Project update: September 2024
Dear VALUE-Ig investigators, collaborators, and partner organisations,
We are pleased to bring you the 3rd VALUE-Ig newsletter with a brief update on project progress.
We have been successful in various ethics applications to collect or obtain data on the use Ig and associated outcomes, and we have started data analysis. We have begun to build the VALUE-Ig hospital dataset, which we hope will be a dataset of pooled hospital data. We have received multi-site ethics approval from Alfred Health, who have also become the first hospital to contribute data. We are currently pursuing the Royal Children’s Hospital as the second site.
Given the time required to build the research team and the VALUE-Ig dataset, we have successfully applied for an extension to the grant timeline, which is now due to finish on 31st March 2026.
Research updates
Haematological malignancy
We have been analysing Victorian hospital data from the Centre for Victorian Data Linkage (CVDL) for this cohort and are developing several manuscripts for publication. In both multiple myeloma and chronic lymphocytic leukaemia, we are exploring the circumstances under which patients are hospitalised for infections and exploring why patients start Ig replacement therapy.
Myasthenia gravis (MG)
We have begun the VALUE-MG study alongside MGBase, to prospectively enrol and capture additional data on MG patients to help understand the value of Ig in this population. This is a non-interventional study designed to capture important patient reported outcome measures for patients during routine MG care. Alfred Health has recruited over 30 participants so far. Four more sites are planned to join the study, including a new site, Princess Alexandra Hospital in Brisbane. Governance procedures are underway, and we hope to begin recruitment at this site soon.
In addition, we conducted two focus group sessions with 19 MG patients, recruited with the assistance of the Myasthenia Australia Alliance, to co-design our patient preference survey. These sessions aimed to explore treatment preferences for both mild and severe flare-ups, as well as ongoing MG management. Patients shared the factors they would prioritise when selecting treatments, expressing appreciation for having multiple options. IVIg treatment was generally viewed as helpful. The discussions also highlighted key concerns about side effects and treatment outcomes, with gastrointestinal issues being the most commonly reported. Other side effects mentioned included fatigue, weight gain, depression, line infections, blood clotting risks, increased risks of skin cancer and diabetes, hair loss, bone loss, and poor sleep. Patients acknowledged the need to continually balance treatment side effects with managing their MG symptoms.
Other
The VALUE-Ig study also includes other patient cohorts including primary immunodeficiencies, solid organ transplant recipients, and patients receiving B-cell depletion therapy such as rituximab for lupus or rheumatoid arthritis. We will use the CVDL Victorian hospital data in combination with the VALUE-Ig dataset for these cohorts.
Research outputs
Congratulations to Sara Carillo De Albornoz who, as part of her PhD at the Transfusion Research Unit, has published two papers looking at Ig use in haematological malignancy.
- Carrillo De Albornoz, S., Chai, K. L., Higgins, A. M., Petrie, D., Wood, E. M., & McQuilten, Z. K. (2024). A systematic review of the cost and cost-effectiveness of immunoglobulin treatment in patients with hematological malignancies. International Journal of Technology Assessment in Health Care, 40(1), Article e32. https://doi.org/10.1017/S026646232400028X
- de Albornoz, S. C., Higgins, A. M., Petrie, D., Irving, A., Fanning, L., Weinkove, R., Crispin, P., Dendle, C., Gilbertson, M., Johnston, A., Keegan, A., Pepperell, D., Pullon, H., Reynolds, J., van Tonder, T., Trotman, J., Waters, N., Wellard, C., Weston, H., McQuilten, Z. K. (2024). Economic evaluation: immunoglobulin vs prophylactic antibiotics in hypogammaglobulinemia and hematological malignancies. Blood Advances, 8(9), 2259-2267. https://doi.org/10.1182/bloodadvances.2023012047
Dr Abby Zhang will also be presenting a poster of her work on the circumstances in which multiple myeloma patients commence Ig replacement therapy using CVDL data at Blood 2024 in Brisbane.
Summary
Various data collection exercises and preliminary analysis of Victorian hospital data are underway. The VALUE-Ig dataset now contains Alfred Health data; hopefully, a second site will follow soon. If you have any queries about the study or suggestions, please do not hesitate to contact the team at value.ig@monash.edu.
Prof Dennis Petrie
Centre for Health Economics, Monash University
On behalf of the VALUE-Ig team.