Evidence map›Paper›PMID 38258675›Full record

Trial reportThe Lancet. Rheumatology2024

Effectiveness of a fourth dose of COVID-19 mRNA vaccine in patients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs: an emulated target trial.

Jennifer S Hanberg, Xiaoqing Fu, Xiaosong Wang, Naomi J Patel, Yumeko Kawano, Abigail Schiff, Emily N Kowalski, Claire E Cook, Kathleen M M Vanni, Krishan Guzzo and 8 more

Open access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Rheumatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 3 institutions in 1 country.

Jennifer S HanbergDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Xiaoqing FuDivision of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, USA; Rheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Xiaosong WangDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Naomi J PatelDivision of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Yumeko KawanoDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Abigail SchiffDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Emily N KowalskiDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Claire E CookRheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Kathleen M M VanniDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Krishan GuzzoRheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Grace QianDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Katarina J BadeDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Alene SaavedraDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Rathnam VenkatDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
Shruthi SrivatsanRheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Yuqing ZhangDivision of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, USA; Rheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Jeffrey A SparksDivision of Rheumatology, Inflammation, and Immunity, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Zachary S WallaceDivision of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA, USA; Rheumatology and Allergy Clinical Epidemiology Research Center, Mongan Institute, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: zswallace@mgh.harvard.edu.
Brigham and Women's Hospital · USMassachusetts General Hospital · USHarvard University · US

Funding

VERITY: Value and Evidence in Rheumatology using bioInformaTics, and advanced analYticsP30AR072577 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Daniel Hal Solomon · 2017 to 2026
$9.8M
Joint Biology Consortium Resource-based CenterP30AR070253 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Peter A Nigrovic, Jeffrey Andrew Sparks · 2016 to 2026
$9.4M
Rheumatoid Arthritis-Related Autoantibodies, Articular Inflammation, and RA-Associated Interstitial Lung DiseaseR01AR077607 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI SPARKS, JEFFREY ANDREW · 2021 to 2025
$3.7M
Immunologic and Clinical Sequelae after COVID-19 in Patients with Systemic Autoimmune Rheumatic DiseasesR01AR080659 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Jeffrey Andrew Sparks · 2023 to 2026
$2.9M
Impact of ANCA Type and Rituximab vs. Cyclophosphamide on Cardiovascular Risk, Mortality, and Quality-Adjusted Life Years inANCA-Associated VasculitisK23AR073334 · NIAMS · MASSACHUSETTS GENERAL HOSPITAL · PI WALLACE, ZACHARY SCOTT · 2018 to 2022
$948k
Personalizing AAV Management by Leveraging Big Data: Targeting Complication ClustersR03AR078938 · NIAMS · MASSACHUSETTS GENERAL HOSPITAL · PI WALLACE, ZACHARY SCOTT · 2021 to 2022
$189k
NIAMS NIH HHS K23 AR073334NIAMS NIH HHS P30 AR070253NIAMS NIH HHS P30 AR072577NIAMS NIH HHS R01 AR077607NIAMS NIH HHS R01 AR080659NIAMS NIH HHS R03 AR078938
6 · The paper itself

Abstract

backgroundPatients with systemic autoimmune rheumatic diseases using disease-modifying antirheumatic drugs (DMARDs) might have blunted responses to COVID-19 vaccines. The initial mRNA vaccine series is defined as three doses for this population and a fourth booster dose is recommended. The effectiveness of the fourth dose in patients with systemic autoimmune rheumatic diseases using DMARDs is not well established. We aimed to assess the effectiveness of receiving versus not receiving a fourth dose of COVID-19 mRNA vaccine using a target trial framework, in a cohort of patients with systemic autoimmune rheumatic diseases receiving DMARD therapy.

methodsWe conducted an emulated target trial using observational data from the Mass General Brigham health-care system to compare receiving versus not receiving a fourth mRNA vaccine dose. Analysed patients had systemic autoimmune rheumatic diseases, were prescribed DMARDs, and were eligible for a fourth dose of BNT162b2 or mRNA-1273 vaccines between Jan 16 and June 11, 2022. To account for temporal changes, the study period was divided into 1-week intervals. Fourth-dose-exposed patients were included in a 1-week interval if they received a fourth mRNA dose in that interval; fourth-dose-unexposed patients were eligible for but had not received the fourth dose of the vaccine. The primary outcome was a SARS-CoV-2 infection; the secondary outcome was severe SARS-CoV-2 infection (ie, admission to hospital or death within -3 to +14 days of a positive test). We assessed the effectiveness of the fourth dose using time-stratified, overlap propensity score-weighted Cox regression models.

findingsWe included 4305 patients, 3126 of whom received a fourth dose of vaccine and 1179 who had not. The median follow-up time was 135 days (IQR 112-154) among patients who had received a fourth dose and 65 days (30-156) among patients who had not received a fourth dose. After overlap weighting in both groups, 1863 (72·7%) of 2563 participants were women, 700 (27·3%) were men, and 2242 (87·5%) were White. Rheumatoid arthritis was present in 1392 (54·3%) of 2563 participants; the most frequent treatments were conventional synthetic DMARDs (1489 [58·1%]) or biological DMARDs (1007 [39·3%]). SARS-CoV-2 infection risk was lower among patients receiving versus not receiving a fourth dose of vaccine (HR 0·59 [95% CI 0·47-0·74]). A fourth dose reduced the risk of admission to hospital or death within -3 to +14 days of SARS-CoV-2 infection (0·35 [0·14-0·85]).

interpretationIn this emulated target trial, a fourth dose of COVID-19 mRNA vaccine reduced the risk of SARS-CoV-2 infection and severe COVID-19 among patients with systemic autoimmune rheumatic diseases using DMARDs during the Omicron era. Patients with systemic autoimmune rheumatic diseases should be encouraged to remain up-to-date with COVID-19 vaccinations.

fundingThe National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidCOVID-19BNT162 VaccineCOVID-19 VaccinesFemaleHumansMalemRNA VaccinesRNA, MessengerSARS-CoV-2United StatesAntirheumatic AgentsBNT162 VaccineCOVID-19 VaccinesmRNA VaccinesRNA, Messenger

Identifiers

PMID38258675
PMCPMC10806341
OpenAlexW4388693955

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.