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
Main finding · SARS-CoV-2 infectionResult — go to the resultHazard ratio 0.59 95% CI 0.47–0.74Authors' conclusion
In 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.
Study context
- Population
- Patients with systemic autoimmune rheumatic diseases prescribed disease-modifying antirheumatic drugs (DMARDs), eligible for a fourth mRNA dose between Jan 16 and June 11, 2022, Mass General Brigham health-care system2,563 after overlap weighting
- Participants
- 4,305 patients
- Exposure
- Fourth COVID-19 mRNA vaccine dose vs no fourth dose
- Fourth dosen = 3,126
- No fourth dosen = 1,179reference
- Outcome
- SARS-CoV-2 infection
Methodological detailsobservational data, time-stratified, overlap propensity score-weighted Cox regression, 1-week intervals
- Observational data
- Time-stratified, overlap propensity score-weighted Cox regression
- 1-week intervals
Main finding
As reported in the abstract
Hazard ratio
0.59
95% CI 0.47–0.74
Fourth dosevs No fourth dose
HR 0.59 (95% CI 0.47–0.74)
Observational data: associations, not effects.
Secondary outcomes
| Outcome | HR (95% CI) | |
|---|---|---|
| Severe SARS-CoV-2 infection (hospital admission or death within −3 to +14 days of a positive test) | 0.35 (0.14–0.85) | |
| 0.10.31310Hazard ratio (log scale) |
Follow-up time
Original publication
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. Lancet Rheumatol. Published 15 November 2023. doi:10.
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