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Richard Furie, … , Dania Rabah, Nathalie Franchimont
Published January 15, 2019
Citation Information: J Clin Invest. 2019;129(3):1359-1371. https://doi.org/10.1172/JCI124466.
Citation Information: J Clin Invest. 2019;129(3):1359-1371. https://doi.org/10.1172/JCI124466.
Abstract
BACKGROUND. Plasmacytoid DCs (pDC) produce large amounts of type I IFN (IFN-I), cytokines convincingly linked to systemic lupus erythematosus (SLE) pathogenesis. BIIB059 is a humanized mAb that binds blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. A first-in-human study was conducted to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single BIIB059 doses in healthy volunteers (HV) and patients with SLE with active cutaneous disease as well as proof of biological activity and preliminary clinical response in the SLE cohort. METHODS. A randomized, double-blind, placebo-controlled clinical trial was conducted in HV (n = 54) and patients with SLE (n = 12). All subjects were monitored for adverse events. Serum BIIB059 concentrations, BDCA2 levels on pDCs, and IFN-responsive biomarkers in whole blood and skin biopsies were measured. Skin disease activity was determined using the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A). RESULTS. Single doses of BIIB059 were associated with favorable safety and PK profiles. BIIB059 administration led to BDCA2 internalization on pDCs, which correlated with circulating BIIB059 levels. BIIB059 administration in patients with SLE decreased expression of IFN response genes in blood, normalized MxA expression, reduced immune infiltrates in skin lesions, and decreased CLASI-A score. CONCLUSIONS. Single doses of BIIB059 were associated with favorable safety and PK/PD profiles and robust target engagement and biological activity, supporting further development of BIIB059 in SLE. The data suggest that targeting pDCs may be beneficial for patients with SLE, especially those with cutaneous manifestations. TRIAL REGISTRATION. ClinicalTrials.gov NCT02106897. FUNDING. Biogen Inc.
Authors
Richard Furie, Victoria P. Werth, Joseph F. Merola, Lauren Stevenson, Taylor L. Reynolds, Himanshu Naik, Wenting Wang, Romy Christmann, Agnes Gardet, Alex Pellerin, Stefan Hamann, Pavan Auluck, Catherine Barbey, Parul Gulati, Dania Rabah, Nathalie Franchimont
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Journal of Clinical Investigation | 2019 |
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A pathogenic role of plasmacytoid dendritic cells in autoimmunity and chronic viral infection
FJ Barrat, L Su |
Journal of Experimental Medicine | 2019 |
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The Role of Immune Checkpoint Receptors in Regulating Immune Reactivity in Lupus
KL Lu, MY Wu, CH Wang, CW Wang, SI Hung, WH Chung, CB Chen |
Cells | 2019 |
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Interferon pathway in SLE: one key to unlocking the mystery of the disease
L Rönnblom, D Leonard |
Lupus Science & Medicine | 2019 |
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Effect of in vivo Hydroxychloroquine and ex vivo Anti-BDCA2 mAb Treatment on pDC IFNα Production From Patients Affected With Cutaneous Lupus Erythematosus
A Gardet, A Pellerin, CA McCarl, R Diwanji, W Wang, D Donaldson, N Franchimont, VP Werth, D Rabah |
Frontiers in immunology | 2019 |
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Role of type I interferons and innate immunity in systemic sclerosis: unbalanced activities on distinct cell types?
FJ Barrat, TT Lu |
Current Opinion in Rheumatology | 2019 |
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Docosahexaenoic Acid Consumption Impedes Early Interferon- and Chemokine-Related Gene Expression While Suppressing Silica-Triggered Flaring of Murine Lupus
AD Benninghoff, MA Bates, PS Chauhan, KA Wierenga, KN Gilley, A Holian, JR Harkema, JJ Pestka |
Frontiers in immunology | 2019 |
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Interferon target-gene expression and epigenomic signatures in health and disease
FJ Barrat, MK Crow, LB Ivashkiv |
Nature Immunology | 2019 |
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Type I interferons in host defence and inflammatory diseases
MK Crow, L Ronnblom |
Lupus Science & Medicine | 2019 |
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Current Paradigms of Tolerogenic Dendritic Cells and Clinical Implications for Systemic Lupus Erythematosus
Ritprajak, Kaewraemruaen, Hirankarn |
Cells | 2019 |
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Re-evaluation of human BDCA-2+ DC during acute sterile skin inflammation
YL Chen, T Gomes, CS Hardman, FA Braga, D Gutowska-Owsiak, M Salimi, N Gray, DA Duncan, G Reynolds, D Johnson, M Salio, V Cerundolo, JL Barlow, AN McKenzie, SA Teichmann, M Haniffa, G Ogg |
Journal of Experimental Medicine | 2019 |
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Advancing understanding, diagnosis, and therapies for cutaneous lupus erythematosus within the broader context of systemic lupus erythematosus
KL Chen, RL Krain, VP Werth |
F1000Research | 2019 |
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Current Concepts and Future Approaches in the Treatment of Cutaneous Lupus Erythematosus: A Comprehensive Review
F Chasset, C Francès |
Drugs | 2019 |
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Pulmonary surfactant: an immunological perspective
ZC Chroneos, Z Sever-Chroneos, VL Shepherd |
Cellular physiology and biochemistry : international journal of experimental cellular physiology, biochemistry, and pharmacology | 2009 |
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