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 A PachonUwe Pichlmeier

Abstract

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. 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. At Visit 1, 12 of 106 patients had questions about the pen, and 4 required self-injection assistance. At Visit 2, the mean performance rating for all scenarios was ≥9.8 (scale: 1 (very difficult)-10 (very easy)). Successful completion rates were 96.2%-100%; 91.3%-100% of patients required no assistance. Impressions ...Continue Reading

References

Nov 1, 1990·Diabetes Research and Clinical Practice·J O HörnquistA M Dufva
Feb 1, 1989·Journal of Pharmaceutical Sciences·R A HermanD E Furst
Dec 1, 1988·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·F M BalisD G Poplack
Apr 4, 2001·Annals of the Rheumatic Diseases·A Osman, D Mulherin
Jul 10, 2003·Alimentary Pharmacology & Therapeutics·D KurnikY Chowers
Apr 22, 2006·Joint, Bone, Spine : Revue Du Rhumatisme·Stephan PavyMaxime Dougados
Jan 24, 2012·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Isabelle LaverdièreChantal Guillemette

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BETA
pharmacotherapies

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NCT01871961

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