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54 Plasma KCE Reports 120 3.2.2.3 Immuno-hematological diseases A summary of evidence findings and levels of evidence for IG use is presented in Table 21. Primary immune deficiencies Primary immunodeficiency disorders (PID) result from intrinsic defects of the immune system, in contrast to immune disorders that are secondary to infection, chemotherapy or immunosuppressive therapy. Individuals with PID are prone to recurrent bacterial infections, typically in respiratory and gastro-intestinal tracts, or protozoal, fungal and viral infections, of varying severity. Deficiencies of various components of the immune system have been identified, and more than 200 different PID are currently recognized by the WHO. In Europe, the PID requiring IG replacement that are the most commonly diagnosed are: the common variable immunodeficiency (CVID) - revealed at adulthood, X-linked agammaglobulinemia (XLA), other agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiency, hyper-IgM syndromes and severe hypogammaglobulinemia with recurrent and severe bacterial infections. 24 In most of the cases with severe antibody deficiency (IgG
KCE Reports 120 Plasma 55 • IG reduces the incidence and severity of infection in patients with agammaglobulinemia and severe hypo-gammaglobulinemia. • Effectiveness of IG in milder hypogammaglobulinemia, IgG subclass deficiency and impaired polysaccharide responsiveness is unclear. • The route of administration (IV or SC) does not influence treatment effectiveness. Secondary immune deficiencies In many patients, the immune deficiency is a direct consequence of a decreased antibody production due to cancers of the haematopoietic system, such as multiple myeloma or chronic lymphocytic leukaemia, cytotoxic chemotherapy, immunosuppressive therapy to prevent transplants rejection, very low weight etc. The effectiveness of IG in treating the conditions leading to secondary immune deficiency varies per pathology. It has only been well studied for specific pathologies, such as multiple myeloma, chronic lymphocytic leukaemia and stem cell transplants (see below). For hypo-gammaglobulinemia related to other diseases or drug therapy, no evidence on the benefit of IG treatment was found. However, most guidelines recommend the use of IG – besides antimicrobial prophylaxis – to decrease the risk of infection in cases with the same criteria than those set for PID requiring IG supplementation: IgG levels under reference range and severe or recurrent bacterial infections that are unresponsive to prophylactic antibiotics etc. 17, 22 . Multiple myeloma and chronic lymphocytic leukaemia Multiple myeloma (MM) and chronic lymphocytic leukaemia (CLL) are rare proliferative disorders that lead to a higher incidence of serious bacterial infections, such as pneumonias and urinary tract infections. Factors underlying the increased susceptibility to infections are many and complex. A major factor is the decreased capacity to produce potent immunoglobulins, often reflected by a certain degree of hypogammaglobulinemia observed in the majority of patients. In MM, the immunodeficiency is mainly caused by abnormal Ig production and impairment of the primary immune response. 41 Infections and its consequences (including renal failure) are the major cause of morbidity and mortality in both diseases. Up to 65% of CLL patients die from infection-related events and MM cases have a fatality rate of 30%. Many treatment strategies exist for MM and CLL; IG is mainly used as prophylactic agent to prevent infections, mostly in recurrent life threatening infections. 42 A Cochrane review updated in 2009 included ten RCT involving MM or CLL patients with hypogammaglobulinemia and recurrent infections, and the meta-analysis combined studies from both diseases. 43 It showed that no benefit of IG could be demonstrated in terms of mortality, but IG significantly decreased the risk of clinically documented infections by 51% (RR 0.49, 95% CI 0.39-0.61), and significantly reduced the occurrence of microbiologically documented infections as compared to controls (RR 0.71, 95% CI 0.53-0.95). Authors concluded that IG use may be considered in MM and CLL patients with hypogammaglobulinemia and recurrent infections, for the reduction of clinically documented infections. Another systematic review, conducted by the same group, included nine of the 10 RCT involving CLL and MM patients, and presented similar findings and conclusions. 44 A 2005 systematic review on the cost of disease included cost-effectiveness studies. 45 It only found one cost effectiveness study on IG, published in 1991, thus excluded from this review. 46 IG significantly decreased documented infections in CLL and MM patients but had no impact on mortality. IG is considered in patients with documented hypogammaglobulinemia and recurrent infections.
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KCE Reports 120B Plasma i PRÉFACE
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KCE Reports 120B Plasma iii MÉTHOD
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KCE Reports 120 Plasma 121 APPENDIX
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73. Financement du programme de soi
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