Clinical trials of novel therapeutics in systemic lupus erythematosus (SLE) have so far been disappointing. A high placebo response rate in these trials owing to continued use of background immunosuppressive therapy could be confounding results. Could patient stratification and minimization of entry medications improve the effect size and interpretability of SLE trials?
Refers to Merrill, J. T. et al. The Biomarkers Of Lupus Disease study: a bold approach may mitigate interference of background immunosuppressants in clinical trials. Arthritis Rheumatol. Dis.http://dx.doi.org/10.1002/art.40086 (2017)