This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs).
Key questions:
* Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity? * What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity? * What is the risk of disease flaring with MTX withdrawal?
Adults (>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD).
Stable MTX dose ≥12 weeks.
Prednisone ≤5 mg/day.
Low disease activity/remission according to specific disease activity criteria.
Anaphylaxis to vaccine components.
Acute febrile illness.
Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease.
Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before.
University of Sao Paulo General Hospital
Lead sponsor
Insituto Adolfo Lutz
Collaborator