Why carry out this study?

Repository corticotropin injection (RCI; Acthar® Gel) is currently approved for use during exacerbations and as maintenance therapy for systemic lupus erythematosus (SLE).

Findings from a prospective phase 4 study and subsequent post hoc analyses suggested that RCI is safe and may be effective for treating patients who have persistently active SLE despite treatment with moderate-dose glucocorticoids.

These results provided the basis for further evaluation in this larger, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of RCI for the treatment of persistently active SLE.

What was learned from the study?

Treatment with RCI was associated with improvements of several clinical and pharmacodynamic endpoints: 28 Swollen Joint Count/Tender Joint Count, Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-Activity) scores, and levels of B-cell activating factor cytokine. Post hoc analyses demonstrated a greater proportion of British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) responders for RCI than for placebo and greater SLE Responder Index (SRI)-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥10, CLASI-Activity ≥11, British Isles Lupus Assessment Group-2004 ≥20, and complement component 4 <17 mg/dl than in patients with lower disease activity.

The favorable BICLA response observed with RCI for the entire population in combination with benefits seen with SRI-4 in patients with high levels of baseline disease activity support the value of RCI for the treatment of persistently active SLE despite background glucocorticoids.