27 September 2021

During, and after, treatment for a heart attack, the heart muscle can become very inflamed due to the ischaemia (lack of blood flow) and reperfusion (restoring blood flow). There is strong evidence to show that the inflammation is mediated by the immune system (blood cells that fight infection) and can lead to long lasting heart damage. The RITA MI trial, sponsored by Royal Papworth Hospital and run by the Clinical Trials Unit, was interested in temporarily decreasing this immune response with medication (RITUXIMAB) and preventing this inflammation. The immune system should completely revert back to normal after the medication is given. Although RITUXIMAB has been safely administered in people for disease like Rheumatoid Arthritis, it had not been used in heart disease. But recent research showed that it may be useful in treating inflammation and therefore preventing future heart failure after a heart attack.

24 patients were recruited to the trial in total. Four escalating doses of Rituximab (200, 500, 700, and 1000 mg) were used and there were 6 patients per group. The primary end point was safety of the drug, whilst the secondary end points were looking at changes in circulating immune cell subsets including B cells, and cardiac and inflammatory biomarkers. 

In this first RITA-MI trial, we have shown promising safety and feasibility data for the use of a single infusion of rituximab in patients with ST elevated myocardial infarction (STEMI). In addition, we provided important new insights into the feasibility and pharmacodynamics of rituximab and novel immunological insights have been gained into its effects in patients.  The data from this first trial has provided the pilot data for a successful EU grant application to conduct a multi-national randomised controlled trail using a single dose of Rituximab to assess efficacy, which will begin later this year.  Royal Papworth and the Clinical Trials Unit will act as UK sponsor representative for this trial and Dr Hoole will be the UK based Chief Investigator. 

To read the RITA MI publication click here.