TOPLINE:
Patients with early rheumatoid arthritis (RA) who delayed starting methotrexate for a month to receive the 13-valent pneumococcal conjugate vaccine (PCV13) did not have worse disease control, more radiographic progression, or greater need for treatment escalation over 1 year than those who started methotrexate immediately.
METHODOLOGY:
- Researchers conducted an ancillary analysis of the VACIMRA trial at a French centre to assess whether a 1-month delay in methotrexate initiation after vaccination with the PCV13 improved vaccine response without compromising RA control.
- They analysed data from 96 patients with recent-onset RA and moderate disease activity, recruited between September 2013 and July 2019. The mean age of the patients at diagnosis was 58 years, and about two thirds were women.
- Patients were randomly assigned to start methotrexate at inclusion (immediate group) or 1 month after receiving the PCV13 (delay group), with both groups permitted low-dose corticosteroids and given a PPSV23 booster at 2 months.
- The primary outcome was remission or low disease activity at 12 months. Remission was defined as a disease activity score in 28 joints using erythrocyte sedimentation rate (DAS28‑ESR) < 2.6, and low disease activity was defined as DAS28‑ESR ≤ 3.2.
- Secondary outcomes included differences in treatments and therapeutic escalation. Additionally, radiographic progression was assessed using changes in the modified Sharp-van der Heijde score.
TAKEAWAY:
- At 12 months, similar proportions of patients in the immediate and delay groups achieved remission (46.3% vs 53.7%) and low disease activity (61.0% vs 75.6%), with no significant differences.
- Mean DAS28-ESR scores were similar in both groups at months 1 and 3 but lower in the delay vs immediate group at months 6 (2.66 vs 3.28; P = .02) and 12 (2.23 vs 3.00; P < .01); these differences were no longer significant after correction for multiple testing.
- Radiographic progression was comparable between the groups at 6 and 12 months, with no significant difference in the proportion of patients showing progression.
- Methotrexate doses, corticosteroid exposure, and the proportion of patients receiving targeted therapies were similar between the groups during follow-up.
IN PRACTICE:
"In clinical practice, for patients with early RA and moderate disease activity, it appears feasible to administer recommended vaccinations while delaying methotrexate initiation by one month to enhance elicited immune responses, using low-dose corticosteroids (< 10 mg/day) when needed, without adversely affecting disease activity or radiographic progression during the first year," the authors of the study wrote.
SOURCE:
The study was led by Theresa Than, University of Montpellier, Montpellier, France. It was published online on May 22, 2026, in Rheumatology.
LIMITATIONS:
The sample size was not calculated to assess clinical and structural progression outcomes. The 1-year follow‑up duration was inadequate to assess long-term outcomes. Not all analyses were adjusted for multiple testing.
DISCLOSURES:
The study received funding from the Government of France and Pfizer. Pfizer provided PCV13 supply and participated in laboratory analyses. Several authors reported receiving consulting fees, honoraria, travel support, or research funding from pharmaceutical companies, including Pfizer, or serving in advisory roles for these companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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