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Clinical Focus Rebecca H ISSUE 14 | MARCH 2011 AUTHOR Jordan Orange, M.D., Ph.D. EDITOR R. Michael Blaese, M.D. IDF MEDICAL ADVISORY COMMITTEE Clinical Focus Rebecca H. Buckley, M.D., Chair Duke University School of Medicine, Durham, NC Zuhair Ballas, M.D. on Primar y I mmunodeficiencies University of Iowa, Iowa City, IA Mark Ballow, M.D. State University of New York, Buffalo, NY R. Michael Blaese, M.D. Consulting Medical Director IDF, Towson, MD Francisco Bonilla, M.D., Ph.D. Children’s Hospital, Boston, MA Mary Ellen Conley, M.D. St. Jude Children’s Research Hospital, Memphis, TN Charlotte Cunningham-Rundles, M.D., Ph.D. Mt. Sinai Medical Center, New York, NY Alexandra H. Filipovich, M.D. Cincinnati Children’s Hospital, Cincinnati, OH Thomas Fleisher, M.D. National Institutes of Health, Bethesda, MD Ramsay Fuleihan, M.D. Children’s Memorial Hospital, Chicago, IL Erwin Gelfand, M.D. National Jewish Medical and Research Center, Denver, CO Vivian Hernandez-Trujillo, M.D. Miami Children's Hospital, Miami, FL Steven Holland, M.D. National Institutes of Health, Bethesda, MD Richard Hong, M.D. Biomosaics, Burlington, VT Richard B. Johnston, Jr., M.D. Clinical Update in University of Colorado School of Medicine, Denver, CO Howard M. Lederman M.D., Ph.D. Johns Hopkins Hospital, Baltimore, MD Immunoglobulin Harry L. Malech, M.D. National Institutes of Health, Bethesda, MD Stephen Miles, M.D. All Seasons Allergy, Asthma & Immunology, The Woodlands, TX Therapy for Primary Luigi Notarangelo, M.D. Children's Hospital and Harvard Medical School, Boston, MA Hans D. Ochs, M.D. Immunodeficiency Children’s Hospital, Seattle, WA Jordan Orange, M.D., Ph.D. Children’s Hospital of Philadelphia, Philadelphia, PA Jennifer M. Puck, M.D. Diseases University of California, San Francisco, San Francisco, CA John Routes, M.D. Children's Hospital of Wisconsin, Milwaukee, WI William T. Shearer, M.D., Ph.D. Texas Children’s Hospital, Houston, TX E. Richard Stiehm, M.D. UCLA School of Medicine, Los Angeles, CA Kathleen Sullivan, M.D., Ph.D. Children’s Hospital of Philadelphia, Philadelphia, PA Troy Torgerson, M.D., Ph.D. University of Washington, Seattle, WA Jerry Winkelstein, M.D. Baltimore, MD This publication was made possible by an educational grant from ImmuneDisease.com This book contains general medical information which cannot be applied safely to any individual case. Medical knowledge and practice can change rapidly. Therefore, this book should not be used as a substitute for professional medical advice. Copyright 2011 by Immune Deficiency Foundation, USA. Readers may redistribute this article to other individuals for non-commercial use, provided that the text, html codes, and this notice remain intact and unaltered in any way. The Clinical Focus on Clinical Update in Immunoglobulin Therapy for Primary Immunodeficiency Diseases may not be resold, reprinted or redistributed for compensation of any kind without prior written permission from Immune Deficiency Foundation. If you have any questions about permission, please contact: Immune Deficiency Foundation, 40 West Chesapeake Avenue, Suite 308, Towson, MD 21204, USA; or by telephone at 1-800-296-4433. www.primaryimmune.org Immune Deficiency Foundation: Clinical Focus / 1 Clinical Update in Immunoglobulin Therapy for Primary Immunodeficiency Diseases Jordan S. Orange, M.D., Ph.D. relatively crude preparation of immunoglobulin via the Associate Professor of Pediatrics subcutaneous route. He documented restoration of serum immunoglobulin levels and described a clinical benefit for the University of Pennsylvania School of Medicine patient. In the almost 60 years that have elapsed since this initial Division of Allergy and Immunology publication, an entire field of PIDD has evolved as well as The Children’s Hospital of Philadelphia tremendous innovation in the treatment of PIDD patients. 3615 Civic Center Blvd – ARC 907A PIDD presently represents a compilation of greater than 150 Philadelphia PA 19104 different diseases according to the International Union of Immunological Societies (IUIS) expert panel review (2). The list of diseases characterized as a PIDD has expanded substantially in recent years and will most certainly continue to expand in years to Abstract come. Presently, more than 60 of the IUIS categorized PIDD Immunoglobulin therapy represents a life saving intervention for affect the production of antibodies. In considering the replacement many patients with primary immunodeficiency disease (PIDD). of antibodies therapeutically, however, it is impractical to have 60 While this therapy has existed and has been in use for more than different guidelines and approaches for using immunoglobulin in 60 years, the preparations themselves and our understanding of PIDD. This is especially true as the number of individual antibody how they are applied to patients to enhance outcomes has deficiency diagnoses continues to expand even further. For this continually evolved. This update will focus upon the currently reason, it is logical as we move into the future, to utilize a smaller available immunoglobulin preparations and how they can be used number of phenotypic categories that will account for and to optimize patient outcomes. encompass the individual PIDD diagnoses affecting antibody production. It has been proposed to consider the antibody History and Diagnoses deficiencies according to 4 phenotypic categories (3). These are Primary antibody deficiencies as a PIDD are those in which the presented in Table 1 and rely upon three basic phenotypes: 1) major impact is upon the production and maintenance of quality presence of B cells; 2) quantity of antibody; and 3) quality of antibodies against specific antigens. These disorders have their antibody. This in essence represents an expanded approach roots in several places. Perhaps most importantly is the original previously published by a working group of the American Academy publication of Bruton in the Journal Pediatrics in 1952 (1). Here of Allergy, Asthma and Immunology (AAAAI) (4). Since the first case of agammaglobulinemia was described and along immunoglobulin replacement therapy is with IgG, the with it the reconstitution of immunoglobulin in the patient through consideration of antibody in this present and the previous immunoglobulin therapy. In this report, Bruton provided a schema is limited to IgG. TABLE 1 Adapted from Stiehm, Orange, Ballow, et. al. Adv. Pediatr. 2010 57:185-218 CATEGORY B CELLS IgG QUANTITY IgG QUALITY DIAGNOSTIC EXAMPLES (antigen-specific antibody) • Agammaglobulinemia I Absent Absent Absent • SCID • Hyper IgM II Present Low Low • CVID • NEMO deficiency (subset) • Specific Antibody Deficiency III Present Normal Low • NEMO deficiency (subset) • Subclass deficiency with specific antibody defect • Transient hypogammaglobulinemia of infancy IVª Present Low Normal • Primary hypogammaglobulinemia ªDocumentation of specific antibody function should be performed in these individuals and if impaired should prompt their being considered for a category II diagnosis. 2 / Immune Deficiency Foundation: Clinical Focus The first phenotypic category is when a patient lacks B cells, which defects within this group that may allow them to be placed into the of course are required for antibody production. In this case, there third category. They may also represent patients “in evolution” who is inappropriate antibody quantity and quality. Examples include might eventually develop detectable humoral abnormalities. This, agammaglobulinemia and severe combined immunodeficiency unfortunately, is likely to be consistent with the long diagnostic (SCID), both of which can be due to a variety of distinct genetic delays found in certain diagnoses such as CVID (8). This potential causes, including some cases that have yet to be genetically category also might contain patients with defects elsewhere in the defined. immune system, such as in the innate immune system (i.e., IRAK4 deficiency), who are in need of more intensive investigation. The second category is when B cells are present, but both antibody quality and quantity are abnormal. Examples here include common With regards to the appropriateness of providing immunoglobulin variable immunodeficiency (CVID) and the hyper-IgM syndrome. replacement therapy to patients with humoral PIDD in consideration Again, there are multiple distinct genetic causes for these, but CVID of the abovementioned phenotypic categories, the evidence in the great majority remains without a genetic mechanism. Since it underlying these and recommendations for doing so is the topic of is hypothesized that CVID, like many of the antibody deficiencies, other articles and documents (reviewed in (4, 9)). There are, results from multifactorial and multiple individual genetic etiologies, however, certain considerations that should be respected and are it is unlikely that there will ever be a singular genetic mechanism. worth pointing out here. In particular, there are some diagnoses for For this reason, the use of phenotypic categories remains relevant. which it is imperative to supply immunoglobulin replacement immediately upon diagnosis and not stop therapy for any additional The third category is when B cells and the quantity of antibody are diagnostic purposes. These would include SCID, normal, but the quality is not. Examples here include the agammaglobulinemia, and hyper-IgM. A single cessation of therapy phenotypic diagnosis referred to as specific antibody deficiency for others may be appropriate for diagnostic confirmation, but this (SAD), or
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