Interrupting treatment of vulnerable people with immunosuppressive drugs doubles their antibody response to COVID-19 booster vaccination

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In view of the first results of the study, the independent steering committee of the study advised to stop new recruitments in the VROOM trial. Participants who took part in the VROOM study are invited to participate in an additional visit six months after their date of vaccination.

The peak antibody level reflects the strength of the antibody response. The research team is currently examining the quality of the antibody response by measuring its ability to kill live SARS-CoV-2 viruses and other variants of concern such as Omicron.

Chief Investigator Professor Abhishek of 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 delayed taking methotrexate for two weeks. The improvement in antibody response was maintained over a period of 3 months. There was a short-term increased risk of flare-ups of inflammatory conditions. However, most could be self-managed.

“We also saw no negative impact on patients’ quality of life following the suspension of their medication. However, the study did not assess whether this strategy would result in fewer COVID-19 cases or fewer COVID-19 hospitalizations because it was not large enough to detect these differences.

“Implementing these findings could significantly improve the protection offered by recalls against COVID-19 for millions of people living with these conditions. Covid-19 has left them vulnerable to serious illnesses, while having to live with the painful and unsettling effects of their conditions. We hope that this evidence is the next step to help them in their life to come. »

Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccine Research Program and Joint National Infections Specialty Lead and Honorary Clinical Chair at the University of Manchestersaid:

“Although the majority of the UK population is now vaccinated, it remains more important than ever to continue ongoing research to ensure that we can use vaccines effectively in different patient groups.

“These landmark results provide high-quality evidence to help protect millions of people with compromised immune systems as best as possible, further protecting them from the virus and their existing chronic conditions.”

“Thank you to all the participants who participated, we count on their continued commitment to help us learn more and ultimately beat the virus.”

Professor Rosemary Boyton, Co-Principal Candidate, Professor of Immunology and Respiratory Medicine, Department of Infectious Diseases, Imperial College London and Lung Division, Royal Brompton Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK, said, “This study is the first to report the efficacy of a two-week hiatus of an immunosuppressive drug called methotrexate immediately after COVID-19 booster vaccination in enhancing antibody-binding immunity against SAR- CoV-2. Our results showed a doubling of antibody levels, an increase that was sustained at 12 weeks. This has important implications for future vaccination strategy in this group of immunocompromised patients.

OCTRU’s academic lead, Associate Professor Jonathan Cook, based at the University of Oxford, said: “It’s nice to see the difference that a simple, cheap and modest adjustment to treatment can make. Clinical trials like VROOM are needed to help us understand how best to administer vaccines as a COVID-19 booster in different patient groups.

Professor John Iredale, executive chairman of the Medical Research Council, which part-funded the trial, said: “This important discovery means that many people who need to take immunosuppressive drugs now have a safe and effective way to improve their immune response to life. -saving COVID-19 vaccines. This study shows once again how the UK research community’s cutting-edge ability to rapidly set up well-designed clinical trials can provide the evidence needed to optimize medical interventions and save lives in the pandemic.

More information about the study is available at NIHR Funding and Awards Websiteand on the study site.

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