BibTex format
@article{Abhishek:2022:10.1016/S2213-2600(22)00186-2,
author = {Abhishek, A and Boyton, RJ and Peckham, N and McKnight, Á and Coates, LC and Bluett, J and Barber, V and Cureton, L and Francis, A and Appelbe, D and Eldridge, L and Julier, P and Valdes, AM and Brooks, T and Rombach, I and Altmann, DM and Nguyen-Van-Tam, JS and Williams, HC and Cook, JA and VROOM, study investigators},
doi = {10.1016/S2213-2600(22)00186-2},
journal = {The Lancet Respiratory Medicine},
pages = {840--850},
title = {Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial},
url = {http://dx.doi.org/10.1016/S2213-2600(22)00186-2},
volume = {10},
year = {2022}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - BACKGROUND: Immunosuppressive treatments inhibit vaccine-induced immunity against SARS-CoV-2. We evaluated whether a 2-week interruption of methotrexate treatment immediately after the COVID-19 vaccine booster improved antibody responses against the S1 receptor-binding domain (S1-RBD) of the SARS-CoV-2 spike protein compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases. METHODS: We did an open-label, prospective, two-arm, parallel-group, multicentre, randomised, controlled, superiority trial in 26 hospitals in the UK. We recruited adults from rheumatology and dermatology clinics who had been diagnosed with an immune-mediated inflammatory disease (eg, rheumatoid arthritis, psoriasis with or without arthritis, axial spondyloarthritis, atopic dermatitis, polymyalgia rheumatica, and systemic lupus erythematosus) and who were taking low-dose weekly methotrexate (≤25 mg per week) for at least 3 months. Participants also had to have received two primary vaccine doses from the UK COVID-19 vaccination programme. We randomly assigned the participants (1:1), using a centralised validated computer randomisation program, to suspend methotrexate treatment for 2 weeks immediately after their COVID-19 booster (suspend methotrexate group) or to continue treatment as usual (continue methotrexate group). Participants, investigators, clinical research staff, and data analysts were unmasked, while researchers doing the laboratory analyses were masked to group assignment. The primary outcome was S1-RBD antibody titres 4 weeks after receiving the COVID-19 booster vaccine dose, assessed in the intention-to-treat population. This trial is registered with ISRCT, ISRCTN11442263; following the pre-planned interim analysis, recruitment was stopped early. FINDINGS: Between Sept 30, 2021 and March 3, 2022, we recruited 340 participants, of whom 254 were included in the interim analysis and had been randomly assigned to one of the two groups: 127 in the co
AU - Abhishek,A
AU - Boyton,RJ
AU - Peckham,N
AU - McKnight,Á
AU - Coates,LC
AU - Bluett,J
AU - Barber,V
AU - Cureton,L
AU - Francis,A
AU - Appelbe,D
AU - Eldridge,L
AU - Julier,P
AU - Valdes,AM
AU - Brooks,T
AU - Rombach,I
AU - Altmann,DM
AU - Nguyen-Van-Tam,JS
AU - Williams,HC
AU - Cook,JA
AU - VROOM,study investigators
DO - 10.1016/S2213-2600(22)00186-2
EP - 850
PY - 2022///
SN - 2213-2600
SP - 840
TI - Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial
T2 - The Lancet Respiratory Medicine
UR - http://dx.doi.org/10.1016/S2213-2600(22)00186-2
UR - https://www.ncbi.nlm.nih.gov/pubmed/35772416
UR - http://hdl.handle.net/10044/1/99297
VL - 10
ER -
