Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial
Authors' conclusion
In patients with early rheumatoid arthritis, the PCV13 vaccine administered 1 month before methotrexate allowed for improved immunological responses without significant effect on disease control during one year of follow-up.
Study context
- Population
- Adults (18–80 years) with active early RA (DAS28 >3.2), naive to targeted disease-modifying anti rheumatic drugs (DMARDs), no MTX or LEF in past 3 months, no previous pneumococcal vaccination; 26 rheumatology departments in France249 in modified ITT
- Participants
- 276 adults
- Comparison
- PCV13 with MTX initiated 1 month later vs MTX initiated at the same time as PCV13
- Delayn = 126
- Immediaten = 123reference
- Primary endpoint
- Responder rate: positive responses (≥2-fold increase in IgG concentrations with ELISA or opsonophagocytic assay vs baseline) against at least three of five target serotypes (1, 3, 5, 7F, 19A)
- Follow-up
- 1 month
Methodological detailsmulticentre, open-label
- Multicentre
- Open-label
Primary result
As reported in the abstract
Responder rate
Delay vs ImmediateRelative risk (95% CI)P value
IgG concentrations; adjusted for sex and true DMARD naive status
1.46(1.10–1.92)
P = 0.02Opsonophagocytic assay activity; adjusted for sex and true DMARD naive status
1.65(1.25–2.19)
P = 0.01Further findings
Antibody functional activity · 12 months
- Significantly higher for eight of 13 serotypes in the delay group
Cumulative GC doses and targeted DMARD use
- Similar between groups throughout
RA disease activity score
- Remained comparable during follow-up
Safety
- Vaccine-related serious adverse events
- 1
- 72 (11%) of 649 adverse events were serious, in both groups, equally frequent between groups
Original publication
Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial. Lancet Rheumatol. Published 29 July 2025. doi:10.
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