ARE patients being treated for inflammatory bowel disease (IBD) at increased risk from Covid-19?

That's what a major new study, launched in the South West, is aiming to find out.

The CLARITY Study is being run by the IBD research team at the Royal Devon and Exeter NHS Foundation Trust and the University of Exeter Medical School, supported by the NIHR (National Institute for Health Research) Clinical Research Network in the South West.

The study aims to look at the development of antibodies to SARS-CoV-2 (the virus that causes Covid-19) in patients with IBD - the umbrella term for Crohn’s disease and ulcerative colitis - which affects more than 500,000 people in the UK.

Researchers will test samples from approximately 15,000 patients collected since the start of 2020 for antibodies against the virus, while also following almost 7,000 patients who are receiving infliximab or vedolizumab, testing for antibodies against the virus every eight weeks.

Use of common IBD drugs, including biologic medicines and immunomodulators meant that a significant proportion of the 500,000 people across the UK were categorised during the first national lockdown in March as being at higher risk of serious complications from Covid-19.

Tariq Ahmad, consultant gastroenterologist at Royal Devon and Exeter NHS Foundation Trust, and the chief investigator of the study, said: “Immunosuppressive and biologic drugs are effective at reducing inflammation and improving symptoms for most patients with IBD.

"However, by dampening down the immune system, these drugs increase the risk of certain serious infections and also prevent some vaccines working well.

“Because Covid-19 is caused by a new virus, we don’t yet know if these drugs increase the risk or severity of infection.

"As a precaution the UK government advised many patients treated with these medicines to ‘shield’ themselves during the 12-week lockdown in March.

"Although these measures reduced transmission of the virus, they caused isolation and anxiety for many patients, disrupted medical and social care, threatened education and employment, and for society had a significant economic impact.”

The outcomes of patients in the study will be looked at over the next 12 months, and could impact the millions of people across the UK who live with other immune mediated diseases, like arthritis, which are treated with similar therapies.

Ahmad added: "We will collect information directly from patients about symptoms, tests, hospitalisations and physical distancing behaviour related to Covid-19 and link this to other data already held by other health organisations.

"Using an antibody test, we will follow antibody responses to the virus over a 40-week period.”

Researchers at participating hospitals will be approaching volunteers over the next three months, and Crohn’s & Colitis UK will be recruiting the Patient Advisory Group to make sure the voices of people living with IBD are at the centre of the study.

They will be asked to complete a questionnaire every eight weeks and donate a blood sample at infusion visits; results of the antibody test will be made available to participants.

Tony Berry, chairman of the local IBD Group, member of the Study Management Group and Patient Participation Involvement and Engagement Group, said: “The CLARITY research study is a very important to those of us who are on immunosuppressant and biologic drugs because, at present, there is very little known about the possible increased risk to Crohn’s and colitis patients on these treatments if they were to contract Covid-19.

"Patients are also concerned about the increased risk of catching Covid-19, the possible increase in risk of life-threatening complications if they became infected, and if future vaccines will be as effective if an IBD patient is on immunosuppressant treatments.

"Hopefully, the CLARITY study will help answer some of the IBD patients’ concerns and help inform policy decisions in the future.”

Anyone interested in being involved in the study, or wanting more information, should email rde-tr.clarityibd@nhs.net, visit the study website here or follow @CLARITYIBD on Twitter for updates.