Evidence map›Paper›PMID 35504634›Full record

ArticleBMJ open2022

Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study).

Abhishek Abhishek, R J Boyton, Áine McKnight, Laura Coates, James Bluett, Vicki S Barber, Lucy Cureton, Anne Francis, Duncan Appelbe, Lucy Eldridge and 8 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 34% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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

18 authors at 7 institutions in 1 country.

Abhishek AbhishekAcademic Rheumatology, University of Nottingham, Nottingham, UK Abhishek.abhishek@nottingham.ac.uk.ORCID 0000-0003-0121-4919
R J BoytonDepartment of Infectious Diseases, Imperial College London, London, UK.
Áine McKnightBlizard Institute, Centre for Genomics and Child Health, Queen Mary University of London, London, UK.
Laura CoatesNDORMS, University of Oxford, Oxford, UK.
James BluettManchester Academic Health Science Centre, Manchester, UK.
Vicki S BarberNDORMS, University of Oxford, Oxford, UK.
Lucy CuretonNDORMS, University of Oxford, Oxford, UK.
Anne FrancisNDORMS, University of Oxford, Oxford, UK.
Duncan AppelbeNDORMS, University of Oxford, Oxford, UK.
Lucy EldridgeNDORMS, University of Oxford, Oxford, UK.
Patrick JulierNDORMS, University of Oxford, Oxford, UK.
Nicholas PeckhamNDORMS, University of Oxford, Oxford, UK.
Ana M ValdesAcademic Rheumatology, University of Nottingham, Nottingham, UK.
Ines RombachOxford Clinical Trials Unit, Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford Nuffield, Oxford, UK.
Daniel M AltmannDepartment of Immunology and Inflammation, Imperial College London, London, UK.
Jonathan Nguyen-Van-TamPopulation and Lifespan Health, University of Nottingham, Nottingham, UK.
Hywel C WilliamsPopulation and Lifespan Health, University of Nottingham, Nottingham, UK.
Jonathan Alistair CookNDORMS, University of Oxford, Oxford, UK.ORCID 0000-0002-4156-6989
Nuffield Orthopaedic Centre · GBUniversity of Nottingham · GBHarefield Hospital · GBImperial College London · GBManchester Academic Health Science Centre · GBQueen Mary University of London · GBUniversity of Oxford · GB

Funding

Department of HealthMedical Research Council MR/V027883/1Medical Research Council MR/W020610/1
6 · The paper itself

Abstract

introductionIt is unknown if a temporary break in long-term immune-suppressive treatment after vaccination against COVID-19 improves vaccine response. The objective of this study was to evaluate if a 2-week interruption in low-dose weekly methotrexate treatment after SARS-CoV-2 vaccine boosters enhances the immune response compared with continuing treatment in adults with autoimmune inflammatory conditions. METHODS AND ANALYSIS: An open-label, pragmatic, prospective, parallel group, randomised controlled superiority trial with internal feasibility assessment and nested mechanistic substudy will be conducted in rheumatology and dermatology clinics in approximately 25 UK hospitals. The sample size is 560, randomised 1:1 to intervention and usual care arms. The main outcome measure is anti-spike receptor-binding domain (RBD) antibody level, collected at prebooster (baseline), 4 weeks (primary outcome) and 12 weeks (secondary outcome) post booster vaccination. Other secondary outcome measures are patient global assessments of disease activity, disease flares and their treatment, EuroQol 5- dimention 5-level (EQ-5D-5L), self-reported adherence with advice to interrupt or continue methotrexate, neutralising antibody titre against SARS-CoV-2 (mechanistic substudy) and oral methotrexate biochemical adherence (mechanistic substudy). Analysis of B-cell memory and T-cell responses at baseline and weeks 4 and 12 will be investigated subject to obtaining additional funding. The principal analysis will be performed on the groups as randomised (ie, intention to treat). The difference between the study arms in anti-spike RBD antibody level will be estimated using mixed effects model, allowing for repeated measures clustered within participants. The models will be adjusted for randomisation factors and prior SARS-CoV-2 infection status. ETHICS AND DISSEMINATION: This study was approved by the Leeds West Research Ethics Committee and Health Research Authority (REC reference: 21/HRA/3483, IRAS 303827). Participants will be required to give written informed consent before taking part in the trial. Dissemination will be via peer review publications, newsletters and conferences. Results will be communicated to policymakers. TRIAL REGISTRATION NUMBER: ISRCTN11442263.

Indexed as

COVID-19COVID-19 Drug TreatmentVaccinesCOVID-19 VaccinesEquivalence Trials as TopicHumansMethotrexateMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicSARS-CoV-2COVID-19 VaccinesMethotrexateVaccinesclinical trialsCOVID-19rheumatologY

Identifiers

PMID35504634
PMCPMC9066090
OpenAlexW4225326177

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.