A major new clinical trial has been launched to investigate whether pausing immune-suppressing treatment can help vulnerable people to generate a stronger immune response to the COVID-19 vaccine.
Around 1.3 million people in the UK take methotrexate – a drug designed to suppress the immune system – to treat inflammatory conditions like rheumatoid arthritis, and skin conditions such as psoriasis. One drawback of methotrexate it that reduces the body’s ability to generate a robust immune response to vaccines.
The VROOM trial will see researchers recruit over 500 patients currently taking methotrexate, to see if their immune response to vaccination can be improved by taking a two-week break from this drug after receiving their booster jab for COVID-19. The study will also investigate the consequences of such a break on flare-ups of illness.
Figures suggest that people with inflammatory conditions such as those treated by methotrexate are 20-30% more likely to die or be hospitalised from COVID-19. Many of them are among the 2.2 million clinically extremely vulnerable people who were advised to shield during the first phase of the pandemic.
Research has previously found that a similar break from treatment can improve responses to the flu vaccine, but a lack of evidence about whether this would be true for the COVID-19 vaccines has resulted in conflicting advice and confusion for patients. This study will take the opportunity of the booster rollout to answer this question in relation to the Pfizer vaccine. It is expected to take between one and two years to complete.
Chief Investigator Professor Abhishek, Professor of Rheumatology at the University of Nottingham and Honorary Consultant Rheumatologist at Nottingham University Hospitals NHS Trust, said:
People with inflammatory conditions such as rheumatoid arthritis and skin diseases such as psoriasis face a daily battle dealing with painful and troubling effects of their illness. This can leave them unable to carry out daily tasks independently. At the same time, they face a double-edged sword of being more vulnerable to COVID-19, while potentially unable to mount the strongest possible immune response to vaccines against COVID-19, to protect them from the virus following their jab, leaving many of them still fearing the virus.
We hope to find out whether they can safely take a break from medications for their inflammatory conditions and an improved protection from the booster jab, without the risk of flare-up of their long-term illness which affects their daily lives so heavily.
Many people take methotrexate for more than 10-20 years, so we hope to provide high quality evidence which can help them with their day to day lives going forward.
Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said:
Although the vaccine rollout has saved many lives and helped drive down the effects of the pandemic, there are still groups of vulnerable people who can’t always mount robust immunity against the virus.
It’s important to establish if people can safely improve protection from their booster jabs by taking a break from their immune-supressing medicines, and this pivotal study will help develop our understanding of immune responses in people taking this widely prescribed medicine.
Once again NIHR is providing a critical role in the fight against COVID-19, funding ground-breaking research, while volunteers are participating in trials to help us learn more and ultimately beat the virus.
The study is funded through the Efficacy and Mechanism Evaluation (EME) Programme, which is a partnership between the National Institute for Health Research and the Medical Research Council. It will be led by a team at the University of Nottingham in partnership with the Oxford Clinical Trials Research Unit (OCTRU) at Oxford University, and will run in over 20 UK hospitals, with support from the NIHR’s Clinical Research Network.