RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 α1 and α2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study

[1]  A. Schoepfer,et al.  A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ANTI-INTERLEUKIN-13 MONOCLONAL ANTIBODY RPC4046 IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS , 2018, Annals of Allergy, Asthma & Immunology.

[2]  R. Terracciano,et al.  Dupilumab for the treatment of asthma , 2017, Expert opinion on biological therapy.

[3]  J. Breed,et al.  Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. , 2017, Journal of molecular biology.

[4]  E. Bateman,et al.  Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. , 2016, The Lancet. Respiratory medicine.

[5]  E. R. Sutherland,et al.  Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial , 2016, The Lancet.

[6]  T. Wyant,et al.  Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance , 2016, Journal of immunology research.

[7]  A. Heatherington,et al.  A mechanistic PK/PD model for two anti-IL13 antibodies explains the difference in total IL-13 accumulation observed in clinical studies , 2016, mAbs.

[8]  P. O'Byrne,et al.  Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. , 2015, The Lancet. Respiratory medicine.

[9]  R. Maciuca,et al.  Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies , 2015, Thorax.

[10]  P. Korenblat,et al.  Anti-interleukin 4 and 13 for asthma treatment in the era of endotypes , 2014, Current opinion in allergy and clinical immunology.

[11]  A. Vatrella,et al.  Dupilumab: a novel treatment for asthma , 2014, Journal of asthma and allergy.

[12]  J. Corren.  Role of Interleukin-13 in Asthma , 2013, Current Allergy and Asthma Reports.

[13]  M. Ultsch,et al.  Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. , 2013, Journal of molecular biology.

[14]  S. Spechler,et al.  Tissue remodeling in eosinophilic esophagitis. , 2012, American journal of physiology. Gastrointestinal and liver physiology.

[15]  Monica Kraft,et al.  IL-13 in asthma and allergic disease: asthma phenotypes and targeted therapies. , 2012, The Journal of allergy and clinical immunology.

[16]  E. Lacy.  Equilibrium and kinetic analysis of human interleukin‐13 and IL‐13 receptor alpha‐2 complex formation , 2012, Journal of molecular recognition : JMR.

[17]  Lee， Jk,et al.  Lebrikizumab treatment in adults with asthma. , 2011 .

[18]  K. Marquette,et al.  IL-13 Antibodies Influence IL-13 Clearance in Humans by Modulating Scavenger Activity of IL-13Rα2 , 2011, The Journal of Immunology.

[19]  C. Cuff,et al.  In Vivo Characterization Of ABT-308, A Potent Anti-IL-13 Antibody For The Treatment Of Asthma , 2010, ATS 2010.

[20]  C. Cuff,et al.  ABT-308, A Highly Potent Anti-IL-13 Therapeutic Antibody For The Treatment Of Human Asthma , 2010, ATS 2010.

[21]  Sally E Wenzel,et al.  A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. , 2010, American journal of respiratory and critical care medicine.

[22]  F. Finkelman,et al.  IL-13Rα2 Membrane and Soluble Isoforms Differ in Humans and Mice1 , 2009, The Journal of Immunology.

[23]  S. Aceves,et al.  Relationships between eosinophilic inflammation, tissue remodeling, and fibrosis in eosinophilic esophagitis. , 2009, Immunology and allergy clinics of North America.

[24]  I. Pavord,et al.  Increased sputum and bronchial biopsy IL-13 expression in severe asthma. , 2008, The Journal of allergy and clinical immunology.

[25]  M. Vicario,et al.  IL-13 involvement in eosinophilic esophagitis: transcriptome analysis and reversibility with glucocorticoids. , 2007, The Journal of allergy and clinical immunology.

[26]  R. Sadhukhan,et al.  Development of an in vitro potency bioassay for therapeutic IL-13 antagonists: The A-549 cell bioassay , 2006 .

[27]  P. Bugelski,et al.  Therapeutic Dosing with Anti-Interleukin-13 Monoclonal Antibody Inhibits Asthma Progression in Mice , 2005, Journal of Pharmacology and Experimental Therapeutics.

[28]  Jack A. Elias,et al.  Acidic Mammalian Chitinase in Asthmatic Th2 Inflammation and IL-13 Pathway Activation , 2004, Science.

[29]  G. Hershey.  IL-13 receptors and signaling pathways: an evolving web. , 2003, The Journal of allergy and clinical immunology.

[30]  E. Gelfand,et al.  The Role of IL-13 in Established Allergic Airway Disease1 , 2002, The Journal of Immunology.

[31]  D. Umetsu,et al.  Critical Role for IL-13 in the Development of Allergen-Induced Airway Hyperreactivity1 , 2001, The Journal of Immunology.

[32]  K. Deichmann,et al.  Genetic variants of IL-13 signalling and human asthma and atopy. , 2000, Human molecular genetics.

[33]  R. Homer,et al.  Pulmonary expression of interleukin-13 causes inflammation, mucus hypersecretion, subepithelial fibrosis, physiologic abnormalities, and eotaxin production. , 1999, The Journal of clinical investigation.

[34]  D B Corry,et al.  Requirement for IL-13 independently of IL-4 in experimental asthma. , 1998, Science.

[35]  D D Donaldson,et al.  Interleukin-13: central mediator of allergic asthma , 1998 .

[36]  D D Donaldson,et al.  The murine IL-13 receptor alpha 2: molecular cloning, characterization, and comparison with murine IL-13 receptor alpha 1. , 1998, Journal of immunology.

[37]  M. Isobe,et al.  Interleukin-13 but not interleukin-4 prolongs eosinophil survival and induces eosinophil chemotaxis. , 1997, Internal medicine.

[38]  R. Puri,et al.  cDNA Cloning and Characterization of the Human Interleukin 13 Receptor α Chain* , 1996, The Journal of Biological Chemistry.

[39]  W. Luttmann,et al.  Activation of human eosinophils by IL-13. Induction of CD69 surface antigen, its relationship to messenger RNA expression, and promotion of cellular viability. , 1996, Journal of immunology.

[40]  J. G. Zhang,et al.  Cloning and characterization of a binding subunit of the interleukin 13 receptor that is also a component of the interleukin 4 receptor. , 1996, Proceedings of the National Academy of Sciences of the United States of America.

[41]  L. Lichtenstein,et al.  IL-13 expression at the sites of allergen challenge in patients with asthma. , 1995, Journal of immunology.

[42]  R. de Waal Malefyt,et al.  Interleukin 13 induces interleukin 4-independent IgG4 and IgE synthesis and CD23 expression by human B cells. , 1993, Proceedings of the National Academy of Sciences of the United States of America.

[43]  M. Collins,et al.  A striking local esophageal cytokine expression profile in eosinophilic esophagitis. , 2011, The Journal of allergy and clinical immunology.

[44]  P. Richardson,et al.  Functional comparison of recombinant acidic mammalian chitinase with enzyme from murine bronchoalveolar lavage. , 2011, Protein expression and purification.

[45]  R. Puri,et al.  IL-13 signaling through the IL-13α2 receptor is involved in induction of TGF-β1 production and fibrosis , 2006, Nature Medicine.

[46]  T. Wynn,et al.  Opposing roles for IL-13 and IL-13 receptor alpha 2 in health and disease. , 2004, Immunological reviews.

[47]  木部 敦子.  Differential regulation by glucocorticoid of interleukin-13-induced eosinophilia, hyperresponsiveness, and goblet cell hyperplasia in mouse airways , 2003 .