Mepolizumab is a Pharmaceutical Benefits Scheme (PBS)-approved add-on biologic treatment for patients with severe eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP).
Registries for biologic treatments can provide useful insight into the characteristics of patients most likely to benefit from treatment in real-world clinical practice. Registries provide evidence which both complements and extends the evidence obtained through pivotal randomised controlled trials
The Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP) is an investigator-initiated database study designed to monitor and report on real-world outcomes in patients receiving mepolizumab treatment for their severe CRSwNP.
This multi-centre, observational post-marketing surveillance registry monitors the use, effectiveness and safety of mepolizumab in patients with CRSwNP.
Note: Mepolizumab is prescribed by the local site as part of routine practice.
The AMR-CRSwNP uses a centralised, telehealth-based data collection model:
- Participating sites are asked to identify and refer potential participants to the Central Registry team (located in Newcastle and Sydney, NSW).
- The Central Registry team completes participant enrolment and data collection prior to the participant commencing mepolizumab treatment.
- The Central Registry Team also collects follow-up data 1 year after treatment commencement.
Information collected for the registry includes demographic and relevant clinical data, as well as patient-reported outcomes. Key clinical information required for the initiation and continuation of mepolizumab treatment is also accessed from sites and recorded in the registry.
Specialist ENT, immunology, allergy and respiratory clinics from around Australia can be involved. If you or your clinic are interested in being involved as a site, please contact:
Mr Rejoy Sabin Thomas
Research Registry Officer
College of Health, Medicine and Wellbeing, University of Newcastle
Email: AMR-Study@newcastle.edu.au OR rejoy.sabinthomas@newcastle.edu.au
Phone: 02 4042 0998
The AMR-CRSwNP is sponsored by The University of Newcastle and supported by the GSK Investigator-Sponsored Studies Scheme. Human Research Ethics approval is in place for this registry.