Published: 28 June 2022
Interrupting the treatment of vulnerable people on long-term immune supressing medicines for two weeks after a COVID-19 booster vaccination can double their antibody response to the jab, new research finds.
The VROOM trial will have implications for people on immune-supressing medicines, who are among the millions of clinically vulnerable patients advised to ‘shield’ during the pandemic. The study, funded by an NIHR and the Medical Research Council (MRC) partnership, and led by researchers at the University of Nottingham, is now published in the journal Lancet Respiratory Medicine.
Methotrexate is the most commonly used immune-suppressing drug, prescribed to around 1.3 million UK people for inflammatory conditions such as rheumatoid arthritis, and skin conditions such as psoriasis. Many 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 robust response to flu and pneumonia vaccines, including those against COVID-19.
The VROOM trial looked at the impact of interrupting methotrexate treatment for two-weeks on adults with autoimmune inflammatory conditions who had received their third-prime dose or COVID-19 booster jab.
Patients were recruited from 26 NHS hospitals across England and Wales. During the trial, 127 participants were asked to temporarily suspend methotrexate use for two weeks and 127 to continue using it as usual.
The study was planned to recruit 560 patients but recruitment was stopped early by the independent study oversight committees when interim results from the first 254 participants showed a clear result.
After four weeks and 12 weeks, they found the levels of spike-antibodies - which block the virus from infecting cells inside the body - was more than two-fold higher in the group where methotrexate was suspended for two-weeks following vaccination, compared to the group who continued use.
Chief Investigator, Professor Abhishek at the University of Nottingham and Honorary Consultant Rheumatologist at Nottingham University Hospitals NHS Trust, said: “We are extremely pleased with the initial results of the VROOM trial. There was a doubling of the antibody response in patients who held off on taking methotrexate for two weeks. The improvement in antibody response was maintained over a three-month period. There was a short-term increase in risk of flare-up of inflammatory conditions. However, most could be self-managed.
“We also saw no adverse impact on the quality of patient’s life following suspension of their medication. However, the study did not evaluate whether this strategy would result in fewer cases of COVID-19 or fewer hospitalisations due to COVID-19 as it was not large enough to detect these differences.
“Implementing these results could vastly improve the protection provided by boosters against COVID-19 for millions of people living with these conditions. Covid-19 has left them vulnerable to serious illness, whilst still having to live with the painful and troubling effects of their conditions. We hope this evidence is the next step in helping them with their lives going forward.”
Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccine Research Programme and Joint National Infection Specialty Lead, said: “Despite the majority of the UK population now being vaccinated, it remains as important as ever to continue ongoing research to ensure we can use vaccines effectively in different groups of patients.
“These landmark results provide high quality evidence to help best protect millions of people with compromised immune systems, keeping them safer from the virus and their existing chronic conditions.
“Thank you to all the participants who took part, we rely on their continued commitment to help us learn more and ultimately beat the virus.”
- The trial was funded through the Efficacy and Mechanism Evaluation (EME) Programme - an NIHR and MRC partnership - and supported by the NIHR’s Clinical Research Network (CRN).
- It was delivered in partnership with the University of Manchester, Imperial College London, the University of Oxford and Queen Mary University London and run by the Oxford Clinical Trials Research Unit (OCTRU).
- More information on the study is available on NIHR’s Funding and Awards website, and on the study website.