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Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects
Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5063175/ https://www.ncbi.nlm.nih.gov/pubmed/27163500 http://dx.doi.org/10.1002/cpdd.219 |
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author | Struemper, Herbert Murtaugh, Thomas Gilbert, Jane Barton, Matthew E. Fire, Joseph Groark, James Fox, Norma Lynn Roth, David Gordon, David |
author_facet | Struemper, Herbert Murtaugh, Thomas Gilbert, Jane Barton, Matthew E. Fire, Joseph Groark, James Fox, Norma Lynn Roth, David Gordon, David |
author_sort | Struemper, Herbert |
collection | PubMed |
description | Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects using a single‐use autoinjector or prefilled syringe. Subjects (randomized 1:1:1:1) self‐administered belimumab 200 mg subcutaneously (abdomen or thigh) by prefilled syringe or autoinjector. Pharmacokinetics, adverse events (AEs), injection‐site pain, and administration errors were recorded. Of 81 subjects, 5 experienced administration errors and were excluded from pharmacokinetic analyses. Mean serum belimumab concentration profiles were similar for both devices, with a weak trend toward higher concentrations for thigh injection compared with abdominal injections. Maximum observed serum concentration was slightly higher with the autoinjector (27.0 vs 25.3 µg/mL) and area under the concentration–time curve slightly lower (701 vs 735 day · μg/mL), compared with the prefilled syringe. Incidence of AEs was 51% (41 of 81 subjects; headache was most common), with no serious or severe AEs. Median injection‐site pain scores were low (0 after 1 hour). Device handling was reported as acceptable by ≥95% of autoinjector users and ≥90% of prefilled syringe users for each characteristic assessed. These results support the use of either device for belimumab subcutaneous administration. |
format | Online Article Text |
id | pubmed-5063175 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50631752016-10-19 Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects Struemper, Herbert Murtaugh, Thomas Gilbert, Jane Barton, Matthew E. Fire, Joseph Groark, James Fox, Norma Lynn Roth, David Gordon, David Clin Pharmacol Drug Dev Articles Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects using a single‐use autoinjector or prefilled syringe. Subjects (randomized 1:1:1:1) self‐administered belimumab 200 mg subcutaneously (abdomen or thigh) by prefilled syringe or autoinjector. Pharmacokinetics, adverse events (AEs), injection‐site pain, and administration errors were recorded. Of 81 subjects, 5 experienced administration errors and were excluded from pharmacokinetic analyses. Mean serum belimumab concentration profiles were similar for both devices, with a weak trend toward higher concentrations for thigh injection compared with abdominal injections. Maximum observed serum concentration was slightly higher with the autoinjector (27.0 vs 25.3 µg/mL) and area under the concentration–time curve slightly lower (701 vs 735 day · μg/mL), compared with the prefilled syringe. Incidence of AEs was 51% (41 of 81 subjects; headache was most common), with no serious or severe AEs. Median injection‐site pain scores were low (0 after 1 hour). Device handling was reported as acceptable by ≥95% of autoinjector users and ≥90% of prefilled syringe users for each characteristic assessed. These results support the use of either device for belimumab subcutaneous administration. John Wiley and Sons Inc. 2015-12-04 2016 /pmc/articles/PMC5063175/ /pubmed/27163500 http://dx.doi.org/10.1002/cpdd.219 Text en © 2015, The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Struemper, Herbert Murtaugh, Thomas Gilbert, Jane Barton, Matthew E. Fire, Joseph Groark, James Fox, Norma Lynn Roth, David Gordon, David Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title | Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title_full | Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title_fullStr | Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title_full_unstemmed | Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title_short | Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects |
title_sort | relative bioavailability of a single dose of belimumab administered subcutaneously by prefilled syringe or autoinjector in healthy subjects |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5063175/ https://www.ncbi.nlm.nih.gov/pubmed/27163500 http://dx.doi.org/10.1002/cpdd.219 |
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