Single-center, single-dose, open-label, randomized, two-period crossover study on the bioavailability of methotrexate administered using a novel prefilled, needle-free delivery system

References

• Chabner BA, Allegra CJ, Curt GA, et al. Polyglutamation of methotrexate. Is methotrexate a prodrug? J Clin Invest 1985;76:907-12
   PubMed Web of Science ®Google Scholar
• Dervieux T, Zablocki R, Kremer J. Red blood cell methotrexate polyglutamates emerge as a function of dosage intensity and route of administration during pulse methotrexate therapy in rheumatoid arthritis. Rheumatology (Oxford) 2010;49:2337-45
   PubMed Web of Science ®Google Scholar
• Dalrymple JM, Stamp LK, O’Donnell JL, et al. Pharmacokinetics of oral methotrexate in patients with rheumatoid arthritis. Arthritis Rheum 2008;58:3299-308
   PubMed Web of Science ®Google Scholar
• Methotrexate injection [FDA PI]. Teva Parenteral Medicines Inc., 2016. Available at: http://www.drugs.com/pro/methotrexate-injection.html [Last accessed July 2016]
   Google Scholar
• Chiaravalloti AJ, Strober BE. The use of self-administered subcutaneous methotrexate for the treatment of psoriasis. J Drugs Dermatol 2014;13:929-31
   PubMed Web of Science ®Google Scholar
• Mira JJ, Lorenzo S, Guilabert M, et al. A systematic review of patient medication error on self-administering medication at home. Expert Opin Drug Saf 2015;14:815-38
   PubMed Web of Science ®Google Scholar
• Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol 2007;1:725-9
   PubMedGoogle Scholar
• Logomasini MA, Stout RR, Marcinkoski R. Jet injection devices for the needle-free administration of compounds, vaccines, and other agents. Int J Pharm Compd 2013;17:270-80
   PubMedGoogle Scholar
• Gold K. Analysis: the impact of needle, syringe, and lancet disposal on the community. J Diabetes Sci Technol 2011;5:848-50
   PubMedGoogle Scholar
• Medical devices: guidance document (classification of medical devices). European Commission, 2010. Available at: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf [Last accessed July 2016]
   Google Scholar
• Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol 2016;68:1-26
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492-509
   PubMed Web of Science ®Google Scholar
• Yazici Y, Bata Y. Parenteral methotrexate for the treatment of rheumatoid arthritis. Bull Hosp Jt Dis 2013;71(Suppl 1):46-8
   Google Scholar
• Braun J. Optimal administration and dosage of methotrexate. Clin Exp Rheumatol 2010;28:S46-S51
   PubMed Web of Science ®Google Scholar
• Braun J, Kastner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum 2008;58:73-81
   PubMed Web of Science ®Google Scholar
• Goodman SM, Cronstein BN, Bykerk VP. Outcomes related to methotrexate dose and route of administration in patients with rheumatoid arthritis: a systematic literature review. Clin Exp Rheumatol 2015;33:272-8
   PubMed Web of Science ®Google Scholar
• Pichlmeier U, Heuer KU. Subcutaneous administration of methotrexate with a prefilled autoinjector pen results in a higher relative bioavailability compared with oral administration of methotrexate. Clin Exp Rheumatol 2014;32:563-71
   PubMed Web of Science ®Google Scholar
• Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses >/=15 mg may be overcome with subcutaneous administration. Ann Rheum Dis 2014;73:1549-51
   PubMed Web of Science ®Google Scholar
• Hazlewood GS, Thorne JC, Pope JE, et al. The comparative effectiveness of oral versus subcutaneous methotrexate for the treatment of early rheumatoid arthritis. Ann Rheum Dis 2015
   PubMed Web of Science ®Google Scholar
• Islam MS, Haq SA, Islam MN, et al. Comparative efficacy of subcutaneous versus oral methotrexate in active rheumatoid arthritis. Mymensingh Med J 2013;22:483-8
   PubMedGoogle Scholar
• Guideline on the investigation of bioequivalence. European Medicines Agency, 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf [Last accessed July 2016]
   Google Scholar
• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain 2003;4:407-14
   PubMed Web of Science ®Google Scholar
• Hiraga Y, Yuhki Y, Itoh K, et al. Pharmacokinetics and efficacy of low-dose methotrexate in patients with rheumatoid arthritis. Mod Rheumatol 2004;14:135-42
   PubMedGoogle Scholar
• Lafforgue P, Monjanel-Mouterde S, Durand A, et al. Lack of correlation between pharmacokinetics and efficacy of low dose methotrexate in patients with rheumatoid arthritis. J Rheumatol 1995;22:844-9
   PubMed Web of Science ®Google Scholar
• Comandone A, Passera R, Boglione A, et al. High dose methotrexate in adult patients with osteosarcoma: clinical and pharmacokinetic results. Acta Oncol 2005;44:406-11
   PubMed Web of Science ®Google Scholar
• Danila MI, Hughes LB, Brown EE, et al. Measurement of erythrocyte methotrexate polyglutamate levels: ready for clinical use in rheumatoid arthritis? Curr Rheumatol Rep 2010;12:342-7
   PubMedGoogle Scholar
• Goodman S. Measuring methotrexate polyglutamates. Clin Exp Rheumatol 2010;28:S24-S6
   PubMed Web of Science ®Google Scholar
• Hornung N, Ellingsen T, Attermann J, et al. Patients with rheumatoid arthritis treated with methotrexate (MTX): concentrations of steady-state erythrocyte MTX correlate to plasma concentrations and clinical efficacy. J Rheumatol 2008;35:1709-15
   PubMed Web of Science ®Google Scholar
• Reich K, Langley RG, Papp KA, et al. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med 2011;365:1586-96
   PubMed Web of Science ®Google Scholar
• Visser K, van der Heijde D. Optimal dosage and route of administration of methotrexate in rheumatoid arthritis: a systematic review of the literature. Ann Rheum Dis 2009;68:1094-9
   PubMed Web of Science ®Google Scholar