Patients can discontinue immunosuppressive drugs to boost immunity provided by COVID-19 booster, study finds

A major clinical trial, led by experts at the University of Nottingham, has shown that people with inflammatory diseases are able to improve the antibody response following a COVID-19 booster vaccination by stopping their treatment for two weeks immediately after receiving the vaccine.

The antibody response to the vaccine was doubled at four weeks and one and a half times higher at 26 weeks, compared to those who continued their treatment as usual. The enhanced antibody response lasted for six months.

Patients who discontinued treatment reported experiencing more flare-ups of their inflammatory diseases in the following weeks, but most flare-ups were self-managed and most did not require help from a healthcare professional. .

Interim results from the Vaccine Response On Off Methotrexate (VROOM) trial (which was limited to 250 patients and followed for 12 weeks) were previously published in Lancet Respiratory Medicine. They have already influenced British and American clinical guidelines.

The full results of the trial conducted with 383 participants, published in Lancet Rheumatology, show that the improved protection lasts six months. The full trial also shows that blood from people who stopped methotrexate was also more effective at killing the Wuhan strain and the omicron BA.1 variant. It also shows that when the six-month follow-up period was taken into account, there was no excessive risk of disease flares in patients who suspended treatment immediately after a COVID-19 booster vaccination. .

These findings will be useful to national immunization advisory committees and other specialist societies that will make recommendations on the timing of vaccination in people treated with or starting medications that weaken the immune system.

The VROOM trial enrolled patients with various inflammatory conditions treated with methotrexate. Methotrexate is the most widely used immunosuppressive medicine, with around 1.3 million people in the UK prescribed the 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 who were advised to protect themselves during the first phase of the COVID-19 pandemic, based on specialist advice and their risk factors.

Although methotrexate is effective in controlling these conditions and has become a first-line treatment for many illnesses, it reduces the body’s ability to fight infections and the ability to generate a robust response to influenza and influenza vaccines. pneumonia, including those against COVID-19.

Chief investigator Professor Abhishek from the University of Nottingham and honorary consultant rheumatologist at Nottingham University Hospitals NHS Trust, said: “COVID-19 has not gone away, and with the emergence of new variants and the Vaccination hesitancy among patients, it is important to optimize long-lasting protection in individuals susceptible to COVID-19. Evidence from our trial will help patients and clinicians make informed choices about the risks and benefits of discontinuing methotrexate treatment at the time of COVID-19 vaccination.

Professor Danny McAuley, Scientific Director of NIHR Programs, said: “As winter approaches, millions of people with compromised immune systems are still vulnerable to illness caused by COVID-19, although disease is less widespread than it was in the past.

“This important research provides even more qualitative evidence that by managing medicines in relation to vaccinations we can keep patients healthier whilst reducing pressure on the NHS.”

The study was carried out in collaboration with colleagues from the University of Manchester, Imperial College London, University of Oxford, Queen Mary University of London, UK Health Security Agency ( formerly Public Health England) and participating NHS hospitals. The study was led by the Oxford Clinical Trials Research Unit (OCTRU).