The PERSONAL-SLE Study
Research type
Research Study
Full title
Precision medicine to predict response to B cell depletion therapy in lupus (PERSONAL) Study
IRAS ID
328365
Contact name
Chris Wincup
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Systemic lupus erythematosus (SLE) is a chronic, incurable autoimmune condition that can present with a number of symptoms including joint pain (arthralgia/arthritis), kidney inflammation (termed lupus nephritis, which affects 50% of patients and can lead to kidney failure requiring dialysis or kidney transplantation), rashes and abnormalities within the blood (including low blood counts and the production of different autoantibodies).
Severe forms of the disease are common. In such cases, rituximab (an antibody therapy that removes the B cells that drive the disease) is licensed for use in the UK. However, this treatment is not effective for all patients and it is difficult to predict who will respond to this therapy. It is possible to measure the number of B cells in blood and this is done as part of routine clinical care. Following treatment we expect the number of B cells in the blood to reduce to zero. However, in some cases the B cell numbers in the blood do not deplete following treatment and as such the treatment is ineffective. Furthermore, even when the B cell count in blood does deplete to zero this does not guarantee the treatment will be effective.
We suggest that measuring the B cells in blood only tells some of the story and instead we should focus on what these cells are doing in the affected tissue (predominantly kidney, skin, joint and bone marrow).
In this study we will examine both blood and tissue prior to treatment with rituximab, and in the event of a lack of response to treatment we will resample the tissue to see if impaired efficacy of treatment with rituximab is due to either failure to reduce B cells within tissue, or if B cells are not the main driver of the disease in the first place.
REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0062
Date of REC Opinion
23 Feb 2024
REC opinion
Further Information Favourable Opinion