Reactogenicity, safety and disease flares following BNT162b2 mRNA COVID-19 vaccine in patients with chronic immune-inflammatory arthritis treated with biological and targeted synthetic disease-modifying anti-rheumatic drugs
Authors' conclusion
The safety of mRNA COVID-19 vaccination in arthritis patients on treatment with b/tsDMARDs is reassuring. In a regimen of peri-vaccine drug interruption, transient flares of the disease more commonly occur in association with active arthritis and use of shorter half-life drugs. Most flares do not require treatment escalation or change.
Study context
- Population
- Patients with RA, PsA and SpA treated with b/tsDMARDs receiving two doses of BNT162b2 mRNA COVID-19 vaccine
- Participants
- 186 vs 53
- Exposure
- Patients with chronic immune-inflammatory arthritis on b/tsDMARDs vs healthy controls
- Patients on b/tsDMARDsn = 186
- Healthy controlsn = 53reference
- Outcome
- Reactogenicity, safety and disease flares after each of the two vaccine doses
Methodological detailshealthy control comparison
- Healthy control comparison
Main finding
As reported in the abstract
Flares around vaccination
24.5%
Observational data: associations, not effects.
Further findings
Systemic reactogenicity with methotrexate use · after each vaccine dose
| aOR (95% CI) | ||
|---|---|---|
| Methotrexate useAfter first vaccine dose | 0.49 (0.25–0.94) | |
| Methotrexate useAfter second vaccine dose | 0.63 (0.32–0.99) | |
| 0.20.5125Adjusted odds ratio (log scale) |
Flares associated with active disease · after each vaccine dose
| aOR (95% CI) | ||
|---|---|---|
| Active diseaseAfter first vaccine dose | 2.8 (1.01–8.09) | |
| Active diseaseAfter second vaccine dose | 1.86 (0.99–6.03) | |
| 0.10.31310Adjusted odds ratio (log scale) |
Flares associated with JAKi use · after each vaccine dose
| aOR (95% CI) | ||
|---|---|---|
| JAKi useAfter first vaccine dose | 3.96 (1.39–11.27) | |
| JAKi useAfter second vaccine dose | 3.10 (0.99–7.85) | |
| 0.050.21520Adjusted odds ratio (log scale) |
Systemic reactogenicity with methotrexate use · after each vaccine dose
- No specific effects of different b/tsDMARDs on reactogenicity
Safety
Systemic events
- Frequency and severity similar to that reported in the general population; no particular safety concerns
Original publication
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