Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis:

SAGE Open Medicine

Jaime APachon¹ 

关键词: Methotrexate;    rheumatoid arthritis;    injection;    pharmacokinetics;    questionnaire;    effectiveness;    delivery system;   

DOI  :  10.1177/2050312114564241

学科分类：医学（综合）

来源: Sage Journals

【 摘 要 】

Objective:To assess usability, bioavailability, and safety of subcutaneous self-administration of 0.3 mL of methotrexate 50 mg/mL solution via a prefilled autoinjector pen (methotrexate pen) in patients with rheumatoid arthritis.Methods:The study enrolled methotrexate-naïve and methotrexate-experienced patients aged ≥16 years. Visit 1 (Day 1) included methotrexate pen usage training with documentation, patient self-injection, and a patient-training questionnaire completed by the healthcare professional. Visit 2 (Days 8–10) included evaluation of patient self-injection through four scenarios: holding needle in place for 5 s, confirming methotrexate delivery, skin pinch, and pen disposal. At Visit 2, patient opinion and training retention (since Visit 1) were also assessed. Pharmacokinetic parameters were assessed in 25 patients, who were stratified by body weight and randomized to receive injections in the abdomen or the upper thigh.Results:At Visit 1, 12 of 106 patients had questions about the pen, and 4 ...

【 授权许可】

CC BY