Trial reportArthritis & rheumatology (Hoboken, N.J.)2023
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.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06001606 (Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- 2024 Update of the Asia-Pacific League of Associations for Rheumatology (APLAR) Recommendations for Rheumatoid Arthritis Management.International journal of rheumatic diseases · 2026Guideline
- Brazilian Society of Rheumatology - 2025 recommendations on vaccination in immune-mediated rheumatic diseases.Advances in rheumatology (London, England) · 2026Guideline
- Rapid on-off effects of methotrexate on lymphocytes may facilitate recovery of suppressed vaccine immunogenicity after its short-term methotrexate discontinuation in rheumatoid arthritis.Frontiers in immunology · 2026Article
- Low vaccination uptake and attitudes towards COVID-19, influenza, and Streptococcus pneumoniae vaccines: a cross-sectional survey of patients with rheumatic diseases.Rheumatology international · 2025Article
- Vaccination Update and Specific Concerns for RA.Current rheumatology reports · 2025Review
- Infection Screening and Vaccination of Adult and Pediatric Patients with Autoimmune Inflammatory Rheumatic Diseases: An Emirati Delphi Consensus.Current rheumatology reviews · 2025Review
- Considerations for Pharmacologic Management of Rheumatoid Arthritis in the COVID-19 Era: a Narrative Review.Current rheumatology reports · 2023Review
- Cancer risks in rheumatoid arthritis patients who received immunosuppressive therapies: Will immunosuppressants work?Frontiers in immunology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis clinical trial was conducted to investigate whether discontinuing methotrexate (MTX) for 1 week after seasonal influenza vaccination is noninferior to discontinuing for 2 weeks after vaccination in patients with rheumatoid arthritis (RA).
methodsIn this multicenter, prospective, randomized, parallel-group noninferiority trial, RA patients receiving a stable dose of MTX were randomly assigned at a ratio of 1:1 to discontinue MTX for 1 week or for 2 weeks after they received the quadrivalent 2021-2022 seasonal influenza vaccine containing H1N1, H3N2, B/Yamagata, and B/Victoria strains. The primary outcome measure was the proportion of patients with a satisfactory vaccine response, which was defined as ≥4-fold increase in antibody titers, as determined with the hemagglutination inhibition assay, against ≥2 of the 4 vaccine strains at 4 weeks after vaccination.
resultsThe modified intent-to-treat population included 90 patients in the 1-week MTX hold group and 88 patients in the 2-week MTX hold group. The mean ± SD MTX doses were 12.6 ± 3.4 mg/week in the 1-week MTX hold group and 12.9 ± 3.3 mg/week in the 2-week MTX hold group. The proportion of satisfactory vaccine responses did not differ between the groups (68.9% versus 75.0%; P = 0.364). The rate of seroprotection and the fold increase in antibody titers for each of the 4 influenza antigens were similar between the groups.
conclusionA 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.
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