AXR Newsletter_Jan 2014 edition


• As we enter the 3rd year of the Australian Xolair Registry we have collected data from 149 participants who are from 17 participating sites around Australia.
• 18 sites have ethics approval, 3 more sites are still waiting for ethics approval also 3 more sites are in the process of ethics submission
• Please visit our web site for more information:
• The AXR eDatabase has been upgraded to make it easier for data entry, quality control and to avoid unnecessary confusion for the data entry person.
• A new SAE reporting process has been developed to simplify the data entry and SAE submission. We now have a system generated SAE report that will help monitoring, reporting and analysing SAEs.

Status report:

• To date, a total of 149 participants have enrolled in the registry.
• As many as 130 patients have commenced Xolair treatment and at initial application 6 PBS application were rejected (ineligible) and approx. 13 patients are awaiting for the PBS approval.
• A total of 13 patients have either completed or are currently in the 5th cycle of PBS subsidised treatment and a few participants have either entered or are in 5th cycle onwards up to 7th cycle (each cycle is approx. 6 month).
• As many as 20 participants who have stopped treatment from 2nd to 5th cycle , and no one ceased treatment from 6th cycle onwards so far.
• SAEs: 24 more SAEs have been reported since 2012. These events occurred after patients were enrolled in the AXR, and include asthma exacerbations which required hospitalisation and one Xolair treatment related SAE(anaphylaxis) and one death which didnt appear to be Xolair related.

Feedback from the participating sites:

• The AXR eDatabase is very useful for data management, patient clinical management and clinical research.
• The AXR provides great features e.g. offering prepopulated PBS application form at clinic settings, which is easy for data entry anywhere, by any study personnel, and for clinical management monitoring (dosage, treatment log and medication log, patient visit reminder etc), and SAE reporting.
• The AXR is very useful in terms of consolidating expertise for severe asthma although it is time consuming for some administering roles (dealing with patients, review eligibilities, paper works for submission etc) but not so much with the database itself;
• There are some patients whose IgE levels are very high and who receive the maximum recommended dose. It would be of interest to compare the treatment outcome with other patients whose IgE is within the dosing table recommendaitons.
• the AXR helps to manage to patient better such as: monitoring the treatment, compliance, medication adherence, AE/SAE, and Treatment log to monitor Xolair treatment,
• Re PBS form and grandfathered patients: to collect the information for PBS application forms required and Non PBS form related are quite time consuming.

The message from the AXR management:

• Please enter as much information as you can ESPECIALLY for those CRFs which contain a “green bar” (PBS required information) and, a prepopulated PBS application form and ACQ calculation sheet can then be printed out from the AXR for submission.
• Always complete the omalizumab log as soon as data is entered even if PBS application is "pending" as this is the important information for the system generated report.
• Patients’ data can be entered retrospectively ie. Visit 1 (baseline) and up to whichever the current visit is and, the information for pre-baseline visit (more than 6 month “old” PBS subsidized treatment) can also be entered and the section is located between the sections of Visit 5 and 6
• Some other useful information may also be completed if the information is available e.g. Triggers and comorbidity, Spirometry and AQLQ
• Please continue to enter information for each F/U visit including updating the individual F/U visit section in the “Omalizumab log” once a visit is completed. ALSO, continue collecting F/U visit information even if Xolair treatment was ceased and write down the reason in the Omalizumab log in that visit section.
• If the patients’ application was rejected by PBS/Medicare, please provide the reason in the Log for that particular visit.
• Please make sure to report SAE by faxing the prepopulated Form to 1800 650 493 and any hospitalised asthma exacerbation is a SAE.

What is next?

• Launch another “campaign” to encourage more recruitment prior to the recruitment closing date which is on 30/06/2014. The Aim is to recruit 200 participants by the end of June 2014.
• Complete the 1st year data report and present at TSANZ in April this year
• Continue ongoing data collection and data quality control process in preparing the 2nd comprehensive data report in which includes ongoing visits information
• Continue to provide effective assistance to sites for both data entry and data queries
• Continue to improve the database to make it easier for data entry and data reporting
• Organise another PIs meeting during the TSANZ conference in April

Upcoming events:

1. the details for the poster presentation at TSANZ conference
Title: Severe Refractory Allergic Asthma In Australia: The Australian Xolair Registry (AXR)
Session Date: 07/04/2014
Session: SIG Posters - Asthma and Allergy
Session Time (viewing and poster discussion session): 1530 – 1730
Location: Poster Hall

2. Severe Asthma Symposium at TSANZ conference:
1030‐1200 TUESDAY, 8 APRIL 2014
Concurrent Symposium 6: Severe Asthma
1. Introduction ‐ NAC: Newly revised clinical guidelines for asthma
2. What's new in the clinical management of severe asthma? The severe asthma task
force and disease registers
3. Role of the innate immune system in regulating steroid resistant inflammation and
airways hyperreactivity
4. The role of smooth muscle in severe asthma resistance

3. Combined PIs meeting (AXR & SAWD studies) at 7:00-8:30am on Tuesday,
08/04/2014 at TSANZ (room TBC) during which both the Xolair register (AXR
and Severe Asthma Web-based Database (SAWD) study will be discussed.

Contact details:

For further information and if you are interested in participating in the AXR please contact:
Project Manager: Dr Michael Guo
T +61 2 9114 0410; F +61 2 9114 0014; M +61 417 066 099;
E; W