Tuesday, 12 December 2023
A major clinical trial, led by experts at the University of Nottingham, has shown that people with inflammatory conditions are able to improve the antibody response from a COVID-19 booster vaccination by interrupting their treatment for two weeks immediately after having the vaccine.
The antibody response to the jab was doubled at four weeks, and one and a half times greater at 26 weeks, when compared to those who continued with their treatment as usual. The improved antibody response lasted for six months. Patients who interrupted treatment reported experiencing more flare-ups of their inflammatory conditions in the next few weeks, but most flares were self-managed, and most didn’t need help from a healthcare provider.
The trial is funded by a National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC) partnership.
The interim findings of the Vaccine Response On Off Methotrexate (VROOM) trial (which was restricted to 250 patients and followed-up for 12 weeks) were previously published in Lancet Respiratory Medicine. They have already influenced the British and American clinical guidelines.
The full trial findings from 383 participants, which are published in Lancet Rheumatology, show that the improved protection lasts for six months. The full trial also shows that the blood from people who stopped methotrexate was also more efficient at killing the Wuhan strain and the Omnicron BA.1 variant. It also shows that when the six-month follow-up period was considered, there was no excess risk of disease flares in patients who suspended their treatment immediately after a COVID-19 booster vaccination.
These findings will be useful for national immunisation advisory committees, and other specialist societies formulating recommendations on the timing of vaccination in those treated with or starting medicines that turn down the immune system.
The VROOM trial recruited patients with a range of inflammatory conditions treated with methotrexate. Methotrexate is the most used immune-suppressing drug, with around 1.3 million people in the UK prescribed this medicine for inflammatory conditions such as rheumatoid arthritis, and skin conditions such as psoriasis. Many of them were among the 2.2 million clinically extremely vulnerable people advised to shield during the first phase of the COVID-19 pandemic, depending on specialist advice and on their risk factors.
While methotrexate is effective at controlling these conditions and has emerged as first line therapy for many illnesses, it reduces the body’s ability to fight infections and the ability to generate a robust response to flu and pneumonia vaccines, including those against COVID-19.
COVID-19 has not gone away, and with the emergence of new variants, and vaccine hesitancy among patients, it is important to optimise durable protection in people who are susceptible to COVID-19. Evidence from our trial will help patients and clinicians make informed choices about the risks and benefits of interrupting methotrexate treatment around the time of vaccination against COVID-19.”
Professor Danny McAuley, Scientific Director for NIHR Programmes, said: "As winter approaches, millions of people with compromised immune systems are still vulnerable to becoming unwell from COVID-19, despite the disease being less prevalent than it once was.
"This important research provides even more high quality evidence that by managing medicines in relation to vaccinations we can keep patients healthier while reducing pressure on the NHS.”
The study was carried out in collaboration with colleagues from the University of Manchester, Imperial College London, the University of Oxford, Queen Mary University London, UK Health Security Agency (formerly Public Health England) and participating NHS hospitals. The study was managed by the Oxford Clinical Trials Research Unit (OCTRU).
A free video explaining the study results is available here.
Story credits
The full study can be found here.
More information is available from Professor Abhishek from the University of Nottingham in the School of Medicine at abhishek.abhishek@nottingham.ac.uk
Notes to editors:
About the University of Nottingham
Ranked 32 in Europe and 16th in the UK by the QS World University Rankings: Europe 2024, the University of Nottingham is a founding member of the Russell Group of research-intensive universities. Studying at the University of Nottingham is a life-changing experience, and we pride ourselves on unlocking the potential of our students. We have a pioneering spirit, expressed in the vision of our founder Sir Jesse Boot, which has seen us lead the way in establishing campuses in China and Malaysia - part of a globally connected network of education, research and industrial engagement.
Nottingham was crowned Sports University of the Year by The Times and Sunday Times Good University Guide 2024 – the third time it has been given the honour since 2018 – and by the Daily Mail University Guide 2024.
The university is among the best universities in the UK for the strength of our research, positioned seventh for research power in the UK according to REF 2021. The birthplace of discoveries such as MRI and ibuprofen, our innovations transform lives and tackle global problems such as sustainable food supplies, ending modern slavery, developing greener transport, and reducing reliance on fossil fuels.
The university is a major employer and industry partner - locally and globally - and our graduates are the second most targeted by the UK's top employers, according to The Graduate Market in 2022 report by High Fliers Research.
We lead the Universities for Nottingham initiative, in partnership with Nottingham Trent University, a pioneering collaboration between the city’s two world-class institutions to improve levels of prosperity, opportunity, sustainability, health and wellbeing for residents in the city and region we are proud to call home.
More news…