A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

Summary

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

Timeline

Start

2012-01

Primary completion

2015-04

Completion

2015-04

Outcome

Met primary endpoint

registry Placebo vs Anifrolumab 300 mg; p = 0.014; Odds Ratio (OR) 2.38 (90% CI 1.33 to 4.26); Regression, Logistic NCT01438489 ↗

paper The primary end point was met by more patients treated with anifrolumab PMID 28130918 ↗

registry Placebo vs Anifrolumab 300 mg; p = 0.004; Odds Ratio (OR) 3.55 (90% CI 1.72 to 7.32); Regression, Logistic NCT01438489 ↗

Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
• Casey KA, Smith MA, Sinibaldi D, Seto NL, Playford MP, Wang X, Carlucci PM, Wang L, Illei G, Yu B, Wang S, Remaley AT, Mehta NN, Kaplan MJ, White WI. Modulation of Cardiometabolic Disease Markers by Type I Interferon Inhibition in Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Mar;73(3):459-471. doi: 10.1002/art.41518. Epub 2021 Feb 15.
• Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
• Casey KA, Guo X, Smith MA, Wang S, Sinibaldi D, Sanjuan MA, Wang L, Illei GG, White WI. Type I interferon receptor blockade with anifrolumab corrects innate and adaptive immune perturbations of SLE. Lupus Sci Med. 2018 Nov 22;5(1):e000286. doi: 10.1136/lupus-2018-000286. eCollection 2018.
• Morand EF, Trasieva T, Berglind A, Illei GG, Tummala R. Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. Ann Rheum Dis. 2018 May;77(5):706-713. doi: 10.1136/annrheumdis-2017-212504. Epub 2018 Feb 2.
• Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, Illei GG, Drappa J, Wang L, Yoo S; CD1013 Study Investigators. Anifrolumab, an Anti-Interferon-alpha Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anifrolumab	Monoclonal antibody	300 mg	Intravenous
Subject	Anifrolumab	Monoclonal antibody	1000 mg	Intravenous

Indications