Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA

Objectives To assess vaccine effectiveness (VE) and safety of the recombinant zoster vaccine (RZV) in adults with systemic lupus erythematosus (SLE).Methods This retrospective study using administrative claims data collected between 1 January 2018 and 30 September 2023 from the USA included two coho...

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Main Authors: Alexis Ogdie, Michael D George, Huifeng Yun, Kristin Palmsten, Omar Ali, Cheryl N McMahill-Walraven, Aziza Jamal-Allial, Mano Selvan, Djeneba Audrey Djibo, Driss Oraichi, Sophie E Mayer, Sheryl A Kluberg, O’Mareen Spence, Harry Seifert, Andrew L Simon, Jenice S Ko, Caroline Hugh, Meg Her, Kathleen Shattuck, Kimberly Daniels, Qianli Ma, Rachel P Ogilvie, Najat Ziyadeh
Format: Article
Language:English
Published: BMJ Publishing Group 2025-08-01
Series:RMD Open
Online Access:https://rmdopen.bmj.com/content/11/3/e005839.full
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author Alexis Ogdie
Michael D George
Huifeng Yun
Kristin Palmsten
Omar Ali
Cheryl N McMahill-Walraven
Aziza Jamal-Allial
Mano Selvan
Djeneba Audrey Djibo
Driss Oraichi
Sophie E Mayer
Sheryl A Kluberg
O’Mareen Spence
Harry Seifert
Andrew L Simon
Jenice S Ko
Caroline Hugh
Meg Her
Kathleen Shattuck
Kimberly Daniels
Qianli Ma
Rachel P Ogilvie
Najat Ziyadeh
author_facet Alexis Ogdie
Michael D George
Huifeng Yun
Kristin Palmsten
Omar Ali
Cheryl N McMahill-Walraven
Aziza Jamal-Allial
Mano Selvan
Djeneba Audrey Djibo
Driss Oraichi
Sophie E Mayer
Sheryl A Kluberg
O’Mareen Spence
Harry Seifert
Andrew L Simon
Jenice S Ko
Caroline Hugh
Meg Her
Kathleen Shattuck
Kimberly Daniels
Qianli Ma
Rachel P Ogilvie
Najat Ziyadeh
author_sort Alexis Ogdie
collection DOAJ
description Objectives To assess vaccine effectiveness (VE) and safety of the recombinant zoster vaccine (RZV) in adults with systemic lupus erythematosus (SLE).Methods This retrospective study using administrative claims data collected between 1 January 2018 and 30 September 2023 from the USA included two cohorts of adults aged ≥18 years with SLE insured by (1) Medicare (parts A/B/D) or (2) one of five commercial partners (including Medicare Advantage plans). In VE analyses, adults receiving two RZV doses ≥28 days apart were matched 1:4 to unvaccinated comparators on insurer, sex and age (±5 years); the outcome was incident herpes zoster (HZ) after 31 days. In safety analyses, adults receiving RZV dose 1 or 2 were matched to unvaccinated comparators as above; the outcome was severe SLE flare within 90 days. Adjusted hazard ratios (HRs) were estimated using Cox models with inverse probability of treatment weighting (IPTW).Results VE cohorts included 2284 Medicare and 1308 commercially insured RZV-vaccinated patients; mean weighted follow-up was 1.4–1.6 person-years. Safety cohorts included 6602 RZV vaccinations (dose 1 or 2) in Medicare and 4196 in commercial insurers. Vaccinated versus unvaccinated patient characteristics were balanced after IPTW. VE was 70% (95% CI: 50% to 82%) in Medicare and 54% (95% CI: 18% to 74%) in commercially insured patients. The HR of severe SLE flare in vaccinated versus unvaccinated patients was 0.91 (95% CI: 0.75 to 1.11) in Medicare and 0.94 (95% CI: 0.72 to 1.24) in commercially insured patients.Conclusions RZV prevented a majority of HZ cases in individuals with SLE without increasing the risk of severe SLE flare.
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spelling doaj-art-ebab229f9d1a4683a1cd1a4a4d27c2602025-08-22T08:45:12ZengBMJ Publishing GroupRMD Open2056-59332025-08-0111310.1136/rmdopen-2025-005839Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USAAlexis Ogdie0Michael D George1Huifeng Yun2Kristin Palmsten3Omar Ali4Cheryl N McMahill-Walraven5Aziza Jamal-Allial6Mano Selvan7Djeneba Audrey Djibo8Driss Oraichi9Sophie E Mayer10Sheryl A Kluberg11O’Mareen Spence12Harry Seifert13Andrew L Simon14Jenice S Ko15Caroline Hugh16Meg Her17Kathleen Shattuck18Kimberly Daniels19Qianli Ma20Rachel P Ogilvie21Najat Ziyadeh2212 Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA12 Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, Pennsylvania, USA3 GSK, Rockville, Maryland, USA11 HealthPartners Institute, Bloomington, Minnesota, USA3 GSK, Rockville, Maryland, USA7 CVS Health Corp, Blue Bell, Pennsylvania, USA5 Carelon Research Inc, Wilmington, Delaware, USA8 Humana Healthcare Research, Louisville, Kentucky, USA7 CVS Health Corp, Blue Bell, Pennsylvania, USA3 GSK, Rockville, Maryland, USA2 Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA1 Department of Population Medicine, Harvard Medical School, Boston, Massachusetts, USA3 GSK, Rockville, Maryland, USA3 GSK, Rockville, Maryland, USA4 Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA4 Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA4 Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA4 Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA4 Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA5 Carelon Research Inc, Wilmington, Delaware, USA8 Humana Healthcare Research, Louisville, Kentucky, USA10 Optum, Boston, Massachusetts, USA10 Optum, Boston, Massachusetts, USAObjectives To assess vaccine effectiveness (VE) and safety of the recombinant zoster vaccine (RZV) in adults with systemic lupus erythematosus (SLE).Methods This retrospective study using administrative claims data collected between 1 January 2018 and 30 September 2023 from the USA included two cohorts of adults aged ≥18 years with SLE insured by (1) Medicare (parts A/B/D) or (2) one of five commercial partners (including Medicare Advantage plans). In VE analyses, adults receiving two RZV doses ≥28 days apart were matched 1:4 to unvaccinated comparators on insurer, sex and age (±5 years); the outcome was incident herpes zoster (HZ) after 31 days. In safety analyses, adults receiving RZV dose 1 or 2 were matched to unvaccinated comparators as above; the outcome was severe SLE flare within 90 days. Adjusted hazard ratios (HRs) were estimated using Cox models with inverse probability of treatment weighting (IPTW).Results VE cohorts included 2284 Medicare and 1308 commercially insured RZV-vaccinated patients; mean weighted follow-up was 1.4–1.6 person-years. Safety cohorts included 6602 RZV vaccinations (dose 1 or 2) in Medicare and 4196 in commercial insurers. Vaccinated versus unvaccinated patient characteristics were balanced after IPTW. VE was 70% (95% CI: 50% to 82%) in Medicare and 54% (95% CI: 18% to 74%) in commercially insured patients. The HR of severe SLE flare in vaccinated versus unvaccinated patients was 0.91 (95% CI: 0.75 to 1.11) in Medicare and 0.94 (95% CI: 0.72 to 1.24) in commercially insured patients.Conclusions RZV prevented a majority of HZ cases in individuals with SLE without increasing the risk of severe SLE flare.https://rmdopen.bmj.com/content/11/3/e005839.full
spellingShingle Alexis Ogdie
Michael D George
Huifeng Yun
Kristin Palmsten
Omar Ali
Cheryl N McMahill-Walraven
Aziza Jamal-Allial
Mano Selvan
Djeneba Audrey Djibo
Driss Oraichi
Sophie E Mayer
Sheryl A Kluberg
O’Mareen Spence
Harry Seifert
Andrew L Simon
Jenice S Ko
Caroline Hugh
Meg Her
Kathleen Shattuck
Kimberly Daniels
Qianli Ma
Rachel P Ogilvie
Najat Ziyadeh
Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
RMD Open
title Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
title_full Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
title_fullStr Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
title_full_unstemmed Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
title_short Effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus: a claims-based retrospective cohort study in the USA
title_sort effectiveness and safety of the recombinant zoster vaccine in adult patients with systemic lupus erythematosus a claims based retrospective cohort study in the usa
url https://rmdopen.bmj.com/content/11/3/e005839.full
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