4,598
Views
12
CrossRef citations to date
0
Altmetric
Treatment

Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results

, MD, , MD, , MD, , PhD, , PhD, , MD, , PhD & , PhD show all
Pages 93-101 | Received 29 Jul 2019, Accepted 31 Aug 2019, Published online: 20 Sep 2019

References

  • Kolbeck R, Kozhich A, Koike M, Peng L, Andersson CK, Damschroder MM, Reed JL, Woods R, Dall’acqua WW, Stephens GL, et al. MEDI-563, a humanized anti–IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125:1344–53. doi:10.1016/j.jaci.2010.04.004.
  • Benralizumab (FASENRA™) prescribing information; 2017 [accessed 2019 Apr 29]. https://www.azpicentral.com/fasenra/fasenra.pdf#page=1.
  • Benralizumab (FASENRA™) summary of product characteristics; 2018 [accessed 2019 Apr 29]. https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf.
  • Tetteh EK, Morris S, Titcheneker-Hooker N. Discrete-choice modelling of patient preferences for modes of drug administration. Health Econ Rev. 2017;7:26. doi:10.1186/s13561-017-0162-6.
  • Stoner KL, Harder H, Fallowfield LJ, Jenkins VA. Intravenous versus subcutaneous drug administration. Which do patients prefer? A systematic review. Patient. 2015;8:145. doi:10.1007/s40271-014-0075-y.
  • Scalone L, Sarzi-Puttini P, Sinigaglia L, Montecucco C, Giacomelli R, Lapadula G, Olivieri I, Giardino AM, Cortesi PA, Mantovani LG, et al. Patients’, physicians’, nurses’, and pharmacists’ preferences on the characteristics of biologic agents used in the treatment of rheumatic diseases. Patient Prefer Adherence. 2018;12:2153–68. doi:10.2147/PPA.S168458.
  • Huynh TK, Ostergaard A, Egsmose C, Madsen OR. Preferences of patients and health professionals for route and frequency of administration of biologic agents in the treatment of rheumatoid arthritis. Patient Prefer Adherence. 2014;8:93–9. doi:10.2147/PPA.S55156.
  • Demary W, Schwenke H, Rockwitz K, Kastner P, Liebhaber A, Schoo U, Hübner G, Pichlmeier U, Guimbal-Schmolck C, Müller-Ladner U. Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience. Patient Prefer Adherence. 2014;8:1061–71. doi:10.2147/PPA.S64111.
  • Vermeire S, D’heygere F, Nakad A, Franchimont D, Fontaine F, Louis E, Van Hootegem P, Dewit O, Lambrecht G, Strubbe B, et al. Preference for a prefilled syringe or an auto-injection device for delivering golimumab in patients with moderate-to-severe ulcerative colitis: a randomized crossover study. Patient Prefer Adherence. 2018;12:1193–202. doi:10.2147/PPA.S154181.
  • Stauffer VL, Sides R, Lanteri-Minet M, Kielbasa W, Jin Y, Selzler KJ, Tepper SJ. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence. 2018;12:1785–95. doi:10.2147/PPA.S170636.
  • Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, Goldman M. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018;11:63–72. doi:10.2147/JAA.S157762.
  • Barker P, Ferguson GT, Cole J, Aurivillius M, Roussel P, Martin U. Single-use autoinjector functionality and reliability for at-home benralizumab administration: GRECO trial results. J Allergy Clin Immunol. 2019;143:AB69.
  • Yan L, Wang B, Chia YL, Roskos LK. Population pharmacokinetic modeling of benralizumab in adult and adolescent patients with asthma. Clin Pharmacokinet. 2019;58:943–58. doi:10.1007/s40262-019-00738-4.
  • Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21–9. doi:10.1016/j.rmed.2016.01.003.
  • Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkström V, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388:2115–27. doi:10.1016/S0140-6736(16)31324-1.
  • FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, et al. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388:2128–41. doi:10.1016/S0140-6736(16)31322-8.
  • Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448–58. doi:10.1056/NEJMoa1703501.
  • Zeraatkari K, Karimi M, Shahrzad MK, Changiz T. Comparison of heparin subcutaneous injection in thigh, arm, & abdomen. Can J Anesth. 2005;52:A109. doi:10.1007/BF03023147.
  • Wang B, Yan L, Yao Z, Roskos LK. Population pharmacokinetics and pharmacodynamics of benralizumab in healthy volunteers and patients with asthma. CPT Pharmacometrics Syst Pharmacol. 2017;6:249–57. doi:10.1002/psp4.12160.