Imperial College London
Alternate

ProfessorRosemaryBoyton

Faculty of Medicine, Department of Infectious Disease

Professor of Immunology and Respiratory Medicine
 
 
 
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Contact

 

r.boyton

 
 
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Location

 

8N22Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Abhishek:2022:10.1136/bmjopen-2022-062599,
author = {Abhishek, A and Boyton, RJ and McKnight, A and Coates, L and Bluett, J and Barber, VS and Cureton, L and Francis, A and Appelbe, D and Eldridge, L and Julier, P and Peckham, N and Valdes, AM and Rombach, I and Altmann, DM and Nguyen-Van-Tam, J and Williams, HC and Cook, JA},
doi = {10.1136/bmjopen-2022-062599},
journal = {BMJ Open},
title = {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)},
url = {http://dx.doi.org/10.1136/bmjopen-2022-062599},
volume = {12},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Introduction It 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
AU  - Abhishek,A
AU  - Boyton,RJ
AU  - McKnight,A
AU  - Coates,L
AU  - Bluett,J
AU  - Barber,VS
AU  - Cureton,L
AU  - Francis,A
AU  - Appelbe,D
AU  - Eldridge,L
AU  - Julier,P
AU  - Peckham,N
AU  - Valdes,AM
AU  - Rombach,I
AU  - Altmann,DM
AU  - Nguyen-Van-Tam,J
AU  - Williams,HC
AU  - Cook,JA
DO  - 10.1136/bmjopen-2022-062599
PY  - 2022///
SN  - 2044-6055
TI  - 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)
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2022-062599
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000790806100001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://bmjopen.bmj.com/content/12/5/e062599
UR  - http://hdl.handle.net/10044/1/97280
VL  - 12
ER  -
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