1. University of Lincoln & Hull York Medical School, UK;2. Paul‐Ehrlich Institute, Langen, Germany;3. EDQM, Council of Europe, Strasbourg, France;4. Centre for Chronic Immunodeficiency (CCI), Freiburg, Germany;5. Members of the Kreuth Ig‐Working Group (WG): Marie‐Emmanuelle Behr‐Gross, EDQM, Strasbourg, France Jose Drabwell, Chair IPOPI Board, England, UK Martha Eibl, Immunologische Tagesklinik, Vienna, Austria Basil Golding, Associate Director for Medical Affairs, US Food and Drug Administration, Silver Spring, MD, USA Jacqueline Kerr, Paul Ehrlich Institute, Langen, Germany Taco Kuijpers, Department of Pediatric Hematology, Immunology & Infectious disease, Academic Medical Center (AMC), University of Amsterdam, Amsterdam, Netherlands Hans‐Hartmut Peter, Centre for Chronic Immunodeficiency, Freiburg, Germany Isabella Quinti, Department of Immunology, Sapienza, Roma Ivo N. van Schaik, Department of Neurology, AMC, University of Amsterdam, Amsterdam, Netherlands Anna Sediva, University Hospital Motol, Prague, Czech Republic W A Carrock Sewell, University of Lincoln & Hull York Medical School, UK Mikko Sepp?nen, University Central Hospital, Helsinki, Finland Peter J. Sp?th, Lecturer em., Institute of Pharmacology, University of Berne, Berne, Switzerland
Abstract:
The use of immunoglobulin (Ig) preparations (intravenous, IVIg, subcutaneous, SCIg) for replacement and immunomodulation therapy worldwide has tripled in the past 20 years and represents an ever‐increasing cost factor for healthcare organizations. The limited access to the starting material of this essential medicinal product is currently the driving force for human plasma collection. Increasing awareness and improved diagnosis of human primary immunodeficiencies and a broadening of immunomodulatory indications are responsible for this development, and on a longer run might lead to plasma supply shortages. Consensus recommendations for the optimal use of Ig in clinical practice, including priority rankings for the most urgent indications, are therefore urgently needed. During a recent meeting in Kreuth, Germany, expert nominees from 36 Council of Europe states, together with colleagues from observer countries and regulatory agencies came up with this consensus statement.
