Project update: March 2024

Dear VALUE-Ig investigators, collaborators, and partner organisations,

We are pleased to bring you the 2nd VALUE-Ig newsletter with a brief update on project progress. We have been applying for ethics approvals to obtain data on the use Ig and associated outcomes and started some preliminary data analysis.

The data requirements of the ideal dataset to answer research questions regarding the economic value of Ig are high. To our knowledge, there are no readily available datasets in Australia that capture all the important aspects needed to answer such questions. We have several ongoing data initiatives to fill these gaps.

To that end, we are planning to build the VALUE-Ig hospital dataset, which we hope will be a dataset of pooled hospital data. We have applied for multi-site ethics approval from Alfred Health, who will also be the first hospital to contribute data. The VALUE-Ig dataset will not only capture data on procedures performed in hospitals, but importantly also blood bank, laboratory (e.g., Ig levels) and pharmacy (e.g., chemotherapy) data along with details on future hospitalisations for these patients.

Cohort 1: Acquired hypogammaglobulinaemia secondary to haematological malignancy or stem cell transplantation (HGG + HM/SCT)

For Cohort 1, HGG + HM/SCT we currently have access to Victorian hospital data from the Centre for Victorian Data Linkage (CVDL). We are currently performing preliminary analyses on the relationship between chemotherapy, Ig replacement and serious infections in these patients.

Cohort 2: Acquired hypogammaglobulinaemia not secondary to haematological malignancy or stem cell transplantation (HGG – HM/SCT)

Cohort 2, HGG – HM/SCT is a diverse patient group including solid organ transplant recipients, those receiving B-cell depletion therapy such as rituximab for lupus or rheumatoid arthritis, and patients with Goods syndrome. We have submitted a second application to the CVDL to access Victorian hospital data for these patients. We are also developing an analysis plan to use the ANZDATA kidney transplant registry to investigate the relationship between Ig use and transplant rejection.

Cohort 3: Primary immunodeficiencies (PID)

For Cohort 3, Primary Immunodeficiencies we will be utilising the VALUE-Ig dataset and Victorian hospital data from the CVDL.

Cohort 4: Myasthenia gravis (MG)

Patients in Cohort 4, MG we have received ethics approval for a sub-study alongside MGBase, a national MG registry, to prospectively enrol and capture additional data on MG patients to help understand the value of Ig in this population. We are aiming to have our first site initiation in March and to begin recruiting patients immediately afterwards.

Summary

Various data collection exercises and preliminary analysis of Victorian hospital data are underway.

If you have any queries about the study or suggestions, please do not hesitate to contact the team at value.ig@monash.edu.