Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT:

Introduction

We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar^® 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 ≥ 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 ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Stable glucocorticoid doses were 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. Endpoin

SUBMITTER: Askanase AD 

PROVIDER: S-EPMC7695765 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature