NEW expert consensus guidelines on the use of immunoglobulin replacement therapy (IgRT) in patients with haematological malignancy and secondary antibody deficiencies (SAD) were recently published in the European Journal of Haematology.
The publication, sponsored by Octapharma, marks the first pan-European consensus guidance on the use of IgRT in patients with hypogammaglobulinaemia secondary to haematological malignancies and aims to support harmonisation of clinical practice across Europe.
Octapharma has a longstanding commitment to improving the management of patients with secondary immunodeficiencies (SID) and in 2020 launched PRO-SID, a phase III clinical trial investigating primary infection prophylaxis with intravenous immunoglobulin (IVIg) in patients with chronic lymphocytic leukaemia, CLL. These efforts address the need for both robust clinical data and unified guidance on managing infection risk in patients with SID. The absence of guidance leaves patients at risk.
SID is a common complication in patients with haematological malignancies such as CLL and multiple myeloma, MM. Up to 85% of CLL patients and up to 83% of patients with smouldering MM have low immunoglobulin levels, which leaves patients more susceptible to infections 1,2 . Infections are the likely cause of death in 22% of patients with MM and up to 50% of patients with CLL 3,4 . IgRT is effective at reducing the risk of infections in patients with haematological malignancies 5.
In 2019, the EMA approved the expanded use of IVIg in patients with SID 6 . However, detailed European guidelines on the use of IgRT in patients with haematological malignancies and SAD were lacking. Differences in treatment approaches to reduce the infection burden remain significant across Europe, including different strategies for the initiation, dosing and discontinuation of IgRT.
Stephen Jolles, lead author of the publication and Professor at the Immunodeficiency Centre for Wales in Cardiff, UK, commented: “Developing consensus guidelines for the use of IgRT in secondary antibody deficiency, SAD, aims to address a major need for treatment recommendations for patients with haematological malignancies and SAD.
IgRT can reduce morbidity and mortality in a selected group of these patients and it is important that physicians have consistent guidance on defining this group and managing infection risk.”
A Task Force of eight experts in immunology and haemato-oncology developed statements on key aspects of IgRT, which were reviewed by a panel of 32 European experts. This Delphi consensus exercise developed clear recommendations for SAD due to haematological malignancies such as: measurement of IgG levels at the beginning of anti-cancer treatment; initiation of IgRT in patients who have received appropriate anti-infective therapy during or after a single severe infection or during recurrent or persistent infections when IgG levels are <4 g/l or if test immunization has failed; initiation of IgRT with a minimum IgG dose of 0.4 g/kg body weight every 3-4 weeks or stopping IgRT after at least 6 months without infections and concomitant evidence of immunological recovery.
The 21 consensus statements emphasise the importance of IgRT for patients with SAD who experience severe, recurrent or persistent infections and provide guidance on initiation, dosing and discontinuation of IgRT, as well as the measurement of IgG levels and the use of subcutaneous immunoglobulin, SCIg, therapy.
– Mar. 3, 2021 @ 17:14 GMT |