A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis
Authors' conclusion
A temporary discontinuation of MTX for 1 week after vaccination was noninferior to a discontinuation of MTX for 2 weeks after vaccination, regarding induction of a satisfactory vaccine response to a seasonal influenza vaccine in patients with RA receiving a stable dose of MTX.
Study context
- Population
- Rheumatoid arthritis (RA) patients receiving a stable dose of methotrexate (MTX), vaccinated with quadrivalent (H1N1, H3N2, B/Yamagata, B/Victoria) seasonal influenza vaccinemodified ITT population
- Participants
- 90 vs 88
- Comparison
- MTX discontinuation for 1 week vs 2 weeks after seasonal influenza vaccination
- 1-week MTX holdn = 90
- 2-week MTX holdn = 88reference
- Primary endpoint
- Proportion with satisfactory vaccine response: ≥4-fold increase in hemagglutination inhibition antibody titers against ≥2 of the 4 vaccine strains
- Follow-up
- 4 weeks after vaccination
Methodological detailsmulticenter, prospective, parallel-group, noninferiority, 1:1 randomisation
- Multicenter
- Prospective
- Parallel-group
- Noninferiority
- 1:1 randomisation
Primary result
As reported in the abstract
Satisfactory vaccine response (≥4-fold increase in HI antibody titers against ≥2 of 4 strains)
- 1-week MTX hold vs 2-week MTX hold: P = 0.364
- Modified intent-to-treat population
- Noninferiority trial
Further findings
Seroprotection rate and fold increase in antibody titers for each of the 4 influenza antigens
- Similar between the groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A Multicenter, Prospective, Randomized, Parallel‐Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. Published 7 December 2022. doi:10.
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