Saturday
November 5
SESSION ONE
8:25 – 8:45
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INTRAVENOUS IMMUNOGLOBULIN THERAPY: PAST, PRESENT AND FUTURE
Dr. Neil H. Shear
P. Régine Mydlarski1, Lidia Cosentino2, Vincent Ho3, Neil H. Shear4
1 Division of Dermatology, Department of Medicine, University of Calgary, Calgary, AB
2 Bayer HealthCare, Biological Products, Toronto, ON
3 Division of Dermatology, University of British Columbia, Vancouver, BC
4 Division of Dermatology, Sunnybrook and Women’s College Health Sciences Centre, Toronto, ON
History:
Immunoglobulin therapy was introduced in the 1950’s for the treatment of X-linked agammaglobulinemia. It is currently licensed in Canada for the treatment of primary and secondary immunodeficiency diseases, allogeneic bone marrow transplantation, B-cell chronic lymphocytic leukemia, pediatric HIV infection, Kawasaki disease, and idiopathic thrombocytopenic purpura. In addition, IVIG has been used in a variety of other immune-mediated indications including transplantation medicine and autoimmune and inflammatory diseases. Due to IVIGs immune-regulatory effects, several attempts have been made to use IVIG therapy in various skin diseases. The best accepted of those are toxic epidermal necrolysis and pemphigus vulgaris (and related diseases).
Different products:
IVIG is a concentrated preparation of pooled polyclonal human antibodies obtained from thousands of healthy donors. The large number of plasma donors contributing to the plasma pool provides IVIG preparations with a complete collection of antibodies directed against non-self and self-antigens. IVIG is composed largely of monomeric IgG, with small amounts of IgA and trace amounts of IgM. Several manufacturers of fractionated blood products dominate the IVIG supply market worldwide. Currently 4 licensed IVIG products are provided by Canadian Blood Services (CBS) and Héma-Québec: Gammagard S/D, and Iveegam (both manufactured by Baxter); 10% CBS/Héma-Québec IVIG (manufactured by Bayer from Canadian plasma), Gamunex™10% (manufactured by Bayer). In 2005, Bayer is supplying approximately 87% of Canada’s IVIG. The company introduced IVIG in the early 1980’s and has played a leading role in setting worldwide industry standards in the preparation of plasma for IVIG production, including donor screening, plasma procurement, plasma testing, process control, and quality assurance procedures. The newest product Gamunex is produced using caprylate viral inactivation and column chromatography. The Gamunex process requires significantly fewer steps, has a 70% shorter processing time, and produces a more purified final product compared with current products. Gamunex may be safely given at much faster rates, having the potential to reduce the patient’s infusion time up to 50%.
Canadian consensus:
Long-term systemic corticosteroids and/or immunosuppressive agents represent conventional therapy for many immune-mediated skin diseases. Unfortunately, these medications are associated with significant toxicities. Though these drugs are effective in the management of various skin diseases, a subset of patients with recalcitrant disease require an alternative treatment modality. In such cases, other therapies, including IVIG has been used to control active disease unresponsive to conventional therapy. Although in most cases, high dose IVIG is used in conjunction with corticosteroids and/or immunosuppressive agents.
We report on a consensus among Canadian dermatologists regarding the appropriate use of IVIG in dermatological disease. Emphasis has been placed on the following indications: pemphigus vulgaris (PV), pemphigus foliaceus (PF), mucous membrane pemphigoid (MMP), bullous pemphigoid (BP), epidermolysis bullosa acquisita (EBA) and toxic epidermal necrolysis (TEN). After critically evaluating published data and drawing on clinical experience, algorithms for the treatment of PV, PF, BP, EBA and MMP were developed.
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