Across rheumatic diseases

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 OpenPublished Non-randomised controlled trial

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 predictor0.3 (0.1–0.8)
RituximabNegative predictor0.003 (0.001–0.02)
OutcomeRASLEHCEstimate
Neutralising antibodies82.6%81.8%— not stated in the abstract
Positive ELISpot (cellular response)HC vs RA(CI 11.2–53.3)
Tested52— not stated in the abstract26
Self-reported COVID-19 infection during study19 events3 events11 events

— not stated in the abstract

Neutralising antibodies

Reduced among patients

Safety

OutcomeRASLEHCEstimate
Solicited self-reported AEs following vaccination86%90%90%
Musculoskeletal AEsRA vs HC · more frequent in RA66%— not stated in the abstract48%(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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