Pausing immune-suppressing treatment doubles COVID-19 booster response

Interrupting the treatment of 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.

After four weeks and 12 weeks, levels of spike-antibodies - which block the virus from infecting cells inside the body - was more than two-times higher in the group who paused their treatment following vaccination, compared to the group who continued.

The VROOM 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 conditions such as rheumatoid arthritis and psoriasis. Many taking methotrexate were advised to shield during the first phase of the COVID-19 pandemic.

While methotrexate is effective at controlling conditions, it reduces the body’s ability to fight infections and generate robust responses to flu and pneumonia vaccines, including those against COVID-19.

The VROOM trial looked at the impact of interrupting methotrexate treatment for two weeks in adults with inflammatory conditions who had received their third COVID-19 jab.

A total 254 participants from 26 hospitals across England and Wales, including nine from the Nuffield Orthopaedic Centre, Oxford took part. Half stopped taking methotrexate for two weeks and half continued using it as usual.

The study planned to recruit 560 patients but was stopped early when interim results showed a clear result.

The trial’s Chief Investigator, Professor Abhishek Abhishek, 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.”

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).

Read more on the NIHR website.