Challenges and approaches for the development of safer immunomodulatory biologics (Q38093772)

28 August 2017

Challenges and approaches for the development of safer immunomodulatory biologics (English)

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28 August 2017

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28 August 2017

Jean G Sathish

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Neil S French

object named as

Neil S French

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Stephen T. Holgate

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object named as

Stephen Holgate

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Swaminathan Sethu

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David Jones

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Marie-Christine Bielsky

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28 August 2017

Lolke de Haan

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28 August 2017

Karthik Govindappa

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James Green

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Christopher E M Griffiths

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Ian Kimber

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Jonathan Moggs

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Dean J Naisbitt

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Gabriele Reichmann

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28 August 2017

Jennifer Sims

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28 August 2017

Meena Subramanyam

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Marque D Todd

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Jan Willem Van Der Laan

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28 August 2017

Richard J Weaver

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B Kevin Park

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1 April 2013

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Nature Reviews Drug Discovery

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https://scigraph.springernature.com/pub.10.1038/nrd3974

28 August 2017

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Risk of natalizumab-associated progressive multifocal leukoencephalopathy

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Short-term risk of total malignancy and nonmelanoma skin cancers with certolizumab and golimumab in patients with rheumatoid arthritis: metaanalysis of randomized controlled trials

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Susceptibility of patients with rheumatic diseases to B-cell non-Hodgkin lymphoma.

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Belatacept : a new biological agent for maintenance immunosuppression in kidney transplantation

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Adverse consequences of immunostimulation

21 January 2018

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Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412

21 January 2018

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Anaphylactic shock after retreatment with OKT3 monoclonal antibody

21 January 2018

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Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy

21 January 2018

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Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies

21 January 2018

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Surprising negative association between IgG1 allotype disparity and anti-adalimumab formation: a cohort study

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21 January 2018

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Structural characterization of a human Fc fragment engineered for lack of effector functions

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Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell-mediated B-cell cytotoxicity

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Glycosylation as a strategy to improve antibody-based therapeutics

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Lebrikizumab treatment in adults with asthma

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21 January 2018

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Histopathologic approaches to detect changes indicative of immunotoxicity

21 January 2018

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Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

21 January 2018

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Opportunistic infections in non-human primates exposed to immunomodulatory biotherapeutics: considerations and case examples

21 January 2018

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Host resistance assays including bacterial challenge models

21 January 2018

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Regulation of human cell engraftment and development of EBV-related lymphoproliferative disorders in Hu-PBL-scid mice

21 January 2018

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In vitro cytokine release assays: reducing the risk of adverse events in man.

21 January 2018

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In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European Medicines Agency Workshop.

21 January 2018

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The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

21 January 2018

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Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies

21 January 2018

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Thyrotropin receptor epitopes and their relation to histocompatibility leukocyte antigen-DR molecules in Graves' disease

21 January 2018

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A systematic bioinformatics approach for selection of epitope-based vaccine targets

21 January 2018

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From genome to vaccine—new immunoinformatics tools for vaccine design

21 January 2018

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Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein.

21 January 2018

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Reducing risk, improving outcomes: bioengineering less immunogenic protein therapeutics

21 January 2018

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Predicting linear B-cell epitopes using string kernels

21 January 2018

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Improved method for predicting linear B-cell epitopes

21 January 2018

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Analysis and prediction of protective continuous B-cell epitopes on pathogen proteins.

21 January 2018

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Aggregation in protein-based biotherapeutics: computational studies and tools to identify aggregation-prone regions

21 January 2018

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Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity.

21 January 2018

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Overview of cell-based tools for pre-clinical assessment of immunogenicity of biotherapeutics

21 January 2018

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Immunogenicity of protein therapeutics: The key causes, consequences and challenges

21 January 2018

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Peptide-binding assays and HLA II transgenic Abeta degrees mice are consistent and complementary tools for identifying HLA II-restricted peptides.

21 January 2018

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Development of functional human blood and immune systems in NOD/SCID/IL2 receptor {gamma} chain(null) mice

21 January 2018

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A new Hu-PBL model for the study of human islet alloreactivity based on NOD-scid mice bearing a targeted mutation in the IL-2 receptor gamma chain gene.

21 January 2018

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Immunogenicity of therapeutic proteins: the use of animal models

21 January 2018

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Anti-TNF antibody therapy for inflammatory bowel disease during pregnancy: a clinical review

21 January 2018

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Antagonizing the α4β1 integrin, but not α4β7, inhibits leukocytic infiltration of the central nervous system in rhesus monkey experimental autoimmune encephalomyelitis

21 January 2018

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Pharmacokinetics and tolerability of human mouse chimeric anti-CD22 monoclonal antibody in Chinese patients with CD22-positive non-Hodgkin lymphoma

21 January 2018

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Interferon beta inhibits the Th17 cell-mediated autoimmune response in patients with relapsing-remitting multiple sclerosis

21 January 2018

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Pharmacokinetic and pharmacodynamic properties of TRU-015, a CD20-directed small modular immunopharmaceutical protein therapeutic, in patients with rheumatoid arthritis: a Phase I, open-label, dose-escalation clinical study

21 January 2018

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Monoclonal antibodies and fusion proteins and their complications: targeting B cells in autoimmune diseases

21 January 2018

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Complement activation plays a key role in antibody-induced infusion toxicity in monkeys and rats

21 January 2018

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Blinatumomab: a historical perspective

21 January 2018

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Multiple signaling pathways induced by hexavalent, monospecific, anti-CD20 and hexavalent, bispecific, anti-CD20/CD22 humanized antibodies correlate with enhanced toxicity to B-cell lymphomas and leukemias

21 January 2018

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Bispecific anti-CD20/22 antibodies inhibit B-cell lymphoma proliferation by a unique mechanism of action

21 January 2018

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Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry

21 January 2018

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The safety profile of infliximab in patients with Crohn's disease: the Mayo clinic experience in 500 patients

21 January 2018

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Infliximab safety profile and long-term applicability in inflammatory bowel disease: 9-year experience in clinical practice

21 January 2018

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TNF-α antagonist use and risk of hospitalization for infection in a national cohort of veterans with rheumatoid arthritis

21 January 2018

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Serious infections during anti-TNFalpha treatment in rheumatoid arthritis patients.

21 January 2018

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Use of biologics in rheumatoid arthritis: current and emerging paradigms of care

21 January 2018

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Reactivation of occult hepatitis B virus infection, following treatment of refractory rheumatoid arthritis with abatacept

21 January 2018

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Rational development of LEA29Y (belatacept), a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties.

21 January 2018

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Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy.

21 January 2018

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Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists

21 January 2018

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Infections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association?

21 January 2018

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Safety of rituximab in rheumatoid arthritis: a long-term prospective single-center study of gammaglobulin concentrations and infections

21 January 2018

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Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks

21 January 2018

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Safety of extended treatment with anakinra in patients with rheumatoid arthritis

21 January 2018

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The yin and yang of immunomodulatory biologics: assessing the delicate balance between benefit and risk

21 January 2018

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The emergence of progressive multifocal leukoencephalopathy (PML) in rheumatic diseases

21 January 2018

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Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a Review from the Research on Adverse Drug Events and Reports (RADAR) Project

21 January 2018

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OKT3 and ganciclovir treatments are possibly related to the presence of Epstein-Barr virus in serum after liver transplantation

21 January 2018

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A multicenter, open-label study of repeat courses of intramuscular alefacept in combination with other psoriasis therapies in patients with chronic plaque psoriasis

21 January 2018

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Loss of Siglec expression on T lymphocytes during human evolution

21 January 2018

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Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets

21 January 2018

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Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets

21 January 2018

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Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells

21 January 2018

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Topological requirements and signaling properties of T cell-activating, anti-CD28 antibody superagonists

21 January 2018

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CR1 and CR1-like: the primate immune adherence receptors

21 January 2018

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Structural and Functional Analysis of a C3b-specific Antibody That Selectively Inhibits the Alternative Pathway of Complement

21 January 2018

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Different adaptations of IgG effector function in human and nonhuman primates and implications for therapeutic antibody treatment.

21 January 2018

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Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study.

21 January 2018

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Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions

21 January 2018

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On the role of aggregates in the immunogenicity of recombinant human interferon beta in patients with multiple sclerosis

21 January 2018

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Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses

21 January 2018

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Rationally engineered therapeutic proteins with reduced immunogenicity.

21 January 2018

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Activation of natural regulatory T cells by IgG Fc-derived peptide "Tregitopes"

21 January 2018

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Structure-function engineering of interferon-beta-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEGylation

21 January 2018

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PEGylation of therapeutic proteins

21 January 2018

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Antibody against poly(ethylene glycol) adversely affects PEG-asparaginase therapy in acute lymphoblastic leukemia patients

21 January 2018

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Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase

21 January 2018

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Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins

21 January 2018

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The impact of glycosylation on HLA-DR1-restricted T cell recognition of type II collagen in a mouse model.

21 January 2018

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Impact of product-related factors on immunogenicity of biotherapeutics

21 January 2018

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Effect of oromucosal administration of IFN-alpha on allergic sensitization and the hypersensitive inflammatory response in animals sensitized to ragweed pollen

21 January 2018

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Influence of Immunogenicity on the Long-Term Efficacy of Infliximab in Crohn's Disease

21 January 2018

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How tolerogenic dendritic cells induce regulatory T cells

21 January 2018

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What does the future hold for cell-based tolerogenic therapy?

21 January 2018

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Genome sequencing and comparison of two nonhuman primate animal models, the cynomolgus and Chinese rhesus macaques.

21 January 2018

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Diversity of MHC class I haplotypes in cynomolgus macaques

21 January 2018

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Incidences and range of spontaneous findings in control cynomolgus monkeys (Macaca fascicularis) used in toxicity studies

21 January 2018

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Alternative strategies for toxicity testing of species-specific biopharmaceuticals

21 January 2018

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Evaluation of a surrogate antibody for preclinical safety testing of an anti-CD11a monoclonal antibody

21 January 2018

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Tissue-type plasminogen activator promotes murine myofibroblast activation through LDL receptor-related protein 1-mediated integrin signaling

21 January 2018

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Rituximab specifically depletes short-lived autoreactive plasma cells in a mouse model of inflammatory arthritis

21 January 2018

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Recombinant and natural human interferons: analysis of the incidence and clinical impact of neutralizing antibodies

21 January 2018

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Alemtuzumab vs. interferon beta-1a in early multiple sclerosis

21 January 2018

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Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation

21 January 2018

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Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients

21 January 2018

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Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study

21 January 2018

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Long-term complete responses after 131I-tositumomab therapy for relapsed or refractory indolent non-Hodgkin's lymphoma

21 January 2018

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Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up

21 January 2018

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A case of progressive multifocal leukoencephalopathy in a patient treated with infliximab

21 January 2018

1 reference

Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection

21 January 2018

1 reference

Subset analysis of patients experiencing clinical events of a potentially immunogenic nature in the pivotal clinical trials of tocilizumab for rheumatoid arthritis: Evaluation of an antidrug antibody ELISA using clinical adverse event-driven immunog

21 January 2018

1 reference

Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: A twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial

21 January 2018

1 reference

Efficient expansion of regulatory T cells in vitro and in vivo with a CD28 superagonist

21 January 2018

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A Novel Strategy To Reduce the Immunogenicity of Biological Therapies

21 January 2018

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Antibody Response to Aggregated Human Interferon Alpha2b in Wild-type and Transgenic Immune Tolerant Mice Depends on Type and Level of Aggregation

21 January 2018

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Development of a human whole blood assay for prediction of cytokine release similar to anti-CD28 superagonists using multiplex cytokine and hierarchical cluster analysis

21 January 2018

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Anaphylactic shock caused by immunoglobulin E sensitization after retreatment with the chimeric anti-interleukin-2 receptor monoclonal antibody basiliximab

31 March 2020

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Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab

31 March 2020

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Anti-adalimumab antibodies in rheumatoid arthritis patients are associated with interleukin-10 gene polymorphisms

31 March 2020

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The effect of the removal of sialic acid, galactose and total carbohydrate on the functional activity of Campath-1H

31 March 2020

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Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations

31 March 2020

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STP position paper: best practice guideline for the routine pathology evaluation of the immune system

31 March 2020

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The T-dependent antibody response to keyhole limpet hemocyanin in rodents

31 March 2020

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Summary of roundtable discussion meeting: non-human primates to assess risk for EBV-related lymphomas in humans

31 March 2020

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A predictive biomimetic model of cytokine release induced by TGN1412 and other therapeutic monoclonal antibodies

31 March 2020

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The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development

31 March 2020

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Relationship between potential aggregation-prone regions and HLA-DR-binding T-cell immune epitopes: implications for rational design of novel and follow-on therapeutic antibodies

31 March 2020

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Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays

31 March 2020

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Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up

31 March 2020

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Ustekinumab shows promise in the treatment of refractory Crohn's disease

31 March 2020

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Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study

31 March 2020

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Comparative effectiveness and safety of biological treatment options after tumour necrosis factor α inhibitor failure in rheumatoid arthritis: systematic review and indirect pairwise meta-analysis

31 March 2020

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Autoimmune hepatitis induced by adalimumab with successful switch to abatacept

31 March 2020

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Legionella pneumophila pneumonia in a pregnant woman treated with anti-TNF-α antibodies for Crohn's disease: a case report

31 March 2020

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Repeated B lymphocyte depletion with rituximab in rheumatoid arthritis over 7 yrs

31 March 2020

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The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial

31 March 2020

1 reference

Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo-controlled trial

31 March 2020

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Posttransplantation lymphoproliferative disorder associated with OKT3 and decreased antiviral prophylaxis in pancreas transplant recipients

31 March 2020

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Transient accumulation of human mature thymocytes and regulatory T cells with CD28 superagonist in "human immune system" Rag2(-/-)gammac(-/-) mice

31 March 2020

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CD28-mediated induction of proliferation in resting T cells in vitro and in vivo without engagement of the T cell receptor: evidence for functionally distinct forms of CD28

31 March 2020

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"Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics

31 March 2020

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Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance by human interferon beta

31 March 2020

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Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice

31 March 2020

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Induction of tolerance to recombinant therapeutic proteins

31 March 2020

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Mucosal antigen presentation and the control of tolerance and immunity

31 March 2020

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Deal watch: Boosting TRegs to target autoimmune disease

31 March 2020

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Treatment with CD20-specific antibody prevents and reverses autoimmune diabetes in mice

31 March 2020

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Anaphylaxis after administration of ibritumomab tiuxetan for follicular non-hodgkin lymphoma

31 March 2020

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Monoclonal antibody therapy. Anti-idiotypic and non-anti-idiotypic antibodies to OKT3 arising despite intense immunosuppression

31 March 2020

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Occurrence of antibodies against natalizumab in relapsing multiple sclerosis patients treated with natalizumab

31 March 2020

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De-immunization of therapeutic proteins by T-cell epitope modification.

31 March 2020

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12 December 2020

Interferon immunogenicity: preclinical evaluation of interferon-alpha 2a

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12 December 2020

Expression of GnTIII in a recombinant anti-CD20 CHO production cell line: Expression of antibodies with altered glycoforms leads to an increase in ADCC through higher affinity for FC gamma RIII.

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12 December 2020

Hypersensitivity to aldesleukin (interleukin-2 and proleukin) presenting as facial angioedema and erythema

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12 December 2020

Creation of "humanized" mice to study human immunity

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12 December 2020

Identification and removal of immunogenicity in therapeutic proteins.

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12 December 2020

Development of TNF inhibitor therapies for the treatment of rheumatoid arthritis

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12 December 2020

Determining genetic background in captive stocks of cynomolgus macaques (Macaca fascicularis).

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12 December 2020

HLA-DR4 (DRB1*0401) transgenic mice expressing an altered CD4-binding site: specificity and magnitude of DR4-restricted T cell response

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12 December 2020

Anti-TNF agents for the treatment of psoriasis.

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12 December 2020

Prediction of immunogenicity for therapeutic proteins: state of the art.

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12 December 2020

Identifiers

DOI

10.1038/NRD3974

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28 August 2017

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