Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus

Lupus Science and Medicine

Volumn 5, Issue 1, 2018, Pages

  Riggs, Jeffrey M ^a   Hanna, Richard N ^a   Rajan, Bhargavi ^a   Zerrouki, Kamelia ^a   Karnell, Jodi L ^a   Sagar, Divya ^a   Vainshtein, Inna ^a   Farmer, Erika ^a   Rosenthal, Kimberly ^a   Morehouse, Chris ^a   De Los Reyes, Melissa ^a   Schifferli, Kevin ^a   Liang, Meina ^a   Sanjuan, Miguel A ^a   Sims, Gary P ^a   Kolbeck, Roland ^a  

^a MEDIMMUNE   (United States)

Author keywords

cytokines; dmards (biologic); interferon; systemic lupus erythematosus; treatment

Indexed keywords

ALPHA INTERFERON RECEPTOR; ANIFROLUMAB; STAT1 PROTEIN;

ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ARTICLE; CELL DIFFERENTIATION; COMPLEMENT DEPENDENT CYTOTOXICITY; CONFOCAL MICROSCOPY; CONTROLLED STUDY; CYTOKINE PRODUCTION; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; FLOW CYTOMETRY; HUMAN; INTRACELLULAR SIGNALING; OUTCOME ASSESSMENT; PLASMACYTOID DENDRITIC CELL; PRIORITY JOURNAL; PROTEIN EXPRESSION; PROTEIN PHOSPHORYLATION; SYSTEMIC LUPUS ERYTHEMATOSUS;

EID: 85048103836     PISSN: None     EISSN: 20538790     Source Type: Journal    
DOI: 10.1136/lupus-2018-000261     Document Type: Article

References (45)

1. Tsokos GC. Systemic lupus erythematosus. N Engl J Med 2011;365:2110-21.
2. Lam NC, Ghetu MV, Bieniek ML. Systemic lupus erythematosus: primary care approach to diagnosis and management. Am Fam Physician 2016;94:284-94.
3. Lisnevskaia L, Murphy G, Isenberg D. Systemic lupus erythematosus. The Lancet 2014;384:1878-88.
4. Tsokos GC, Lo MS, Costa Reis P, Ms L, Reis PC, et al. New insights into the immunopathogenesis of systemic lupus erythematosus. Nat Rev Rheumatol 2016;12:716-30.
5. Weckerle CE, Franek BS, Kelly JA, et al. Network analysis of associations between serum interferon-α activity, autoantibodies, and clinical features in systemic lupus erythematosus. Arthritis Rheum 2011;63:1044-53.
6. Kirou KA, Lee C, George S, et al. Activation of the interferon-alpha pathway identifies a subgroup of systemic lupus erythematosus patients with distinct serologic features and active disease. Arthritis Rheum 2005;52:1491-503.
7. Panda SK, Kolbeck R, Sanjuan MA. Plasmacytoid dendritic cells in autoimmunity. Curr Opin Immunol 2017;44:20-5.
8. Lövgren T, Eloranta ML, Båve U, et al. Induction of interferon-alpha production in plasmacytoid dendritic cells by immune complexes containing nucleic acid released by necrotic or late apoptotic cells and lupus IgG. Arthritis Rheum 2004;50:1861-72.
9. Rowland SL, Riggs JM, Gilfillan S, et al. Early, transient depletion of plasmacytoid dendritic cells ameliorates autoimmunity in a lupus model. J Exp Med 2014;211:1977-91.
10. Sisirak V, Ganguly D, Lewis KL, et al. Genetic evidence for the role of plasmacytoid dendritic cells in systemic lupus erythematosus. J Exp Med 2014;211:1969-76.
11. Ah Kioon MD, Tripodo C, Fernandez D, et al. Plasmacytoid dendritic cells promote systemic sclerosis with a key role for TLR8. Sci Transl Med 2018;10:eaam8458.
12. Hall JC, Rosen A. Type I interferons: crucial participants in disease amplification in autoimmunity. Nat Rev Rheumatol 2010;6:40-9.
13. Ivashkiv LB, Donlin LT. Regulation of type I interferon responses. Nat Rev Immunol 2014;14:36-49.
14. Hooks JJ, Moutsopoulos HM, Geis SA, et al. Immune interferon in the circulation of patients with autoimmune disease. N Engl J Med 1979;301:5-8.
15. Deng Y, Tsao BP. Advances in lupus genetics and epigenetics. Curr Opin Rheumatol 2014;26:482-92.
16. Postal M, Sinicato NA, Peliçari KO, et al. Clinical and serological manifestations associated with interferon-α levels in childhood-onset systemic lupus erythematosus. Clinics 2012;67:157-62.
17. Dall'era MC, Cardarelli PM, Preston BT, et al. Type I interferon correlates with serological and clinical manifestations of SLE. Ann Rheum Dis 2005;64:1692-7.
18. Ioannou Y, Isenberg DA. Current evidence for the induction of autoimmune rheumatic manifestations by cytokine therapy. Arthritis Rheum 2000;43:1431-42.
19. Kim JM, Park SH, Kim HY, et al. A plasmacytoid dendritic cells-type I interferon axis is critically implicated in the pathogenesis of systemic lupus erythematosus. Int J Mol Sci 2015;16:14158-70.
20. Goropevšek A, Holcar M, Avčin T. The role of STAT signaling pathways in the pathogenesis of systemic lupus erythematosus. Clin Rev Allergy Immunol 2017;52:164-81.
21. Sozzani S, Bosisio D, Scarsi M, et al. Type I interferons in systemic autoimmunity. Autoimmunity 2010;43:196-203.
22. Crow MK, Olferiev M, Kirou KA. Targeting of type I interferon in systemic autoimmune diseases. Transl Res 2015;165:296-305.
23. Kessler DS, Levy DE, Darnell JE. Two interferon-induced nuclear factors bind a single promoter element in interferon-stimulated genes. Proc Natl Acad Sci U S A 1988;85:8521-5.
24. Levy DE, Kessler DS, Pine R, et al. Interferon-induced nuclear factors that bind a shared promoter element correlate with positive and negative transcriptional control. Genes Dev 1988;2:383-93.
25. Kim S, Kaiser V, Beier E, et al. Self-priming determines high type I IFN production by plasmacytoid dendritic cells. Eur J Immunol 2014;44:807-18.
26. Liao AP, Salajegheh M, Morehouse C, et al. Human plasmacytoid dendritic cell accumulation amplifies their type 1 interferon production. Clin Immunol 2010;136:130-8.
27. Peng L, Oganesyan V, Wu H, et al. Molecular basis for antagonistic activity of anifrolumab, an anti-interferon-α receptor 1 antibody. MAbs 2015;7:428-39.
28. Oganesyan V, Gao C, Shirinian L, et al. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr 2008;64:700-4.
29. Henault J, Martinez J, Riggs JM, et al. Noncanonical autophagy is required for type I interferon secretion in response to DNA-immune complexes. Immunity 2012;37:986-97.
30. Yao Y, Richman L, Higgs BW, et al. Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum 2009;60:1785-96.
31. Pogue SL, Preston BT, Stalder J, et al. The receptor for type I IFNs is highly expressed on peripheral blood B cells and monocytes and mediates a distinct profile of differentiation and activation of these cells. J Interferon Cytokine Res 2004;24:131-9.
32. Rönnblom L, Eloranta ML. The interferon signature in autoimmune diseases. Curr Opin Rheumatol 2013;25:248-53.
33. Wang B, Higgs BW, Chang L, et al. Pharmacogenomics and translational simulations to bridge indications for an anti-interferon-α receptor antibody. Clin Pharmacol Ther 2013;93:483-92.
34. Platanias LC. Mechanisms of type-I- and type-II-interferon-mediated signalling. Nat Rev Immunol 2005;5:375-86.
35. Ytterberg SR, Schnitzer TJ. Serum interferon levels in patients with systemic lupus erythematosus. Arthritis Rheum 1982;25:401-6.
36. Rodero MP, Decalf J, Bondet V, et al. Detection of interferon alpha protein reveals differential levels and cellular sources in disease. J Exp Med 2017;214:1547-55.
37. Swiecki M, Colonna M. The multifaceted biology of plasmacytoid dendritic cells. Nat Rev Immunol 2015;15:471-85.
38. Hueber W, Zeng D, Strober S, et al. Interferon-alpha-inducible proteins are novel autoantigens in murine lupus. Arthritis Rheum 2004;50:3239-49.
39. Strandberg L, Ambrosi A, Espinosa A, et al. Interferon-alpha induces up-regulation and nuclear translocation of the Ro52 autoantigen as detected by a panel of novel Ro52-specific monoclonal antibodies. J Clin Immunol 2008;28:220-31.
40. Jego G, Palucka AK, Blanck JP, et al. Plasmacytoid dendritic cells induce plasma cell differentiation through type I interferon and interleukin 6. Immunity 2003;19:225-34.
41. Le Bon A, Schiavoni G, D'Agostino G, et al. Type I interferons potently enhance humoral immunity and can promote isotype switching by stimulating dendritic cells in vivo. Immunity 2001;14:461-70.
42. Avalos AM, Busconi L, Marshak-Rothstein A. Regulation of autoreactive B cell responses to endogenous TLR ligands. Autoimmunity 2010;43:76-83.
43. Das A, Heesters BA, Bialas A, et al. Follicular dendritic cell activation by tlr ligands promotes autoreactive B cell responses. Immunity 2017;46:106-19.
44. Goldberg A, Geppert T, Schiopu E, et al. Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study. Arthritis Res Ther 2014;16:R57.
45. Furie R, Khamashta M, Merrill JT, et al. Anifrolumab, an antiinterferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol 2017;69:376-86.