Cargando…
Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants
BACKGROUND: Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis. OBJECTIVE: The objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noni...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5696443/ https://www.ncbi.nlm.nih.gov/pubmed/29116597 http://dx.doi.org/10.1007/s40259-017-0249-y |
_version_ | 1783280452464803840 |
---|---|
author | Gomez, Elisa V. Bishop, Jessie L. Jackson, Kimberley Muram, Talia M. Phillips, Diane |
author_facet | Gomez, Elisa V. Bishop, Jessie L. Jackson, Kimberley Muram, Talia M. Phillips, Diane |
author_sort | Gomez, Elisa V. |
collection | PubMed |
description | BACKGROUND: Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis. OBJECTIVE: The objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noninferior to control. METHODS: In a randomized, open-label, parallel-group study, adult subjects received vaccinations alone (N = 42, control) or in combination with 160 mg IXE subcutaneously 2 weeks prior to vaccination and 80 mg IXE on the day of vaccination (N = 41, IXE). Response to tetanus vaccination was defined as anti-tetanus antibodies ≥ 1.0 IU and a ≥ 1.5-fold increase if baseline was ≤ 1.0 IU or a ≥ 2.5-fold increase if baseline was > 1.0 IU. Response to pneumococcal vaccination was defined as a ≥ 2-fold increase from baseline in anti-pneumococcal antibodies against > 50% of the 23 serotypes. The primary outcomes were the percentages of patients with a response to the tetanus and pneumococcal vaccines 4 weeks after vaccination. A noninferiority analysis of IXE to control using a 40% margin was evaluated for the primary outcomes. Safety and pharmacokinetics were also assessed. RESULTS: IXE (38 completers) was noninferior to control (41 completers) based on the difference in the proportion of responders to tetanus [1.4%; 90% confidence interval (CI) − 16.6 to 19.2] and pneumococcal (− 0.8%; 90% CI − 12.9 to 11.0) vaccines. Twenty subjects (14 IXE, six control) reported 43 mild treatment-emergent adverse events. CONCLUSION: IXE does not suppress the humoral immune response to non-live vaccines and was well tolerated in healthy subjects. ClinicalTrial.gov identifier: NCT02543918. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40259-017-0249-y) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5696443 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-56964432017-11-30 Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants Gomez, Elisa V. Bishop, Jessie L. Jackson, Kimberley Muram, Talia M. Phillips, Diane BioDrugs Original Research Article BACKGROUND: Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis. OBJECTIVE: The objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noninferior to control. METHODS: In a randomized, open-label, parallel-group study, adult subjects received vaccinations alone (N = 42, control) or in combination with 160 mg IXE subcutaneously 2 weeks prior to vaccination and 80 mg IXE on the day of vaccination (N = 41, IXE). Response to tetanus vaccination was defined as anti-tetanus antibodies ≥ 1.0 IU and a ≥ 1.5-fold increase if baseline was ≤ 1.0 IU or a ≥ 2.5-fold increase if baseline was > 1.0 IU. Response to pneumococcal vaccination was defined as a ≥ 2-fold increase from baseline in anti-pneumococcal antibodies against > 50% of the 23 serotypes. The primary outcomes were the percentages of patients with a response to the tetanus and pneumococcal vaccines 4 weeks after vaccination. A noninferiority analysis of IXE to control using a 40% margin was evaluated for the primary outcomes. Safety and pharmacokinetics were also assessed. RESULTS: IXE (38 completers) was noninferior to control (41 completers) based on the difference in the proportion of responders to tetanus [1.4%; 90% confidence interval (CI) − 16.6 to 19.2] and pneumococcal (− 0.8%; 90% CI − 12.9 to 11.0) vaccines. Twenty subjects (14 IXE, six control) reported 43 mild treatment-emergent adverse events. CONCLUSION: IXE does not suppress the humoral immune response to non-live vaccines and was well tolerated in healthy subjects. ClinicalTrial.gov identifier: NCT02543918. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40259-017-0249-y) contains supplementary material, which is available to authorized users. Springer International Publishing 2017-11-07 2017 /pmc/articles/PMC5696443/ /pubmed/29116597 http://dx.doi.org/10.1007/s40259-017-0249-y Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Gomez, Elisa V. Bishop, Jessie L. Jackson, Kimberley Muram, Talia M. Phillips, Diane Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title | Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title_full | Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title_fullStr | Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title_full_unstemmed | Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title_short | Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants |
title_sort | response to tetanus and pneumococcal vaccination following administration of ixekizumab in healthy participants |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5696443/ https://www.ncbi.nlm.nih.gov/pubmed/29116597 http://dx.doi.org/10.1007/s40259-017-0249-y |
work_keys_str_mv | AT gomezelisav responsetotetanusandpneumococcalvaccinationfollowingadministrationofixekizumabinhealthyparticipants AT bishopjessiel responsetotetanusandpneumococcalvaccinationfollowingadministrationofixekizumabinhealthyparticipants AT jacksonkimberley responsetotetanusandpneumococcalvaccinationfollowingadministrationofixekizumabinhealthyparticipants AT muramtaliam responsetotetanusandpneumococcalvaccinationfollowingadministrationofixekizumabinhealthyparticipants AT phillipsdiane responsetotetanusandpneumococcalvaccinationfollowingadministrationofixekizumabinhealthyparticipants |