Evidence map›Paper›PMID 29572291›Full record

Trial reportAnnals of the rheumatic diseases2018

Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial.

Jin Kyun Park, Yun Jong Lee, Kichul Shin, You-Jung Ha, Eun Young Lee, Yeong Wook Song, Yunhee Choi, Kevin L Winthrop, Eun Bong Lee

4 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 111 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 12 pooled it
19.0field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02897011 naunknown statusnot on this map

Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2017Enrolled318ConditionsRheumatoid Arthritis, Influenza, MethotrexateArmsMethotrexate
NCT05069714 phase3completednot on this mapstarted 2021, after this paper: background citation

Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

TypeinterventionalSponsorSeoul National University HospitalRan2021 to 2022Enrolled184ConditionsRheumatoid Arthritis, Autoimmune Diseases, Influenza, Vaccine ReactionArmsMTX-hold
NCT05313061 phase3unknown statusnot on this mapstarted 2021, after this paper: background citation

Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study

TypeinterventionalSponsorSeoul National University HospitalRan2021 to 2022Enrolled40ConditionsRheumatoid ArthritisArmsMTX
NCT06001606 phase3unknown statusnot on this mapstarted 2023, after this paper: background citation

Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.

TypeinterventionalSponsorSeoul National University HospitalRan2023 to 2025Enrolled63ConditionsZoster, Systemic Lupus Erythematosus, Vaccine ReactionArmsShingrix, Placebo
3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 12 syntheses or guidelines pooled it, 210 citations in OpenAlex.

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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Jin Kyun ParkDivision of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Yun Jong LeeDivision of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.
Kichul ShinDepartment of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
You-Jung HaDivision of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.
Eun Young LeeDivision of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Yeong Wook SongDivision of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Yunhee ChoiDivision of Medical Statistics, Medical Research Collaborating Center, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Kevin L WinthropDivision of Infectious Diseases, Oregon Health and Science University, Portland, Oregon, USA.
Eun Bong LeeDivision of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Seoul National University · KRSeoul National University Bundang Hospital · KROregon Health & Science University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether a 2-week methotrexate (MTX) discontinuation after vaccination improves the efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis (RA).

methodsIn 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.

resultsThe 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.

conclusionsA 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 registrationNCT02897011.

Indexed as

AdultAgedAntibodies, ViralAntirheumatic AgentsArthritis, RheumatoidBetainfluenzavirusDeprescriptionsDrug Administration ScheduleFemaleHumansImmunogenicity, VaccineInfluenza A virusInfluenza, HumanInfluenza VaccinesMaleMethotrexateAntibodies, ViralAntirheumatic AgentsInfluenza VaccinesMethotrexatediscontinuationinfluenzamethotrexaterheumatoid arthritisvaccination

Identifiers

PMID29572291
PMCPMC5965360
OpenAlexW2792992921

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.