Supporting evidence-based guidance for immunoglobulin replacement therapy

28/08/26

Immunoglobulin replacement therapy (IgRT) plays an important role in the prevention of infections in patients with secondary immunodeficiency, i.e. a reduced ability of the immune system to fight infections resulting from an underlying disease (e.g. leukaemia) or medical treatment (e.g. chemotherapy). As immunoglobulins are produced from human plasma, their availability depends on a sufficient and sustainable supply of plasma donations. Ensuring appropriate use of these plasma-derived medical products is therefore essential, both in order to optimize patient care and to safeguard access for patients who are most likely to benefit. 

To support evidence-based clinical practice, the European Haematology Association is developing a guideline on the use of IgRT in patients with secondary immunodeficiencies. As part of this project, CEBaP is conducting a series of systematic reviews to determine the optimal use of IgRT in secondary antibody deficiency. The reviews will address:

• Indications for initiation and discontinuation of IgRT;
• Dosing strategies; 
• Target serum immunoglobulin G trough levels during treatment.

The full review protocol is available in PROSPERO. 

In addition to conducting the evidence reviews, CEBaP will support the guideline development process by applying internationally recognized methodologies, including:

• The GRADE approach to assess the certainty of evidence and support the formulation of recommendations;
• The Delphi consensus methodology to achieve expert agreement in areas where evidence is limited or uncertain.

By combining robust evidence synthesis with structured expert consensus, this initiative aims to support more consistent, transparent, and patient-centred decision-making in clinical practice. The resulting guideline will help clinicians make informed decisions on the optimal use of immunoglobulin replacement therapy for patients with secondary immunodeficiency.