To determine whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is non-inferior to discontinuing for 2 weeks in patients with rheumatoid arthritis (RA).
In this prospective randomized parallel-group multi-center non-inferiority trial study, RA patients on a stable dose of MTX were randomly assigned at a ratio of 1:1 to hold MTX for 1 week or 2 weeks after receiving the quadrivalent 2021–2022 seasonal influenza vaccine containing H1N1, H3N2, B-Yamagata, and B-Victoria strains. The primary outcome was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4-fold increase in hemagglutination inhibition antibody titers against two or more of the four vaccine strains 4 weeks after vaccination.
The modified intention-to-treat population included 90 patients in the 1 week MTX hold group and 88 patients in the 2 week MTX hold group. The MTX dose in the 1 week hold and the 2 week hold groups were 12.6 ± 3.4 and 12.9 ± 3.3 mg/week, respectively. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% vs. 75.0%, p = 0.364). The seroprotection rate and the fold increase in antibody titers to each of the four influenza antigens were similar between the groups.
Temporarily discontinuing MTX for 1 week is non-inferior to MTX discontinuation for 2 weeks after vaccination to induce a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA on a stable dose of MTX.