Immunotherapy in Transplantation: Principles and Practice PDF
Preview Immunotherapy in Transplantation: Principles and Practice
Immunotherapy in Transplantation 00000011446688118877..IINNDDDD ii 22//11//22001122 77::4477::2277 PPMM Immunotherapy in Transplantation Principles and Practice EDITED BY Bruce Kaplan MD Kathy and Harry Jentsch Professor of Medicine Professor of Surgery and Pharmacology Chief, Division of Nephrology Medical Director of Abdominal Transplant University of Arizona Medical Center Tucson, AZ, USA; Adjunct Professor of Medicine, Applied Genomics Center University of Alberta Edmonton, AB, Canada Gilbert J. Burckart PharmD Associate Director, Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring, MD, USA Fadi G. Lakkis MD Professor of Surgery, Immunology and Medicine Frank & Athena Sarris Chair in Transplantation Biology Scientific Director, Thomas E. Starzl Transplantation Institute University of Pittsburgh Pittsburgh, PA, USA A John Wiley & Sons, Ltd., Publication 00000011446688118877..IINNDDDD iiiiii 22//11//22001122 77::4477::2277 PPMM This edition first published 2012 © 2012 by Blackwell Publishing Ltd. Blackwell Publishing was acquired by John Wiley & Sons in February 2007. Blackwell’s publishing program has been merged with Wiley’s global Scientific, Technical and Medical business to form Wiley-Blackwell. 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The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of fitness for a particular purpose. In view of ongoing research, equipment modifications, changes in governmental regulations, and the constant flow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Immunotherapy in transplantation : principles and practice / edited by Bruce Kaplan, Gilbert J. Burckart, Fadi G. Lakkis. p. ; cm. Includes bibliographical references and index. ISBN 978-1-4051-8271-3 (hard cover : alk. paper) I. Kaplan, Bruce, 1958– II. Burckart, Gilbert J. III. Lakkis, Fadi G. [DNLM: 1. Transplantation Immunology–drug effects. 2. Transplantation Immunology–physiology. 3. Immunosuppressive Agents–pharmacology. 4. Immunotherapy–methods. 5. Pharmacology, Clinical–methods. 6. Transplantation–physiology. WO 680] 615.3′7–dc23 2011035464 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Set in 9/12pt Meridien by SPi Publisher Services, Pondicherry, India 1 2012 00000011446688118877..IINNDDDD iivv 22//11//22001122 77::4477::2277 PPMM Contents List of Contributors, vii Preface, xi Part 1 Transplantation Immunobiology 1 The Immune Response to a Transplanted Organ: An Overview, 3 Fadi G. Lakki s 2 Antigen Presentation in Transplantation, 10 Martin H. Oberbarnscheidt and Fadi G. Lakkis 3 The T Cell Response to Transplantation Antigens, 19 Didier A. Mandelbrot, Bryna Burrell, Mohamed H. Sayegh, and Peter S. Heeger 4 The B Cell Response to Transplantation Antigens, 38 Roger Sciammas, Anita S. Chong, and Robert B. Colvin 5 The Innate Response to a Transplanted Organ, 54 Daniel R. Goldstein and Laurence A. Turka 6 Regulation of the Alloimmune Response, 62 Kathryn J. Wood and Terry B. Strom Part 2 Transplantation Clinical Pharmacology 7 Pharmacokinetics, 81 Venkateswaran C. Pillai and Raman Venkataramanan 8 Therapeutic Drug Monitoring for Immunosuppressive Agents, 95 Michael C. Milone and Leslie M.J. Shaw 9 Pharmacometrics: Concepts and Applications to Drug Development, 114 Mallika Lala and Jogarao V.S. Gobburu 10 Pharmacogenomics and Organ Transplantation, 133 Gilbert J. Burckart and Richard M. Watanabe 1 1 Study Design/Process of Development: Clinical Studies, 146 Richard D. Mamelok Part 3 Agents 12 Corticosteroids, 163 Olivia R. Blume, Sarah E. Yost, and Bruce Kaplan 1 3 Azathioprine, 171 Barry J. Browne 00000011446688118899..IINNDDDD vv 22//11//22001122 77::5511::4433 PPMM vi Contents 14 Pharmacokinetic and Pharmacodynamic Properties of Mycophenolate, 182 David Hager, Arjang Djamali, and Bruce Kaplan 15 Cyclosporine: Molecular Action to Clinical Therapeutics, 197 Bradford Strijack and Paul A. Keown 16 Tacrolimus, 224 William E. Fitzsimmons 17 Inhibitors of Mammalian Target of Rapamycin, 241 Barry D. Kahan 18 Inhibitors Targeting JAK3, 273 Gary Chan and Paul S. Changelian 19 Cyclophosphamide, 290 John J. Curtis 20 Application of Antisense Technology in Medicine, 296 Beata Mierzejewska and Stanislaw M. Stepkowski 21 The Role of Ganciclovir in Transplantation, 316 Lyndsey J. Bowman and Daniel C. Brennan 22 Transplantation Immunotherapy with Antithymocyte Globulin (ATG), 330 John L. Dzuris, Christian Bloy, Melanie Ruzek, and John M. Williams 23 The Role of Alemtuzumab in Solid Organ Transplantation, 346 Avinash Agarwal, David Bruno, and Stuart J. Knechtle 24 Rituximab, an Anti-CD20 Monoclonal Antibody, 362 Mark D. Pescovitz 25 The Anti-Interleukin 2 Receptor Antibodies, 378 Muna Alnimri and Flavio Vincenti 26 Infl iximab/Anti-TNF, 385 Marina Vardanyan, Edward C. Parkin, and Horacio L. Rodriguez Rilo 2 7 CTLA4-Ig, 399 Sarah E. Yost and Bruce Kaplan 28 Combination and Adjuvant Therapies to Facilitate the Effi cacy of Costimulatory Blockade, 407 Swetha K. Srinivasan, Helen L. Triemer, and Allan D. Kirk 29 Intravenous Immunoglobulin (IVIG) a Modulator of Immunity and Infl ammation with Applications in Solid Organ Transplantation, 429 Stanley C. Jordan, Mieko Toyoda, Joseph Kahwaji, Alice Peng, and Ashley A. Vo Index, 447 Color plates are found facing p. 213 00000011446688118899..IINNDDDD vvii 22//11//22001122 77::5511::4433 PPMM List of Contributors Avinash Agarwal MD US Food and Drug Administration Department of Surgery and the Emory Transplant Center Silver Spring, MD, USA Emory University Bryna Burrell PhD Atlanta, GA, USA Postdoctoral Fellow Muna Alnimri MD Mount Sinai School of Medicine Instructor in Medicine New York, NY, USA University of California Gary Chan PharmD, MS San Francisco Transplant Service San Francisco, CA, USA Senior Director Clinical Development Christian Bloy PhD Specialty Care Business Unit Senior Director R&D Pfizer Genzyme Corporation Groton, CT, USA Lyon, France Paul S. Changelian PhD Olivia R. Blume PA-C Vice President, Biology Abdominal Transplant Service Lycera Corporation University of Arizona Medical Center Plymouth, MI, USA Tucson, AZ, USA Anita S. Chong PhD Lyndsey J. Bowman PharmD Professor of Surgery Clinical Pharmacist, Abdominal Transplant Department of Surgery / Section of Transplantation Barnes-Jewish Hospital University of Chicago St. Louis, MO, USA Chicago, IL, USA Daniel C. Brennan MD, FACP Robert B. Colvin MD Professor of Medicine Professor of Pathology Washington University in St. Louis; Massachusetts General Hospital; Director, Transplant Nephrology Professor of Pathology St. Louis, MO, USA Harvard Medical School Boston, MA, USA Barry J. Browne MD, MS, FACS John J. Curtis MD Director, Abdominal Transplantation Balboa Institute of Transplantation Professor of Medicine and Surgery San Diego, CA, USA Endowed Professor of Transplant Nephrology Division of Nephrology David Bruno MD University of Alabama at Birmingham Department of Surgery and the Emory Transplant Center Birmingham, AL, USA Emory University Arjang Djamali MD, MS, FASN Atlanta, GA, USA Associate Professor of Medicine-Surgery Gilbert J. Burckart PharmD Chief, Nephrology Division Associate Director, Office of Clinical Pharmacology University of Wisconsin-Madison Center for Drug Evaluation and Research Madison, WI, USA vii 00000011446688118866..IINNDDDD vviiii 22//11//22001122 77::4455::3311 PPMM viii List of Contributors John L. Dzuris PhD Bruce Kaplan MD, PhD Assistant Director Kathy and Harry Jentsch Professor of Medicine Transplant and Immunology Research Professor of Surgery and Pharmacology Genzyme Corporation Chief, Division of Nephrology Framingham, MA, USA Medical Director of Abdominal Transplant University of Arizona Medical Center William E. Fitzsimmons PharmD, MS Tucson, AZ, USA; Adjunct Professor of Medicine, Applied Genomics Center Senior Vice President University of Alberta Astellas Pharma Global Development, Inc. Edmonton, AB, Canada Deerfield, IL, USA Paul A. Keown MD, DSc, MBA, FACP, FASN, FRCP, Jogarao V.S. Gobburu PhD FRCPC, FRCPath, FRSC, FIBiol Professor Professor of Medicine and Director of Immunology University of Maryland School of Pharmacy Departments of Medicine and Pathology and Laboratory Baltimore, MD, USA Medicine University of British Columbia Daniel R. Goldstein PhD Vancouver, BC, Canada Associate Professor of Internal Medicine and Immunobiology Yale University School of Medicine Allan D. Kirk MD, PhD, FACS New Haven, CT, USA Professor of Surgery and Pediatrics Scientific Director, Emory Transplant Center David Hager PharmD, CNSC Emory University School of Medicine Clinical Pharmacist in Transplantation Atlanta, GA, USA University of Wisconsin Hospital and Clinics Madison, WI, USA Stuart J. Knechtle MD, PhD Professor of Surgery and Pediatrics Peter S. Heeger MD Chief, Division of Transplantation Professor of Medicine Emory University School of Medicine Division of Nephrology Atlanta, GA, USA Recanati/Miller Transplantation Institute Mount Sinai School of Medicine Fadi G. Lakkis MD New York, NY, USA Professor of Surgery and Immunology Stanley C. Jordan MD Scientific Director, Thomas E. Starzl Transplantation Institute University of Pittsburgh Professor of Pediatrics & Medicine Pittsburgh, PA, USA David Geffen School of Medicine at UCLA; Medical Director, Renal Transplant Program Mallika Lala PhD Director, Nephrology and Transplant Immunology Cedars-Sinai Medical Center Division of Pharmacometrics Los Angeles, CA, USA Office of Clinical Pharmacology Center for Drug Evaluation and Research Barry D. Kahan PhD, MD US Food and Drug Administration Silver Spring, MD, USA Emeritus Professor Division of Immunology and Organ Transplantation Richard D. Mamelok MD The University of Texas Medical School at Houston Houston, TX, USA Mamelok Consulting Palo Alto, CA, USA Joseph Kahwaji MD Kidney and Transplant Program Didier A. Mandelbrot, MD Cedars-Sinai Medical Center; Medical Director, BIDMC Living Kidney Donor Program Assistant Clincial Professor Director of Clinical Trials, The Transplant Institute, BIDMC David Geffen School of Medicine at UCLA Associate Professor of Medicine, Harvard Medical School Los Angeles, CA, USA Boston, MA, USA 00000011446688118866..IINNDDDD vviiiiii 22//11//22001122 77::4455::3311 PPMM List of Contributors ix Beata Mierzejewska MD Melanie Ruzek PhD Senior Research Scholar Principal Scientist University of Toledo College of Medicine Genzyme Corporation Toledo, OH, USA Framingham, MA, USA Michael C. Milone MD, PhD Mohamed H. Sayegh MD Assistant Professor of Pathology and Laboratory Medicine Director, Schuster Family Transplantation Research Center Associate Director, Toxicology and Therapeutic Drug Brigham and Women’ s Hospital & Children’ s Hospital Boston Monitoring Laboratory Visiting Professor of Medicine and Pediatrics Hospital of the University of Pennsylvania Harvard Medical School Philadelphia, PA, USA Boston, MA, USA; Raja N. Khuri Dean, Faculty of Medicine Martin H. Oberbarnscheidt MD, PhD Vice President of Medical Affairs Research Assistant Professor American University of Beirut Thomas E. Starzl Transplantation Institute Beirut, Lebanon University of Pittsburgh Pittsburgh, PA, USA Roger Sciammas PhD Research Associate/Assistant Professor Edward C. Parkin BS Department of Surgery/Section of Transplantation Doctoral Student, Physciological Sciences University of Chicago Research Specialist Chicago, IL, USA Center for Cellular Research Department of Surgery Leslie M.J. Shaw PhD, DABCC University of Arizona Professor of Pathology and Laboratory Medicine Tucson, AZ, USA Director, Toxicology and Therapeutic Drug Monitoring Laboratory Alice Peng MD Hospital of the University of Pennsylvania Medical Director, Kidney/Pancreas Transplant Program Philadelphia, PA, USA Program Director, Nephrology Fellowship Program Cedars-Sinai Medical Center; Swetha K. Srinivasan MD Assistant Professor of Medicine Research Fellow David Geffen School of Medicine at UCLA Department of Surgery Los Angeles, CA, USA Emory Transplantation Center Emory University Mark D. Pescovitz MD (deceased) Atlanta, GA, USA Professor of Surgery and Microbiology/Immunology Indiana University Medical Center Stanislaw M. Stepkowski DVM, PhD, DSc Indianapolis, IN, USA Professor, Departments of Medical Microbiology & Immunology and Surgery Venkateswaran C. Pillai PhD University of Toledo College of Medicine Research Associate Toledo, OH, USA Clinical Pharmacokinetics Laboratory Department of Pharmaceutical Sciences Bradford Strijack MD School of Pharmacy Renal Transplant Fellow University of Pittsburgh Division of Nephrology, Department of Medicine Pittsburgh, PA, USA University of British Columbia Vancouver, BC, Canada Horacio L. Rodriguez Rilo MD Professor of Surgery Terry B. Strom MD Director, Center for Cellular Transplantation Professor of Medicine, Harvard Medical School Associate Director Co-director, Transplant Institute at Beth Israel Deaconess Arizona Diabetes Center Medical Center Tucson, AZ, USA Boston, MA, USA 00000011446688118866..IINNDDDD iixx 22//11//22001122 77::4455::3311 PPMM x List of Contributors Mieko Toyoda PhD Flavio Vincenti MD Director, Transplant Immunology Laboratory Professor of Clinical Medicine Cedars-Sinai Medical Center; University of California Professor Transplant Service David Geffen School of Medicine at UCLA San Francisco, CA, USA Los Angeles, CA, USA Ashley A. Vo PharmD Helen L. Triemer PharmD Administrative Director Transplant Center Pharmacist Transplant Immunotherapy Program Emory Transplantation Center Cedars-Sinai Medical Center; Emory University Assistant Clinical Professor Atlanta, GA, USA David Geffen School of Medicine at UCLA Los Angeles, CA, USA Laurence A. Turka MD Professor of Medicine Richard M. Watanabe PhD Co-Director, Harvard Institute Associate Professor of Translational Immunology Division of Biostatistics Harvard Medical School Preventive Medicine and Physiology & Biophysics Co-Research Director, The Transplant Institute Keck School of Medicine Co-Chief, Division of Transplantation Immunology University of Southern California Beth Israel Deaconess Medical Center Los Angeles, CA, USA Boston, MA, USA John M. Williams PhD Marina Vardanyan MD, PhD Vice President Research Associate Transplant and Immunology Research Center for Cellular Transplantation Genzyme Corporation Department of Surgery Framingham, MA, USA University of Arizona Tucson, AZ, USA Kathryn J. Wood DPhil, FMedSci Professor of Immunology Raman Venkataramanan PhD Transplantation Research Immunology Group Professor of Pharmaceutical Sciences Nuffield Department of Surgical Sciences School of Pharmacy University of Oxford Professor of Pathology, School of Medicine John Radcliffe Hospital Associate Director TDM and Toxicology Oxford, UK Director of Clinical Pharmacokinetics Laboratory Thomas Starzl Transplantation Institute Sarah E. Yost PharmD Magee Womens Research Institute Clinical Pharmacist in Abdominal Transplantation McGowan Institute for Regenerative Medicine University of Arizona Medical Center Pittsburgh, PA, USA Tucson, AZ, USA 00000011446688118866..IINNDDDD xx 22//11//22001122 77::4455::3311 PPMM Preface The discipline of transplantation has always been is an overview of pharmacologic principles and inextricably linked to our ability to pharmacologically drug development. Part 3 concentrates on individ- modulate and suppress the immune system, while ual agents, with an emphasis on how Parts 1 and 2 at the same time avoiding infections, malignancy, intersect to produce their clinical effects. It should and other side effects. By virtue of this, transplant be noted that this part does not include all agents physicians must excel not only as diagnosticians and utilized, but rather highlights certain agents to serve surgeons, but also as pharmacologists. Perhaps in no as examples of the principles we hope to cover. other field of medicine is there such a close A tremendous amount of work went into this association between the basic field of pharmacology text and we thank the authors for their selfless and clinical practice. contributions. This textbook is not intended as an all-inclusive treatise on clinical pharmacology and immunology, Bruce Kaplan MD, PhD nor on all the agents utilized to modulate the Tucson, AZ, USA immune system. Rather, it is our hope that this text- book will serve as an introductory text to better Gilbert J. Burckart PharmD understand the general principles of pharmacologic Silver Spring, MD, USA interventions of the immune system. The book is divided into three parts. Part 1 is an Fadi G. Lakkis MD overview of transplantation immunology. Particular Pittsburgh, PA, USA attention is paid to the mechanisms by which pharmacologic agents may exert their effect. Part 2 March 2012 xi 00000011446688118888..IINNDDDD xxii 22//11//22001122 77::4499::1111 PPMM
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