Manchester researchers successfully awarded £1.8m grant to help identify effective steroid use for patients with Rheumatoid Arthritis
Researchers from the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC) have been successfully awarded a Health Technology Assessment (HTA) grant for £1.8 million to potentially identify the most effective and safest way of using steroids for patients with uncontrolled Rheumatoid Arthritis who are starting an anti-rheumatic medicine.
Rheumatoid Arthritis (RA) causes joint pain and swelling affecting people’s day to day activities and quality of life and patients are currently offered steroids which act quickly to control symptoms whilst waiting for anti-rheumatic medicines to take effect.
Steroids can have long-term side effects such as diabetes, weight gain and skin changes and can be given as an injection into the muscle or as a daily tablet.
Dr James Bluett, researcher in the NIHR Manchester BRC’s Rheumatic and Musculoskeletal Diseases (RMD) Theme and Honorary Senior Clinical Lecturer at Manchester University NHS Foundation Trust (MFT) was lead applicant for the HTA grant from NIHR, along with Professor Anne Barton, RMD Co-Theme Lead. Prof Barton has recently been appointed as the new Director of the NIHR Manchester BRC and will take up the role from 1 April 2024.
Dr Bluett said; “We currently do not know whether steroids should be given as tablets or an injection and what dose has the best balance between side effects and rapid symptom relief.
“Patients living with RA who are starting an anti-rheumatic medicine will be invited to take part in the LEADER study. The aim of this study is to try to identify the most effective and safest way of using steroids for patients with uncontrolled RA who are starting an anti-rheumatic medicine.
“The study will assess whether an injection or daily tablet is better at controlling the disease whilst remaining cost-effective. Two dose levels will be tested to see which has the best balance between disease control and side effects.”
The grant will enable researchers to run a multi-centre randomised clinical trial aimed at assessing whether an injection or daily tablet is better at controlling the disease whilst remaining cost-effective.
Patients will be identified from general rheumatology clinics. The study will compare how active a person’s RA is, between tablets and injection, and also dose levels, to assess which treatment could be most effective.
Alongside this, the study will consider if the treatment has improved other symptoms such as fatigue, ability to undertake day-to-day activities, ability to work, quality of life and if it reduces the amount of pain killers used. Side effects such as weight gain and mood changes will also be monitored.
Patients will be assessed regularly during the first 3 months and at 6 months to see if the treatment has given them a continued improvement in their RA symptoms.
Two people living with RA will also be co-investigators in the LEADER trial. Kate Wilkins, who lives in Wales and was diagnosed in 2005, said:
As a person diagnosed with RA, I believe the LEADER trial is of great importance and value. It could have the potential to change a patient’s often debilitating symptoms of RA in the most targeted and effective way, which will be of benefit to all.
Karen Staniland (pictured) added; “I have had rheumatoid arthritis for 12 years and, for the first 2 years, was treated by steroids with varying results. I am therefore pleased to be involved in this important research as one of the patient partners. I believe that the LEADER study could make a real difference to patients’ lives and help provide some answers in the effective and safe use of steroids, which in turn, could help improve quality of life.”
The grant is in collaboration with colleagues from King’s College Hospital, University College London, Queen’s University Belfast, University of Oxford, The University of Manchester, with MFT as the host organisation.
The RMD Theme is part of Manchester BRC’s Inflammation Cluster along with 3 other research Themes; Respiratory Medicine, Dermatology and Integrative Cardiovascular Medicine.
These conditions – which include arthritis and related conditions, chest diseases, skin disorders and heart disease – are all underpinned by chronic inflammation.
Watch the BRC’s Spotlight On film here to find out how Manchester BRC’s inclusive and proactive research, presented by Prof Barton, is driving health improvements in rheumatic and musculoskeletal diseases and other health conditions.