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Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials

INTRODUCTION: The risk of herpes zoster (HZ) is associated with a decline in immune system function, linked to aging and/or immunocompromising or immunosuppressive diseases or therapies. In this post hoc analysis we describe the incidence of HZ, rash characteristics, and burden of HZ pain in immunoc...

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Autores principales: Curran, Desmond, Matthews, Sean, Boutry, Céline, Lecrenier, Nicolas, Cunningham, Anthony L., Schmader, Kenneth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9669262/
https://www.ncbi.nlm.nih.gov/pubmed/36322332
http://dx.doi.org/10.1007/s40121-022-00689-7
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author Curran, Desmond
Matthews, Sean
Boutry, Céline
Lecrenier, Nicolas
Cunningham, Anthony L.
Schmader, Kenneth
author_facet Curran, Desmond
Matthews, Sean
Boutry, Céline
Lecrenier, Nicolas
Cunningham, Anthony L.
Schmader, Kenneth
author_sort Curran, Desmond
collection PubMed
description INTRODUCTION: The risk of herpes zoster (HZ) is associated with a decline in immune system function, linked to aging and/or immunocompromising or immunosuppressive diseases or therapies. In this post hoc analysis we describe the incidence of HZ, rash characteristics, and burden of HZ pain in immunocompetent adults ≥ 50 years of age (YOA) and in hematopoietic stem cell transplantation (HSCT) recipients ≥ 18 YOA. METHODS: ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) were phase III, observer-blind, placebo-controlled, randomized studies conducted in immunocompetent adults ≥ 50 YOA and ≥ 70 YOA; and in HSCT recipients ≥ 18 YOA, respectively. A similar methodology for study design, case definition, and data collection were applied in all three studies. The participants received either two doses of the adjuvanted recombinant zoster vaccine or placebo, 1–2 months apart. This analysis focuses on all confirmed HZ cases from the placebo groups of the three studies. HZ pain and interference with activities of daily living were assessed using the Zoster Brief Pain Inventory instrument. RESULTS: Overall, 280, 240, and 172 placebo participants with an HZ confirmed episode aged ≥ 50, ≥ 70, and ≥ 18 YOA were included in the ZOE-50, ZOE-70, and ZOE-HSCT analyses, respectively. The incidence of HZ was 9.1/1000 person-years in both the ZOE-50 and ZOE-70 placebo groups and 95.6/1000 person-years in the ZOE-HSCT study placebo group. In the three studies, most individuals with HZ had severe pain, with approximately 90% of individuals reporting clinically significant pain. An estimated 12.3%, 16.9%, and 21.8% of patients in the ZOE-50, ZOE-70, and ZOE-HSCT studies, respectively, developed post-herpetic neuralgia. CONCLUSION: The incidence and burden of HZ is high in immunocompetent adults aged ≥ 50 YOA and even more so in HSCT recipients aged ≥ 18 YOA. GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00689-7.
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spelling pubmed-96692622022-11-30 Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials Curran, Desmond Matthews, Sean Boutry, Céline Lecrenier, Nicolas Cunningham, Anthony L. Schmader, Kenneth Infect Dis Ther Original Research INTRODUCTION: The risk of herpes zoster (HZ) is associated with a decline in immune system function, linked to aging and/or immunocompromising or immunosuppressive diseases or therapies. In this post hoc analysis we describe the incidence of HZ, rash characteristics, and burden of HZ pain in immunocompetent adults ≥ 50 years of age (YOA) and in hematopoietic stem cell transplantation (HSCT) recipients ≥ 18 YOA. METHODS: ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) were phase III, observer-blind, placebo-controlled, randomized studies conducted in immunocompetent adults ≥ 50 YOA and ≥ 70 YOA; and in HSCT recipients ≥ 18 YOA, respectively. A similar methodology for study design, case definition, and data collection were applied in all three studies. The participants received either two doses of the adjuvanted recombinant zoster vaccine or placebo, 1–2 months apart. This analysis focuses on all confirmed HZ cases from the placebo groups of the three studies. HZ pain and interference with activities of daily living were assessed using the Zoster Brief Pain Inventory instrument. RESULTS: Overall, 280, 240, and 172 placebo participants with an HZ confirmed episode aged ≥ 50, ≥ 70, and ≥ 18 YOA were included in the ZOE-50, ZOE-70, and ZOE-HSCT analyses, respectively. The incidence of HZ was 9.1/1000 person-years in both the ZOE-50 and ZOE-70 placebo groups and 95.6/1000 person-years in the ZOE-HSCT study placebo group. In the three studies, most individuals with HZ had severe pain, with approximately 90% of individuals reporting clinically significant pain. An estimated 12.3%, 16.9%, and 21.8% of patients in the ZOE-50, ZOE-70, and ZOE-HSCT studies, respectively, developed post-herpetic neuralgia. CONCLUSION: The incidence and burden of HZ is high in immunocompetent adults aged ≥ 50 YOA and even more so in HSCT recipients aged ≥ 18 YOA. GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00689-7. Springer Healthcare 2022-11-02 2022-12 /pmc/articles/PMC9669262/ /pubmed/36322332 http://dx.doi.org/10.1007/s40121-022-00689-7 Text en © GSK 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Curran, Desmond
Matthews, Sean
Boutry, Céline
Lecrenier, Nicolas
Cunningham, Anthony L.
Schmader, Kenneth
Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title_full Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title_fullStr Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title_full_unstemmed Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title_short Natural History of Herpes Zoster in the Placebo Groups of Three Randomized Phase III Clinical Trials
title_sort natural history of herpes zoster in the placebo groups of three randomized phase iii clinical trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9669262/
https://www.ncbi.nlm.nih.gov/pubmed/36322332
http://dx.doi.org/10.1007/s40121-022-00689-7
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