Item request has been placed! ×
Item request cannot be made. ×
loading  Processing Request

Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
  • معلومة اضافية
    • Publication Information:
      Dove Medical Press, 2018.
    • Publication Date:
      2018
    • Collection:
      DOAJ-Articles_enriched
      DOAJ-Articles
    • Abstract:
      Gary T Ferguson,1 Adel H Mansur,2 Joshua S Jacobs,3 Jacques Hebert,4 Corbin Clawson,5 Wenli Tao,6 Yanping Wu,6 Mitchell Goldman6 On behalf of the GREGALE study investigators 1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 2Department of Respiratory Medicine, Birmingham Heartlands Hospital, University of Birmingham, Birmingham, UK; 3Allergy & Asthma Clinical Research, Walnut Creek, CA, USA; 4Clinique Spécialisée en Allergie de la Capitale, Allergie et Immunologie, CHU de Québec, Québec, QC, Canada; 5MedImmune LLC, Gaithersburg, MD, USA; 6AstraZeneca, Gaithersburg, MD, USA Background: Patients prefer at-home subcutaneous administration of biologics across different diseases, yet no biologic is approved for at-home use for severe, uncontrolled asthma. Objective: We assessed at-home functionality, reliability, and performance of an accessorized pre-filled syringe (APFS) for subcutaneous benralizumab administration, an anti-eosinophil monoclonal antibody indicated for add-on maintenance treatment of patients with severe eosinophilic asthma. Materials and methods: Patients (N=116) with severe, uncontrolled asthma despite receiving medium- or high-dosage inhaled corticosteroids and long-acting β2-agonists received up to 5 APFS-administered subcutaneous doses (Weeks 0, 4, 8, 12, and 16) of benralizumab 30 mg. The first 3 doses were administered at the study sites. The patient/caregiver administered the last 2 doses at home. Endpoints included the percentage of dispensed APFS that were used successfully blood eosinophil counts, Asthma Control Questionnaire 6, and safety. Results: Nearly all dispensed APFS were successfully used in the clinic and at home (Week 0: 116/116, 100%; Week 4: 116/117, 99%; Week 8: 115/115, 100%; Week 12: 112/114, 98%; Week 16: 108/109, 99%). Only 1 APFS malfunctioned out of 573 dispensed. Two at-home administrations were unsuccessful because of patient-use error. One unreturned APFS was recorded as nonfunctional. Mean Asthma Control Questionnaire 6 scores decreased from baseline through all post-baseline time points, and nearly complete depletion of eosinophils was observed at the end of treatment. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and sinusitis. Five patients (4%) experienced transient mild or moderate injection-site reactions. Conclusion: The APFS was functional, reliable, and performed equally well in the clinic and at home. Keywords: biologic, subcutaneous, eosinophil, asthma, treatment, patient preference
    • Accession Number:
      pmc: PMC5896651
      pmid: 29670379
    • File Description:
      text/html
    • ISSN:
      1178-6965
    • Accession Number:
      10.2147/JAA.S157762
    • Accession Number:
      edsair.dedup.wf.001..a548cc3a9b5cb2b7364f059168f79023
  • Citations
    • ABNT:
      FERGUSON GT et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Journal of Asthma and Allergy, [s. l.], v. 11, 2018. DOI 10.2147/JAA.S157762. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edsair&AN=edsair.dedup.wf.001..a548cc3a9b5cb2b7364f059168f79023&custid=s8280428. Acesso em: 4 jul. 2020.
    • AMA:
      Ferguson GT, Mansur AH, Jacobs JS, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Journal of Asthma and Allergy. 2018;11. doi:10.2147/JAA.S157762.
    • AMA11:
      Ferguson GT, Mansur AH, Jacobs JS, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Journal of Asthma and Allergy. 2018;11. doi:10.2147/JAA.S157762
    • APA:
      Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, & Goldman M. (2018). Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Journal of Asthma and Allergy, 11. https://doi.org/10.2147/JAA.S157762
    • Chicago/Turabian: Author-Date:
      Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, and Goldman M. 2018. “Assessment of an Accessorized Pre-Filled Syringe for Home-Administered Benralizumab in Severe Asthma.” Journal of Asthma and Allergy 11 (April). doi:10.2147/JAA.S157762.
    • Harvard:
      Ferguson GT et al. (2018) ‘Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma’, Journal of Asthma and Allergy, 11. doi: 10.2147/JAA.S157762.
    • Harvard: Australian:
      Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y & Goldman M 2018, ‘Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma’, Journal of Asthma and Allergy, vol. 11, viewed 4 July 2020, .
    • MLA:
      Ferguson GT, et al. “Assessment of an Accessorized Pre-Filled Syringe for Home-Administered Benralizumab in Severe Asthma.” Journal of Asthma and Allergy, vol. 11, Apr. 2018. EBSCOhost, doi:10.2147/JAA.S157762.
    • Chicago/Turabian: Humanities:
      Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, Wu Y, and Goldman M. “Assessment of an Accessorized Pre-Filled Syringe for Home-Administered Benralizumab in Severe Asthma.” Journal of Asthma and Allergy 11 (April 1, 2018). doi:10.2147/JAA.S157762.
    • Vancouver/ICMJE:
      Ferguson GT, Mansur AH, Jacobs JS, Hebert J, Clawson C, Tao W, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Journal of Asthma and Allergy [Internet]. 2018 Apr 1 [cited 2020 Jul 4];11. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edsair&AN=edsair.dedup.wf.001..a548cc3a9b5cb2b7364f059168f79023&custid=s8280428