The author's goal is to review recent phase III clinical trials in patients with systemic lupus erythematosus (SLE), with emphasis on outcomes and on mechanisms by which the experimental drugs/biological agents suppress autoimmunity.
Prospective, randomised, controlled clinical trials in SLE published in the past 3 years identified in a PubMed search were reviewed, as well as abstracts describing similar but currently unpublished clinical trials presented at international meetings 2008-10.
Two interventions have been proved in large multicentre prospective trials to be useful in the management of SLE: mycophenolate mofetil (equivalent to cyclophosphamide with a similar safety profile) and anti-BLyS (Benlysta), which was superior to placebo when added to background immunosuppression and did not appear to increase toxicity. The anti-BLyS trial outcome measure was an anchored composite index that required reduction of disease activity measure by the systemic lupus erythematosus disease activity index. Other trials that failed or the results of which are pending are also discussed.