Ther Adv Musculoskelet Dis. 2012 Feb;4(1):3-9. doi: 10.1177/1759720X11431004.
BACKGROUND/OBJECTIVES: This postmarketing surveillance study assessed the preference, satisfaction, usability, and tolerability of subcutaneous self-administration of a high-concentration (50 mg/ml) ready-to-use formulation of methotrexate (MTX) in patients with rheumatoid arthritis or psoriatic arthritis.
The study enrolled 403 patients with rheumatoid or psoriatic arthritis. The first injection was administered by the attending physician or nurse, followed by five self-administered injections at weekly intervals. The high-concentration formulation consisted of a prefilled syringe with MTX 50 mg/ml solution and a pre-attached needle. Questionnaires were used to document outcomes.
The overall assessment was 'very good' and 'good' in 87.6% of the patients and in 92.8% of the physicians/study nurses. Availability and use of a pre-attached needle was considered as very advantageous and advantageous by 91.8% of the patients and 88.8% of the physicians/study nurses. A total of 96% of the patients described the feeling of the injection as comfortable or tolerable. Patients reported that self-administration led to a feeling of more independence (89.1%) and an improved quality of life (83.6%). A total of 109 patients reported previous self-administration of low-concentration MTX formulations; 94.5% of them stated that they would prefer the high-concentration MTX formulation in the future. The formulation was generally well tolerated. Physicians' expectations concerning the benefit of switching to MTX self-administration was met in 92.8% of the patients. A total of 96.3% of the patients were considered suitable for subcutaneous self-administration of the MTX formulation.
The 50 mg/ml prefilled syringe appears to be a valuable treatment option for patients with rheumatoid and psoriatic arthritis in need of MTX. This is supported by the strong appreciation of the patients as well as their attending healthcare professionals for its convenience and tolerability. The results confirm the findings and experience from a clinical study performed in Germany in 2009, which showed that 93% of the patients prefer the 50 mg/ml prefilled syringe with a pre-attached needle.
背景/目的：本项上市后监测研究评估了类风湿关节炎或银屑病关节炎患者对皮下使用高浓度（50mg/ml）即用型甲氨蝶呤（MTX）的偏好、满意度、可用性和耐受性。
该研究纳入了 403 例类风湿关节炎或银屑病关节炎患者。首次注射由主治医生或护士进行，之后每周进行 5 次自我注射。高浓度制剂由一支预充有 50mg/ml MTX 溶液的注射器和一个预连接的针头组成。问卷调查用于记录结果。
87.6%的患者和 92.8%的医生/研究护士对整体评估为“非常好”和“好”。91.8%的患者和 88.8%的医生/研究护士认为预连接的针头非常有利且有利。96%的患者表示注射感觉舒适或可耐受。患者报告称，自我给药使他们感到更加独立（89.1%）和生活质量提高（83.6%）。共有 109 例患者报告曾自行使用低浓度 MTX 制剂；其中 94.5%的患者表示他们将来更愿意使用高浓度 MTX 制剂。该制剂通常具有良好的耐受性。92.8%的患者认为医生对转换为 MTX 自我给药的益处的预期得到了满足。96.3%的患者被认为适合皮下自我给予 MTX 制剂。
50mg/ml 的预充式注射器似乎是需要 MTX 的类风湿关节炎和银屑病关节炎患者的一种有价值的治疗选择。这得到了患者及其主治医疗保健专业人员的强烈认可，他们认为该制剂方便且耐受性好。这些结果证实了 2009 年在德国进行的一项临床研究的结果和经验，该研究显示 93%的患者更喜欢带有预连接针头的 50mg/ml 预充式注射器。
