3. No new safety signals or apparent differences regarding tolerability between the syringe and Pen were observed. In addition, 46 (88.5%) patients preferred the Pen, 3 (5.8%) preferred the syringe, and 3 (5.8%) had no preference. Overall, patients evaluated the Pen as easier to use (94.2%), more convenient (92.3%), requiring less time to inject (82.7%), and safer (88.5%).Conclusions: Patients experienced less pain self-administering adalimumab via the Pen and preferred it versus the syringe. Further, patients perceived the Pen to be easier to use and more convenient. Both delivery systems were generally well tolerated. (Clin Ther. 2006; 28:1619-1629) Copyright (c) 2006 Excerpta Medica, Inc.