Update on Clinical Trials in Systemic Lupus Erythematosus

Sonali Narain; Richard Furie


Curr Opin Rheumatol. 2016;28(5):477-487. 

In This Article

Immunoregulatory Peptides

Edratide (hCDR1) is a peptide[42] that down-regulates interleukin-1β (IL-1β), interferonγ (IFNγ) and IL-10 and up-regulates Transforming Growth Factor-β. It reduces the production of BLyS leading to a decrease in antidsDNA antibody production. Study results of subcutaneous edratide (0.5, 1 and 2.5 mg) were published in 2015.[43] Although the study failed to meet its primary end points of reduction in SLE Disease Activity Index (SLEDAI)-2K and Adjusted Mean SLEDAI, further analysis demonstrated a statistically significant difference (P = 0.03) between the 0.5 mg edratide arm (n = 76) and the placebo arm (n = 83) using BILAG response.

Rigerimod is a P140 peptide derived from spliceosomal small nuclear ribonucleoprotein U-170k that inhibits T-cell reactivity with Major histocompatibility complex-presented self-peptides. The open-label phase II study[44] noted a decrease in antidsDNA antibody levels in patients receiving the 200 mcg dose as well as an improvement in SLEDAI score. The second study[45] had enrolled 149 patients when an interim analysis in 114 patients demonstrated a significant at least four-point reduction in clinical SLEDAI from baseline in the 200 mcg q4W arm at weeks 12 and 24 but not with 200 mcg q2W. When analyzed as intention to treat at week 24, the pooled data failed to confirm these results.[44,45]