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Polyvalent human immunoglobulins used for therapeutic purposes and administered by the intravenous route (IVIG) were initially used as replacement therapy for patients with primary immunodeficiencies, but are increasingly being employed for the treatment of certain dysimmune and inflammatory disorders, some of which are dermatological diseases. However, their use is currently only validated for a limited number of diseases having been studied in controlled trials (dermatomyositis, Kawasaki disease) with the results for other dermatological conditions deriving from non-controlled studies or small series. Treatment with IVIGs is generally restricted to rare or severe diseases in limited numbers of patients presenting heterogeneous characteristics, which excludes the performance of controlled studies. The first-line use of IVIGs is also limited because of their high cost.
Intravenous immunoglobulins are prepared from the plasma of a large pool of individuals (3000-10000 donors) according to different processes depending on the manufacturer, but production always results in pure (degree of purity above 99.9 per cent), non-aggregated immunoglobulin G (IgG) concentrate that may be lyophilised or not and that retains all its functional properties. Several techniques are used to guarantee optimal product safety: the donors are carefully selected, the blood is preventively screened for all known transmissible infectious agents, modern viral inactivation techniques are applied and finally, the finished product is subjected to pharmacological and biological characterisation tests.
Thanks to the above preparation procedures and compliance with WHO criteria and European guidelines , the therapeutic use of IVIGs is currently associated with very few risks or adverse events.
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