Recommendations for Substitution Therapy with Immunoglobulins in Hemato-oncological Patients with Secondary Immunodeficiency – Expert Consensus According to the DELPHI Methodology
Substitution therapy with immunoglobulins is used not only for patients with primary immunodeficiencies. Below, we briefly summarize recommendations concerning hemato-oncological patients with secondary immunodeficiency.
Introduction
In hemato-oncological patients, for example with a diagnosis of chronic lymphocytic leukemia or multiple myeloma, secondary immunodeficiencies (SID) are relatively common. B-depleting therapy, among others, can contribute to the development of SID. Infections remain the main cause of morbidity and mortality in these patients. This fact emphasizes the importance of early recognition of risk levels and the potential initiation of substitution therapy with immunoglobulins. The European Medicines Agency (EMA) has approved its use in patients with SID, though recommended procedures for its initiation, interruption, and dosing remain inconsistent across different countries.
Expert Consensus According to the DELPHI Methodology and Resulting Specific Recommendations
A total of 32 experts in the fields of immunology and hemato-oncology agreed on the following recommendations concerning the diagnosis, treatment, and monitoring of hemato-oncological patients with immunoglobulin deficiency.
Three types of infections were initially defined:
- serious – requiring IV therapy, acute or prolonged hospitalization in a standard ward, or acute initiation of therapy in the ICU
- recurrent – recurring ≥ 3 infections within 12 months despite adequate anti-infective therapy
- persistent – infections not responding to adequate anti-infective therapy
Consensus was reached on measuring immunoglobulin (IgG) levels in hemato-oncological patients during the initial phase of oncological treatment. Substitution therapy with immunoglobulins should be initiated in patients during or after adequate therapy of a serious infection, or during recurrent or persistent infection if IgG levels are < 4 g/l or if the immunization test fails.
Regarding the recommended dosing of intravenous immunoglobulins (IVIG) or subcutaneous immunoglobulins (SCIG), a maintenance dose of 0.4 g/kg body weight administered every 3-4 weeks should be achieved. Experts agreed that SCIG should be offered to all hemato-oncological patients requiring substitution therapy.
Termination of therapy should be considered after at least 6 months without ongoing infection and normalization of IgG levels. These patients still require subsequent monitoring. In the case of hypogammaglobulinemia, serious, or persistent infection, substitution therapy with immunoglobulins should once again be the treatment of choice.
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Source: Jolles S., Michallet M., Agostini C. et al. An international DELPHI consensus building approach to patient assessment and use of immunoglobulin treatment for secondary immune deficiencies in hematological malignancy. EHA Library, 2020 May 14. Available at: https://library.ehaweb.org/eha/2020/eha25th/297829/michael.albert.an.international.delphi.consensus.building.approach.to.patient.html
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