Adverse Reactions to Biologics

Adverse Reactions to Biologics
Author: L. Puig
Publisher: Karger Medical and Scientific Publishers
Total Pages: 120
Release: 2017-11-07
Genre: Medical
ISBN: 3318061018

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In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field.

Safety of Biologics Therapy

Safety of Biologics Therapy
Author: Brian A. Baldo
Publisher: Springer
Total Pages: 623
Release: 2016-08-12
Genre: Medical
ISBN: 3319304720

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This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

Immunogenicity of Biopharmaceuticals

Immunogenicity of Biopharmaceuticals
Author: Marco Weert
Publisher: Springer Science & Business Media
Total Pages: 269
Release: 2008-02-06
Genre: Medical
ISBN: 0387758410

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Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

Immunogenicity of Proteins Used as Therapeutics

Immunogenicity of Proteins Used as Therapeutics
Author: Amy Rosenberg
Publisher: Frontiers Media SA
Total Pages: 328
Release: 2020-12-28
Genre: Medical
ISBN: 2889662888

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Topic Editor Susan Richards is an employee of Sanofi and owns stock in the corporation. Topic Editor Bernard Maillere declares economic support from pharmaceutical companies (Novartis, Sanofi, and UCB) in the frame of collaborations aiming to evaluate the recognition by human T cells of therapeutic proteins and antibodies.

Immunogenicity of Therapeutic Biological Products

Immunogenicity of Therapeutic Biological Products
Author: Fred Brown
Publisher: S. Karger AG (Switzerland)
Total Pages: 196
Release: 2003
Genre: Medical
ISBN:

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Immune responses to biological products have occurred with many approved therapeutics. The proportion of patients mounting an immune response is product dependent and the clinical significance of the immune response also varies with the nature of the product. Some products can induce production of significant levels of antibodies without any detectable effect on the activity of the product. However, neutralizing antibodies can attenuate the efficacy of the treatment and significant adverse clinical events can be seen if neutralizing antibodies cross-react with patients' endogenous proteins. Prediction of immunogenicity includes the use of bio-informatics to predict T-cell epitopes, T-cell stimulation assays and in vivo transgenic animal models. Approaches to prevent immunogenicity involve methods to design out immunogenic sequences, protein pegylation and inducing tolerance. Current methods for assessing and detecting immunogenicity include in vivo animal models, antibody assays and biological assays. The advantages and disadvantages of the various methods illustrate that a battery of tests is required to appropriately monitor patients' immune responses during clinical trials.

Targeted Cancer Immune Therapy

Targeted Cancer Immune Therapy
Author: Joseph Lustgarten
Publisher: Springer Science & Business Media
Total Pages: 340
Release: 2009-10-09
Genre: Medical
ISBN: 1441901701

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Stimulation of the immune system’s ability to control and destroy tumors cont- ues to be the goal of cancer immune therapy; but the scope has rapidly expanded; approaches are constantly updated; new molecules are continually introduced; and immune mechanisms are becoming better understood. This book has no intention of covering every aspect of immune therapy but rather focuses on the novelty of cancer immune therapy in an attempt to give readers an opportunity to absorb the new aspects of immune therapy from a single source. In this regard, three areas were selected: cytokine immune therapy, cell-based immune therapy, and targeted immune therapy. In each of these three sections, only the novel aspects of immune therapy were described instead of attempting to cover any historical achievement. In the first section, Cytokine Immune Therapy, the IL12 family, IL18, IL21, IL24, IL28, and IL29 were emphasized in regard to the an- tumor function and application in treating tumors. Most of these selected cyt- ines were discovered in last 10 years. In the second section, Cell-based Immune Therapy, the focus was engineering potent immune regulatory or effector cells such as dendritic cells, T cells, and stem cells. Cell engineering design is primarily based on the increased understanding of the interaction of tumor antigen-presenting cells, antigen- specific effector cells, and the tumor microenvironment.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 442
Release: 2011-04-03
Genre: Medical
ISBN: 0309158060

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Statistical Methods for Immunogenicity Assessment

Statistical Methods for Immunogenicity Assessment
Author: Harry Yang
Publisher: CRC Press
Total Pages: 259
Release: 2015-07-17
Genre: Mathematics
ISBN: 1498700357

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Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra

Drug Hypersensitivity

Drug Hypersensitivity
Author: Werner J. Pichler
Publisher: Karger Medical and Scientific Publishers
Total Pages: 440
Release: 2007-01-01
Genre: Medical
ISBN: 3805582692

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Approaches the phenomenon of drug hypersensitivity in a comprehensive manner. Besides epidemiological aspects, it addresses the immunological mechanisms underlying these complicated reactions which go far beyond the IgE-mediated drug allergies also considered in this book. The book also covers clinical manifestations and new diagnostic methods, and introduces some recetly established animal models. Many topics are treated from multiple perspectives, and the 33 chapters are thoroughly cross-referenced.