Display options
Cite
Pachon JA, Kivitz AJ, Heuer KU, et al. Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis. SAGE Open Med. 2014;2:2050312114564241doi: 10.1177/2050312114564241.
Pachon, J. A., Kivitz, A. J., Heuer, K. U., & Pichlmeier, U. (2014). 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, 22050312114564241. https://doi.org/10.1177/2050312114564241
Pachon, Jaime A, et al. "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 vol. 2 (2014): 2050312114564241. doi: https://doi.org/10.1177/2050312114564241
Pachon JA, Kivitz AJ, Heuer KU, Pichlmeier U. Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis. SAGE Open Med. 2014 Dec 22;2:2050312114564241. doi: 10.1177/2050312114564241. eCollection 2014. PMID: 26770759; PMCID: PMC4712753.
Copy Download .nbib Format: NLM
Share it on

SAGE Open Med. 2014 Dec 22;2:2050312114564241. doi: 10.1177/2050312114564241. eCollection 2014.

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 Pachon, Alan J Kivitz, Kay-Uwe Heuer, Uwe Pichlmeier

Affiliations

  1. Arthritis and RheumaticCareCenter, Miami Research Associates, South Miami, FL, USA.
  2. Altoona Center for Clinical Research, Duncansville, PA, USA.
  3. medac GmbH, Wedel, Germany.

PMID: 26770759 PMCID: PMC4712753 DOI: 10.1177/2050312114564241

Abstract

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 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 of the pen were favorable; 98.1% of patients passed the written examination. All methotrexate pens effectively delivered 0.3 mL methotrexate and were intact after use. Body weight >100 kg significantly decreased total and peak methotrexate exposure when administered abdominally. No adverse effects resulted in drug discontinuation.

CONCLUSION: The methotrexate pen was used with a high degree of effectiveness, satisfaction, and safety, indicating that this delivery system may be a viable option for patients requiring subcutaneous methotrexate.

Keywords: Methotrexate; delivery system; effectiveness; injection; pharmacokinetics; questionnaire; rheumatoid arthritis

References

  1. Rheumatology (Oxford). 2008 Sep;47(9):1438; author reply 1438 - PubMed
  2. Ann Rheum Dis. 2010 Oct;69(10):1849-52 - PubMed
  3. J Pharm Sci. 1989 Feb;78(2):165-71 - PubMed
  4. Diabetes Care. 2004 Oct;27(10):2495-7 - PubMed
  5. Methods Mol Biol. 2010;603:359-63 - PubMed
  6. Patient Prefer Adherence. 2010 Oct 05;4:379-88 - PubMed
  7. Joint Bone Spine. 2006 Jul;73(4):388-95 - PubMed
  8. Expert Opin Drug Deliv. 2009 Sep;6(9):995-1002 - PubMed
  9. Clin Ther. 2006 Oct;28(10):1619-29 - PubMed
  10. Mymensingh Med J. 2013 Jul;22(3):483-8 - PubMed
  11. Br J Rheumatol. 1997 Jan;36(1):86-90 - PubMed
  12. Diabetes Res Clin Pract. 1990 Nov-Dec;10(3):221-30 - PubMed
  13. Acta Paediatr. 1995 Mar;84(3):331-4 - PubMed
  14. Arthritis Rheum. 1992 Jun;35(6):611-4 - PubMed
  15. Clin Neuropharmacol. 2008 May-Jun;31(3):167-72 - PubMed
  16. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Feb 15;885-886:131-7 - PubMed
  17. Clin Endocrinol (Oxf). 2011 Dec;75(6):786-90 - PubMed
  18. J Rheumatol. 2004 Apr;31(4):645-8 - PubMed
  19. Headache. 1998 Apr;38(4):267-9 - PubMed
  20. J Rheumatol. 2011 Dec;38(12):2540-7 - PubMed
  21. Arthritis Rheum. 2008 Jan;58(1):73-81 - PubMed
  22. Clin Chem. 2012 May;58(5):943-5 - PubMed
  23. Clin Ther. 2012 Sep;34(9):1948-53 - PubMed
  24. Ann Rheum Dis. 1994 Jul;53(7):475-7 - PubMed
  25. J Rheumatol. 1993 Nov;20(11):1845-9 - PubMed
  26. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):563-71 - PubMed
  27. J Rheumatol. 2005 Jul;32(7):1412; author reply 1412-3 - PubMed
  28. Pharmacol Rep. 2006 Jul-Aug;58(4):473-92 - PubMed
  29. Mult Scler. 2005 Oct;11(5):585-91 - PubMed
  30. Ann Rheum Dis. 2001 Apr;60(4):432 - PubMed
  31. Rheumatology (Oxford). 2008 Feb;47(2):222 - PubMed
  32. Aliment Pharmacol Ther. 2003 Jul 1;18(1):57-63 - PubMed
  33. J Clin Oncol. 1988 Dec;6(12):1882-6 - PubMed

Publication Types