About the FIRST trial
FIrst-line Rituximab in Systemic lupus erythematosus Trial
What is the FIRST trial?
SLE is a life-long autoimmune disease that causes inflammation and damage to a range of organs. It is more severe in children and people of non-European ancestries. Current practice is to treat SLE with a series of conventional immunosuppressants combined with glucocorticoids (GC), but evidence for the sequence in which they should be used is weak.
Under current guidelines, if this approach fails, and people have moderate to severe SLE, a more effective therapy, rituximab (RTX), can be added to these agents later as usual care. This approach may not be optimal since SLE is most severe within the first 12 months of diagnosis, with the highest mortality, GC exposure and healthcare resource use.
The FIRST trial is a multicentre, double-blind, randomised, placebo-controlled, superiority trial with an internal pilot and cost effectiveness analysis to determine if early treatment with rituximab in moderate/severe lupus is superior to usual care.
Target Population
We aim to recruit 128 in-patients and out-patients aged 5 years or older, with a recent SLE diagnosis, moderate to severe disease activity, from rheumatology, renal and dermatology clinics.
Design
2-arm, double-blind, randomised (1:1):
• Arm 1 (64 patients) – IV rituximab + usual care
• Arm 2 (64 patients) – IV placebo + usual care
Participants will be followed monthly for 12 months to assess disease activity, side effects, health-related quality of life and requirements of steroids or other new therapy to treat SLE. Healthcare costs will also be calculated.
Primary Outcome
Cumulative time where SLE disease activity is adequately controlled on an acceptable GC dose, defined by the Low-Level Disease Activity Score (LLDAS).