Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial
Abstract
Objective To investigate whether temporary discontinuation of methotrexate (MTX) improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).Methods In this prospective randomised parallel-group trial, patients with RA taking stable dose of MTX were randomly assigned at a ratio of 1:1:1:1 to continue MTX (group 1), suspend MTX for 4 weeks before vaccination (group 2), suspend MTX for 2 weeks before and 2 weeks after vaccination (group 3) or suspend MTX for 4 weeks after vaccination (group 4). All participants were vaccinated with trivalent influenza vaccine containing H1N1, H3N2 and B-Yamagata. The primary outcome was frequency of satisfactory vaccine response (≥4-fold titre increase 4 weeks postvaccination). Secondary endpoints included fold change in antibody titres from baseline.Results The per-protocol population consisted of 199 patients (n=54, 44, 49 and 52 in groups 1, 2, 3 and 4, respectively). Group 3 achieved higher satisfactory vaccine response against all three antigens than group 1 (51.0% vs 31.5%, p=0.044). The anti-H3N2 antibody fold increase (95% CI) was significantly higher in groups 3 and 4 (12.2 (8.4 to 17.5), p <0.001 and 10.0 (6.8 to 14.8), p=0.043, respectively) than group 1 (5.9 (4.3 to 8.1)). The anti-B-Yamagata antibody responses of groups 3 and 4 were higher (4.7 (3.3 to 6.7), p=0.048; 6.1 (4.2 to 8.8), p <0.001, respectively) than group 1 (2.9 (2.2 to 3.8)). RA flare occurred in 24.1%, 21.2%, 34.1% and 38.8% in groups 1, 2, 3 and 4, respectively (p=NS).Conclusions Temporary MTX discontinuation improves the immunogenicity of seasonal influenza vaccination in patients with RA.Trial registration Trial registration number is: www.clinicaltrials.gov, NCT02748785.
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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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- Authors
- Park, J. K., Lee, M. A., Lee, E. Y., Song, Y. W., Choi, Y., Winthrop, K. L., & Lee, E. B.
- Affiliations
- Seoul National University (KR)
- Oregon Health & Science University (US)
- Corresponding author
- Lee, Eun Young
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 76
- Issue
- 9
- Pages
- 1559-1565
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2610310220
- Cited by
- 136
- References
- 30
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 17 · 2023: 16 · 2022: 29 · 2021: 27 · 2020: 11 · 2019: 11 · 2018: 10 · 2017: 2
- FWCI
- 8.13
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- National Research Foundation of Korea
- Topics
- Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
- Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- methotrexate, rheumatoid arthritis, seasonal influenza vaccination, vaccine immunogenicity, drug discontinuation, antibody response, H3N2, B/Yamagata, trivalent influenza vaccine, immunosuppression, vaccine response
- MeSH terms
- Deprescriptions, Immunogenicity, Vaccine, Aged, Antibodies, Viral, Arthritis, Rheumatoid, Drug Administration Schedule, Female, Humans, Influenza, Human, Influenza Vaccines, Male, Methotrexate, Middle Aged, Influenza B virus, Time Factors, Antirheumatic Agents, Influenza A Virus, H1N1 Subtype, Influenza A Virus, H3N2 Subtype
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