Biologics in General Medicine is the first book to cover every angle in the clinical application of biologics.

Readers will find that all of the biologics currently approved for clinical use are delineated in a standardized way, including crucial information that is of practical use in the field, such as contra-indications or monitoring needs.

Readers will also find covered the whole area of "differential therapy" with biologics in fields such as:

• dermatology
• neurology
• rheumatology
• gastroenterology

This differential therapy is described in detail and summarized in treatment algorithms.

While these more clinically oriented chapters form the core of Biologics in General Medicinet, the editors have taken care to ensure that other issues are covered too.

Contents

1. Definition and Classification of Biologics

Development and Pre-clinical Pharmacology of Biologics

2. Infliximb: From the Idea to the Product

• Characteristics and Biological Activity
• Administration
• Therapeutic Indications
• Pharmacokinetics
• Relationship Between Infliximab Concentration and Clinical Response
• Antibody Formation Against Infliximab
• Infusion Reactions/Delayed Hypersensitivity Reactions
• Alternative Routes of Administration

3. Adalimumab

• Pharmacology
• Indications
• Pivotal Studies in Rheumatoid Arthritis
• Adalimumab Plus Methotrexate
• Pivotal Studies in Psoriatic Arthritis
• Pivotal Study in Ankylosing Spondylitis
• Psoriasis
• Safety

4. Etanercept

• Structure
• Pharmacokinetics
• Absorption
• Distribution
• Metabolism and Elimination
• Age
• Gender
• Patients with Renal or Hepatic Insufficiency
• Drug Interactions
• Pharmacodynamics
• Mode of Action
• Pharmacodynamics in Disease States

5. Efalizumab: Antibody Characteristics, Mode of Action and Preclinical Development

• Developement and Characterization of the Antibody
• Efalizumab: From Mode of Action to the Treatment of Psoriasis
• Pharmacology and Toxicology of Efalizumab

6. Monoclonal Antibody Target Radiation Cancer Therapy

• Introduction and Background
• The Radioiotope
• Linking the Radionuclide to Protein
• The Protein Vehicle

7. The Production of Biopharmaceuticals

• The Sucess of Modern Biotechnology
• The Science and Technology Behind Modern Biopharmaceuticals
• Process Development
• Biopharmaceutical Manufacturing
• Quality Assurance and Qualtiy Control
• Facility Considerations
• Biosimilar Products

Disease-Specific Applications and Clinical Trials

8. Treating Autoimmune Bullous Skin Disorders with Biologics

• Rituximab in the Treatment of Autoimmune Bullous Skin Disorders
• Inhibitors of TNF-a in the Treatment of Autoimmune Bullous Skin Disorders

9. Biologics in Psoriasis

• Psoriasis
• Mechanisms of Disease
• Etanercepts
• Efalizumab
• Alefacept
• Infliximab
• Adalimumab

10. Biologic Agents in Psoriatic Arthritis

• Classification and Epidemiology
• Genetic Epidemiolgy
• Immunopathology
• Clinical Features
• Outcome Measures
• Treatment
• Biologic Agents
• Other Biologic Agents
• Other Potential Treatments
• Cost-Effectiveness Analysis

11. Biologic Therapies for Eheumatoid Arthritis Targeting TNF-a and IL-1

• Biologic Therapies Targeting TNF-a
• Targeting IL-1
• Combination Anti-cytokine Therapies

12. Biologics in Crohn's Disease and Ulcerative Colitis: Focus on Tumor Necrosis Factor Antagoists

• Clinical Features of Crohn's Disease
• Pathogenesis of Crohn's Disease
• Biologics for Use in Crohn's Disease
• Biologics in Ulcerative Colitis

13. Multiple Sclerosis: New Immunobiologics

• Immunopathogenesis of Multiple Sclerosis
• Prominent Failure of TNF-a Targeting
• Adverse Reactions in Highly Efficacious Anti-a4-Integrin Therapy with Natalizumab
• Currently Investigated Monoclonal Antibodies

14.Biologics in Cutaneous Lymphoma

• Cutaneous T-Cell Lymphomas
• Biologics in the Treatment of CTCL

15. Biologics in Targeted Cancer Therapy

• Chemoimmunoconjugates
• Immunotoxins
• Antibody-Cytokine Fusion Proteins
• Evolving Approaches

Safety and Perspectives

16. Safety Aspects of Biologics: Lesson Learnt from Monoclonal Antibodies

• Intervention with Pleiotropic Cytokine Pathways
• Intervention with Adhesion Molecules
• Interventions with Growth Factor Receptors

17. New Biological Therapeutics in the Genome Age

• Early Biotechnology Production of Human Cytokines and Hormones
• Finding New Cytokine Orphans in the Human Genome: Early Excitement from Expressed Sequence Tags
• Assembling the Complete Protein Collection: The Serono Secretome
• Moving from the Protein to the Biological Activity: The Post-Genome Era
• Strategies for Blocking Responses

18. Evidence Based Medicine's Perspective on Biologics

• What is EBM?
• EBM Steps to Treating an Individual Patient
• German S3 Guidelines for the Treatment of Plaque Psoriasis
• EBM and Biologics
• Where Do Biologics Stand Among Other Systemic Treatments of Psoriasis?

Index

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