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Asthma Treatment With Omalizumab (Xolair®), New Data Shows Benefits

New data analyses presented at the European Respiratory Society (ERS) Annual Congress in Vienna show that long-term treatment with omalizumab (Xolair®) significantly improves a range of outcomes for people with severe persistent allergic asthma, a chronic condition affecting an estimated 14,315 people in the UK4. Asthma can be a devastating condition, causing an average of three deaths in the UK every day, 90% of which are preventable with optimal management5.

The data, from three different analyses, each looking at real-life data from UK centres, show that from initiation of treatment with omalizumab GP visits can be reduced by up to 100%, hospital bed days by up to 97.8%, admissions to ICU by up to 95.2%, general hospital admissions by up to 87.9% and A&E visits by up to 82.1%1,2,3. The mean duration of omalizumab treatment in each of the three analyses was 798 days (range: 90-1,569), 1,052 days (range: 112-4,217) and 1,318 days (range: 238-4,217)1,2,3.

Dr Dinesh Saralaya, Consultant Respiratory Physician, Bradford Teaching Hospitals NHS Foundation Trust and one of the investigators involved in the analyses said, “For the first time we are able to demonstrate that long-term treatment with omalizumab delivers sustained, real-life benefits for people with severe persistent allergic asthma. These data show just how effective omalizumab can be at slashing ICU admissions, A&E visits and other dependencies on healthcare services, allowing people with severe persistent allergic asthma to enjoy a significantly improved quality of life and reducing the burden on the limited resources of the NHS.”

Government strategy aims to reduce unscheduled care by minimising avoidable attendances at A&E departments and reducing emergency admissions and length of stay in hospital.

In addition to reductions in healthcare service utilisation omalizumab was also shown to reduce the mean maintenance dose of oral corticosteroids by up to 68.3% and improve quality of life by a clinically significant 1.6 points in the patient-reported Asthma Quality of Life Questionnaire (AQLQ)2,3. Oral corticosteroid therapy is often used to treat these patients when all else has failed, but it is associated with many long-term side effects such as weight gain, hypertension, osteoporosis and depression6,7.

Commenting on the data, Professor Neil Barnes, Professor of Respiratory Medicine, London Chest Hospital, Barts Health NHS Trust said, “By reducing the dependence on oral corticosteroids and significantly improving quality of life for people with severe persistent allergic asthma, omalizumab meets a clear unmet medical need and thus has an important role to play in the management of this condition. These data show that physicians are using omalizumab both effectively and responsibly.”

Omalizumab is currently recommended by the National Institute for Health and Clinical Excellence (NICE) as an add-on therapy to optimised standard therapy, in adults and adolescents (12 years and older) with severe unstable disease8.

People with uncontrolled severe persistent allergic asthma are at high risk of severe exacerbations and asthma-related mortality and represent the greatest unmet medical need among the asthmatic population today9. Of the 14,315 people in the UK with severe persistent allergic asthma it is estimated that that omalizumab may benefit around 30% (approximately 4,295 people) of them4.

About the studies

The data detailed in this release relate to three analyses that were presented at the European Respiratory Society (ERS) Annual Congress in Vienna on Sunday 2nd September between 8:30AM and 10:30AM local time.

The first analysis was a retrospective review of 51 patients with severe persistent allergic (IgE-mediated) asthma in a real-life clinical setting at five UK centres. Patients had received omalizumab for ≥16 weeks. 41 were responders and included in the analyses. They were aged 17-69 years of age. 37 patients had data on baseline oral corticosteroid use (OCS) use and 30 of these (81.1%) were taking OCS1.

The second analysis was a retrospective review of 93 patients with severe persistent allergic (IgE-mediated) asthma in a real-life clinical setting using pooled data from four UK centres. Patients had received omalizumab for ≥16 weeks. 76 were considered responders and included in the analyses. They were aged 14-74 years of age. 67.1% of patients were taking OCS prior to omalizumab2.

The third analysis was a retrospective review of patients with severe persistent allergic (IgE-mediated) asthma in a real-life clinical setting using pooled data from three UK centres. 50 patients (85%) were classified as responders and were included in the analysis. They were aged 18-74 years of age. At baseline, 32 of 47 of patients (68.1%) were receiving OCS (three of the 50 responders were missing OCS data)3.

In all three analyses, clinically significant improvements in quality of life were seen regardless of whether patients were, or were not, receiving maintenance OCS at baseline.

About omalizumab

Omalizumab is a humanised monoclonal antibody that blocks the action of immunoglobulin E (IgE), an antibody involved in the underlying mechanism of allergic asthma. By targeting IgE, omalizumab can prevent the onset of symptoms, such as shortness of breath and wheezing, in severely affected people9,10. Eligible patients must have a positive skin or blood test for a perennial aero-allergen, an FEV1< 80% (if over 12 years old) as well as frequent day time symptoms and/or night time awakenings11. It is administered as a subcutaneous (under the skin) injection every two to four weeks. Doses and frequency are determined by levels of total IgE in the blood, measured before the start of treatment, and will vary according to patient body weight (kg)11.

The majority of side effects of omalizumab are mild or moderate in severity. In adult and adolescent patients (aged 12 and over) the most commonly reported adverse events were injection site reactions, including injection site pain, swelling, itching and redness of the skin, and headaches11. In clinical trials in children (6 and less than 12 years), the most commonly reported adverse reactions suspected of being related to omalizumab were headaches, fever and upper abdominal pain11.

In the UK, omalizumab is currently indicated as add-on therapy to improve asthma control in adults and children (≥6 years) with severe persistent allergic asthma who remain uncontrolled despite daily high-dose inhaled steroids plus a long-acting inhaled β2-agonist11.

Source

1 Masoli M et al. “Omalizumab improves lung function in severe persistent allergic (IgE-mediated) asthma patients: pooled data from five UK centres”. Presented at the European Respiratory Society Annual Congress, -5 September 2012, Vienna, Austria

2 Britton M et al. “Real-life effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: pooled data from four UK centres”. Presented at the European Respiratory Society Annual Congress, -5 September 2012, Vienna, Austria

3 Britton M et al. “Long-tem effectiveness of omalizumab in patients with severe persistent allergic (IgE-mediated) asthma: pooled data from three UK centres”. Presented at the European Respiratory Society Annual Congress, -5 September 2012, Vienna, Austria

4 Novartis Data on File

5 Asthma UK. Facts for journalists. Available here. Last accessed: August 2012

6 Busse W et al. “Effect of omalizumab on the need for rescue systemic corticosteroid treatment in patients with moderate-to severe persistent IgE-mediated allergic asthma: a pooled analysis”. Current Medical Research and Opinion. 2009;23(10):2379–2386

7 Walsh L et al. ”Adverse effects of oral corticosteroids in relation to dose in patients with lung disease. Thorax”. 2001;56:279-84

8 National Institute for Health and Clinical Excellence. Final appraisal determination – omalizumab for severe persistent allergic asthma in adults and adolescents (12 years and older). Issue date: November 2007. Available here. Last accessed: August 2012

9 Korn S et al. “Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany”. Respiratory Medicine. 2009;103:1725-1731

10 Humbert et al. “Benefits of omalizumab as ad-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE”. Allergy. 2005;60:309-316

11 Xolair SPC. Available here. Last accessed: August 2012

Source: Novartis