Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial.

Journal: The Lancet. Rheumatology
PMID:

Abstract

BACKGROUND: Methotrexate is the first-line treatment for immune-mediated inflammatory diseases and reduces vaccine-induced immunity. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster vaccination improved antibody response against the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein and live SARS-CoV-2 neutralisation compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases.

Authors

  • Abhishek Abhishek
    Academic Rheumatology, University of Nottingham, Nottingham, UK. Electronic address: abhishek.abhishek@nottingham.ac.uk.
  • Nicholas Peckham
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Corinna Pade
    Blizard Institute, Centre for Genomics and Child Health, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
  • Joseph M Gibbons
    Blizard Institute, Centre for Genomics and Child Health, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
  • Lucy Cureton
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Anne Francis
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Vicki Barber
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Jennifer A E Williams
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Duncan Appelbe
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Lucy Eldridge
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Patrick Julier
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
  • Daniel M Altmann
    Department of Inflammation and Immunology, Imperial College London, London, UK.
  • James Bluett
    NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester UK; Versus Arthritis Centre for Genetics and Genomics, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK.
  • Tim Brooks
    UK Health Security Agency, UK.
  • Laura C Coates
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Biomedical Research Centre, Oxford, UK.
  • Ines Rombach
    Sheffield Clinical Trials Research Unit, School of Health and Related Research, University of Sheffield, UK.
  • Amanda Semper
    UK Health Security Agency, UK.
  • Ashley Otter
    UK Health Security Agency, UK.
  • Ana M Valdes
    Academic Rheumatology, University of Nottingham, Nottingham, UK.
  • Jonathan S Nguyen-Van-Tam
    Population and Lifespan Health, University of Nottingham, Nottingham, UK.
  • Hywel C Williams
    Population and Lifespan Health, University of Nottingham, Nottingham, UK.
  • Rosemary J Boyton
    Department of Infectious Disease, Imperial College London, London, UK; Lung Division, Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Áine McKnight
    Blizard Institute, Centre for Genomics and Child Health, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
  • Jonathan A Cook
    Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK; Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.