LAUSR

We note with interest and express our principle agreement with the views put forward by Professor Frederic Houssiau in the recent Editorial ‘Time to change the primary outcome of lupus trials’ published in Annals of the Rheumatic Diseases .1 Professor Houssiau advocated using steroid reduction as a primary outcome measure in systemic lupus erythematosus (SLE) clinical trials, or as a minimum, incorporating a steroid reduction target into the primary endpoint. This proposal was prompted by the observation that, like many other recent phase 3 clinical trials conducted with drugs that have a sound biological mechanism for benefit in SLE, the recently published CHABLIS-SC phase 3 clinical trial of subcutaneous blisibimod in SLE2 failed to meet its primary endpoint of a week 52-SLE Responder Index (SRI)-6. However, a significant steroid sparing effect was seen, with a modified endpoint of a week 52-SRI-6 combined with a reduction in steroid dose during weeks 40–52 compared with study entry, showing a trend to benefit for the blisibimod …