1 November 2018
Safety and Efficacy of Belimumab after B cell Depletion Therapy in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE) is chronic autoimmune disease that occurs when a person's antibodies, produced by immune B cells, attack the body's own cells.
This attack causes severe inflammation, with a range of problems including fatigue, rashes, hair loss, arthritis, kidney involvement and blood disorders. Long-term complications in SLE can include early onset heart attacks, strokes and kidney failure. There are limited treatments for patients with SLE, however biologic therapies in lupus have shown some promise but have yet to make a substantial impact upon this disease.
BEAT Lupus is a UK Phase II multicentre randomised, double blind, placebo-controlled clinical trial investigating the safety and efficacy of Belimumab starting 4-8 weeks after the first cycle of B cell depletion therapy (Rituximab). We propose to recruit 50 SLE patients and randomise 25 patients to receive Belimumab and 25 patients to receive placebo following standard of care (Rituximab).
As this combination of B cell targeting agents given in quick succession has not been reported in humans, BEAT Lupus is as an early phase clinical trial designed to assess the safety and effectiveness of this treatment regime for patients with lupus, as judged by change in anti dsDNA antibody levels.
The trial is funded by Arthritis Research UK, GlaxoSmithKline and UCLH Biomedical Research Centre and is in the set up / early recruitment phase with a total of 15 sites to be opened in the UK.
Recruitment and followups have now concluded, and the trial has officially closed.
- Muller P, Chowdhury K, Gordon C, Ehrenstein MR, Doré CJ. Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan. Trials 2020;21, 652. https://doi.org/10.1186/s13063-020-04391-2
- Alexis Jones, Patrick Muller, Caroline J Dore, Felicia Ikeji, Emilia Caverly, Kashfia Chowdhury, David A Isenberg, Caroline Gordon, Michael R Ehrenstein (2019). Belimumab after B cell depletion therapy in patients with systemic lupus erythematosus (BEAT Lupus) protocol: a prospective multicentre, double-blind, randomised, placebo-controlled, 52-week phase II clinical trial. BMJ.