COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series
Authors' conclusion
In COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune Diseases, the Moderna Spikevax primary series was safe.
Study context
- Population
- Adults with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) on mycophenolate mofetil (MMF) or other rheumatic diseases on prednisone ≥10 mg/day, and age-/sex-matched healthy controls
- Participants
- 131 / 23 / 8 / 58
- Comparison
- Moderna Spikevax primary series in RA, SLE on MMF and other rheumatic diseases on prednisone vs age-/sex-matched healthy controls
- RAn = 131
- SLEn = 23
- Other rheumatic diseasesn = 8
- HCn = 58reference
Methodological detailsprospective, open-label, comparative, 12-month
- Prospective
- Open-label
- Comparative
- 12-month
Primary result
As reported in the abstract
Postvaccination immunogenicity (IgG positivity for anti-SARS-CoV-2 spike protein and RBD)
Further findings
Predictors of immunogenicity in RA
| OR (95% CI) | ||
|---|---|---|
| Age >65Negative predictor | 0.3 (0.1–0.8) | |
| RituximabNegative predictor | 0.003 (0.001–0.02) | |
| 0.050.21520Odds ratio (log scale) |
| Outcome | RA | SLE | HC | Estimate |
|---|---|---|---|---|
| Neutralising antibodies | 82.6% | 81.8% | — not stated in the abstract | |
| Positive ELISpot (cellular response)HC vs RA | (CI 11.2–53.3) | |||
| Tested | 52 | — not stated in the abstract | 26 | |
| Self-reported COVID-19 infection during study | 19 events | 3 events | 11 events |
— not stated in the abstract
Neutralising antibodies
- Reduced among patients
Safety
| Outcome | RA | SLE | HC | Estimate |
|---|---|---|---|---|
| Solicited self-reported AEs following vaccination | 86% | 90% | 90% | |
| Musculoskeletal AEsRA vs HC · more frequent in RA | 66% | — not stated in the abstract | 48% | (95% CI 3–32.6) |
— not stated in the abstract
Solicited self-reported adverse events (AEs) following vaccination
- Similar across groups
Vaccine-related serious AEs
- No vaccine-related serious AEs were reported
Disease activity scores postvaccination
- Did not increase postvaccination
Original publication
COVID-19 Vaccine in Immunosuppressed Adults with Autoimmune rheumatic Diseases (COVIAAD): safety, immunogenicity and antibody persistence at 12 months following Moderna Spikevax primary series. RMD Open. Published 29 November 2023. doi:10. 1136/ rmdopen-2023-003400
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