Can I read Abstracts - 210 Integrated safety profile of atacicept from all clinical studies to date on EtoBox?

Abstracts - 210 Integrated safety profile of atacicept from all clinical studies to date by Gordon, Caroline; Bassi, Roberto; Chang, Peter; H Kao, Amy; Jayne, David; Wofsy, David; Ona, Victor; Fleuranceau-Morel, Patricia is a scholarly article available to read on EtoBox.

What is Abstracts - 210 Integrated safety profile of atacicept from all clinical studies to date about?

Background Low disease activity (LDA) and remission are important goals in the treatment of patients with SLE. 1 2 Lupus Low Disease Activity State (LLDAS) is associated with reduced damage accrual, 2 and has been shown to be a feasible clinical trial endpoint. 3 In patients with high disease activity (HDA; SLEDAI-2K ≥10) enrolled in the ADDRESS II study, atacicept improved SLE responder index (SRI)-6 response rates and flare prevention at Week 24 vs placebo. Atacicept also demonstrated an acceptable safety profile. 4 We present a posthoc analysis of data from ADDRESS II and its long-term extension, describing 48-week LDA and remission rates in patients with HDA at Screening. Methods In ADDRESS II, patients were randomized (1:1:1) to weekly subcutaneous atacicept 75 or 150 mg or placebo for 24 weeks. Atacicept-completers continued at the same dose in the extension study, while placebo-treated patients were switched to atacicept 150 mg (placebo/atacicept 150 mg). This post-hoc analysis assessed: LDA (SLEDAI-2K ≤2), LLDAS (SLEDAI-2K ≤4 without major organ activity, no new disease activity vs previous visit, Physician's Global Assessment [PGA] ≤1, prednisone-equivalent ≤7.5 mg/day, an

Author

Gordon, Caroline; Bassi, Roberto; Chang, Peter; H Kao, Amy; Jayne, David; Wofsy, David; Ona, Victor; Fleuranceau-Morel, Patricia

Publisher

Lupus Foundation of America

Published

2019

Language

EN