Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multice
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ORIGINAL RESEARCH
Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, DoubleBlind, Placebo-Controlled Trial Anca D. Askanase . Enxu Zhao . Julie Zhu . Roman Bilyk . Richard A. Furie
Received: July 30, 2020 / Accepted: September 14, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: We assessed the efficacy and safety of repository corticotropin injection (RCI; ActharÒ Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids. Methods: This multicenter, double-blind, randomized, placebo-controlled study enrolled patients C 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5–30 mg/day prednisone equivalent) and antimalarials for C 4 weeks and/or immunosuppressants for C 8 weeks before screening. Stable glucocorticoid doses were Digital Features This article is published with digital features to facilitate understanding of the article. To view digital features for this article go to https://doi.org/ 10.6084/m9.figshare.12951239. Electronic Supplementary Material The online version of this article (https://doi.org/10.1007/s40744020-00236-1) contains supplementary material, which is available to authorized users. A. D. Askanase (&) Columbia University Medical Center, New York, NY, USA e-mail: [email protected] E. Zhao J. Zhu R. Bilyk Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA R. A. Furie Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA
required through week 16 with optional taper from weeks 16 to 24. Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24. Endpoints included the proportion of SLE Responder Index (SRI)-4 responders at week 16; changes from baseline to week 16 in 28 Swollen Joint Count/ Tender Joint Count (28 SJC/TJC) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity score; and changes from baseline to week 24 in inflammatory cytokines. Safety was assessed by adverse events. Results: In the modified intention-to-treat population (RCI, n = 84; placebo, n = 85), the proportion of SRI-4 responders at week 16 was not significantly different between groups (RCI, 47.6%; placebo, 43.5%; OR [95% CI] 1.2 [0.6 to 2.2]; p = 0.5762). RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine. Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 C 10 and CLASI-Activity C 11. No new safety signals were identified. Conclusions: Despite failure to achieve the primary endpoint, these results support the utility of RCI for treating persistently active SLE. Trial Registration: ClinicalTrials.go
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