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Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial
Open accessAbstract
OBJECTIVE: To determine whether a 2-week methotrexate (MTX) discontinuation after vaccination improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA). METHODS: In this prospective randomised parallel-group multicentre study, patients with RA on stable dose of MTX were randomly assigned at a ratio of 1:1 to continue MTX or to hold MTX for 2 weeks after 2016-2017 quadrivalent seasonal influenza vaccine containing H1N1, H3N2, B-Yamagata and B-Victoria. The primary outcome was frequency of satisfactory vaccine response, defined as greater than or equal to fourfold increase of haemagglutination inhibition (HI) antibody titre at 4 weeks after vaccination against ≥2 of four vaccine strains. Secondary endpoints included seroprotection (ie, HI titre ≥1:40) rate, fold change in antibody titres. RESULTS: The modified intention-to-treat population included 156 patients in the MTX-continue group and 160 patients in the MTX-hold group. More patients in MTX-hold group achieved satisfactory vaccine response than the MTX-continue group (75.5% vs 54.5%, p<0.001). Seroprotection rate was higher in the MTX-hold group than the MTX-continue group for all four antigens (H1N1: difference 10.7%, 95% CI 2.0% to 19.3%; H3N2: difference 15.9%, 95% CI 5.9% to 26.0%; B-Yamagata: difference13.7%, 95% CI 5.2% to 22.4%; B-Victoria: difference 14.7%, 95% CI 4.5% to 25.0%). The MTX-hold group showed higher fold increase in their antibody titres against all four influenza antigens (all p<0.05). Change in disease activity was similar between groups. CONCLUSIONS: A temporary MTX discontinuation for 2 weeks after vaccination improves the immunogenicity of seasonal influenza vaccination in patients with RA without increasing RA disease activity. TRIAL REGISTRATION: NCT02897011.
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Stopping MTX for 2 weeks after influenza vaccination improved immunogenicity in RA patients.
“Temporary discontinuation of MTX for 2 weeks after vaccination improved the immunogenicity of influenza vaccination in patients with RA.21 22”
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“19 In our previous pilot work, vaccine immunogenicity of trivalent influenza vaccine was significantly improved in patients with RA on stable dose of MTX, when MTX was suspended for 2 weeks before and 2 weeks after vaccination or 4 weeks after vaccination but not when it was suspended for 4 weeks…”
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Metadata
- Authors
- Park, J. K., Lee, Y. J., Shin, K., Ha, Y.-J., Lee, E. Y., Song, Y. W., Choi, Y., Winthrop, K. L., & Lee, E. B.
- Affiliations
- Seoul National University (KR)
- Seoul National University Bundang Hospital (KR)
- Oregon Health & Science University (US)
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2018-06
- Volume
- 77
- Issue
- 6
- Pages
- 898-904
- ISSN
- 0003-4967 (ISSN-L)
- PMC
- PMC5965360
- OpenAlex
- W2792992921
- Cited by
- 217
- References
- 21
- Citations by year
- 2026: 15 · 2025: 11 · 2024: 23 · 2023: 29 · 2022: 47 · 2021: 57 · 2020: 18 · 2019: 10 · 2018: 6
- FWCI
- 17.69
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Annals of the Rheumatic Diseases (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- Green Cross Corporation
- Topics
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- methotrexate, rheumatoid arthritis, seasonal influenza vaccine, vaccine immunogenicity, drug discontinuation, quadrivalent influenza vaccine, hemagglutination inhibition antibodies, seroprotection, disease activity, immunosuppression
- MeSH terms
- Deprescriptions, Immunogenicity, Vaccine, Adult, Aged, Antibodies, Viral, Arthritis, Rheumatoid, Drug Administration Schedule, Female, Humans, Influenza, Human, Influenza Vaccines, Male, Methotrexate, Middle Aged, Influenza A virus, Prospective Studies, Seasons, Vaccination, Single-Blind Method, Antirheumatic Agents, Betainfluenzavirus, Young Adult
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