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Australian Xolair Registry (AXR)

Home Registries Australian Xolair Registry (AXR)

The Australian Xolair Registry (AXR) is an investigator-initiated, observational post-marketing surveillance registry of patients with severe allergic asthma undergoing omalizumab (Xolair) therapy managed by the Australasian Severe Asthma network (ASAN).

AXR recruitment is now closed and the database is a source for ongoing analyses.

Purposes of the AXR:

Enabled clinicians to document eligibility for omalizumab commencement and continuation,
Documented adverse events from treatment with omalizumab and other medications (such as oral corticosteroids), and
Reported on the magnitude of the problem of severe allergic asthma, characteristics of this population and their management.

Patient enrolment

Clinicians were invited to enrol patients with severe allergic asthma who underwent assessment for eligibility and commencement of omalizumab treatment through the Pharmaceutical Benefits Scheme (PBS) during 2011 to June 2014. The patients underwent an assessment at registration and were followed prospectively for 2 years.

Severe allergic asthma in Australia - finding from the AXR

The AXR has provided useful information regarding the use and effectiveness of omalizumab in real-world severe allergic asthma in Australia. A total of 192 patients were registered across 21 clinics and 180 of these patients were approved for treatment. 83% of the patients responded to the initial 6 months of treatment (Gibson et al. 2016).

Key AXR findings:

The disease burden in AXR patients is high and these patients have extensive respiratory and non-respiratory co-morbidities, such as rhinitis (48% of patients), nasal polyps (15%), obesity (45%) and cardiovascular disease (23%). Symptomatic response to treatment is high and includes improvement in asthma control, asthma-related quality of life and lung function. Encouragingly, these improvements occur despite the presence of co-morbidities (Gibson et al. 2016).
Omalizumab treatment improves asthma control and health-related quality of life in patients with severe allergic asthma and overlapping/associated chronic obstructive pulmonary disease (COPD). However, improvements in lung function are observed only in patients without overlapping COPD (Maltby et al. 2017).
Over 30% of patients in the AXR are above the recommended Australian dosing range and received a ceiling dose of omalizumab (determined by total serum IgE and body weight). Patients above the dosing range had a similar response to patients within range, including improved asthma control, asthma-related quality of life and lung function (Hew et al. 2016). In countries such as the United States, patients above the standard dosing range are ineligible for treatment, whilst an extending dosing schedule has been adopted in the European Union.
- Omalizumab treatment over 24 months reduces symptoms, exacerbation frequency and oral corticosteroid (OCS) use in severe allergic asthma with fungal sensitisation, an important complication in severe asthma (Wark et al. 2020).
Clinical remission is achieved in a subset of patients receiving biologic treatments. After 12 months of omalizumab treatment, clinical remission was achieved in 23% of patients (Thomas et al. 2023)

Appropriate human research ethics committee and research governance approvals were in place for the conduct of this registry. The AXR was supported by Novartis Pharmaceuticals Australia Pty Ltd as an investigator-sponsored study.