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Trial investigates whether immunosuppressant holiday boosts vaccine protection

pharmafile | November 12, 2021 | News story | Medical Communications  

A trial has been launched to evaluate how to increase COVID-19 vaccine protection among vulnerable patients taking immunosuppressant drugs . Researchers from the University of Nottingham, in partnership with other universities and hospitals, are set to recruit 560 patients for the study, whose immune systems have been weakened by methotrexate for the treatment of other health conditions.

Around 1.3 million people in the UK take methotrexate, which slows down the body’s immune system and helps reduce inflammation. It is used to treat inflammatory conditions including Chron’s disease, rheumatoid arthritis, and psoriasis. It can also be prescribed for other autoimmune conditions such as sarcoidosis. The medication leaves the body less able to fight infections or respond to vaccines, and data shows that those with inflammatory conditions are 1.2 to 1.3 times more likely to die or be hospitalised from COVID-29.

The researchers will investigate whether a 2 week break from the drug immediately after the COVID-19 booster jab will produce a more robust immune response, and increase vaccine efficacy.

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Professor Abhishek Abhishek, chief investigator and Professor of Rheumatology at the University of Nottingham, shared that those with inflammatory conditions are more vulnerable to COVID-19 while also unable to have a strong immune response to vaccination. He stated: “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.”

The researchers are funded by the National Institute for Health Research (NIHR) and the Medical Research Council. The study is being run at 20 hospitals, and participants will have the Pfizer-BioNTech vaccine administered as their booster jab.

Professor Andy Ustianowski, from the NIHR, stated: “This pivotal study will help develop our understanding of immune responses in people taking this widely prescribed medicine.” Although the study will take up to two years to complete, it is hoped that the research will reassure the most vulnerable patients at risk from COVID-19.

Ana Ovey

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