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Xyzal (Levocetirizine) Shows Significant Improvements In Quality Of Life For Patients With Persistent Allergic Rhinitis: Presented at EAACI

First ever trial into treatment of newly-defined disease subtype

PARIS, FRANCE -- June 9, 2003 -- New data presented at the 22^nd European Academy of Allergology and Clinical Immunology (EAACI), 7 - 11 June 2003, in Paris, France, today show that Xyzal® (levocetirizine) significantly improves patients' quality of life by 47.5% when compared to placebo, in patients with persistent allergic rhinitis (PER). Quality of life was assessed using a universally accepted, disease-specific method - the Rhinitis Quality of Life Questionnaire (RQLQ). Significant improvements in quality of life were also seen with Xyzal® using a more generic scoring method, the SF-36 Physical Component Score (p<0.001).

The XPERTTM study data also show that Xyzal® significantly improved symptoms of PER when compared to placebo over the first 4 weeks of the study (5.43 ± 0.15 vs. 6.56 ± 0.15). Symptom improvement - which was seen on most individual symptoms as early as the first week - was sustained over the 6 months of the study in patients treated with Xyzal® (p<0.001). Efficacy was assessed using Total Five Symptom Score (T5SS).

These new Quality of Life and clinical data are from the XPERTTM (Xyzal in Persistent Rhinitis Trial) study, which looked at long-term treatment with Xyzal® of patients with PER. XPERTTM is the first large study investigating treatment of PER since it was newly-defined in the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines.

Allergic rhinitis was previously subdivided into seasonal, perennial and occupational, based on time of exposure to allergens. ARIA believed this subdivision to be less than satisfactory, and hence advocated a new classification of allergic rhinitis in new guidelines. The new classification is based on duration and severity, and is subdivided into "intermittent" or "persistent" and into "mild" or "moderate-severe". A diagnosis of PER is made when symptoms last for more than 4 days a week and for more than 4 weeks, suggesting chronic inflammation caused by persistent allergen exposure.

Commenting on the data, Professor G. Walter Canonica, one of the authors of the XPERTTM trial, and Director of Allergy and Respiratory Disease at Università degli Studi di Genova, Italy, said: "For the first time, the XPERTTM study has given us a comprehensive investigation into PER - a newly-defined disease subtype. The symptoms of PER are chronic and have a huge impact on a patient's quality of life. The XPERTTM study confirms that long-term treatment with Xyzal® is not only effective at treating the symptoms of persistent allergic rhinitis, but can also significantly improve a patient's quality of life. The study also suggests that continuous treatment for PER is required. This is of particular relevance to people who are suffering chronic symptoms at the height of the hayfever season, and to people whose symptoms will continue well into the autumn due to persistent house dust mite allergy."

The XPERTTM trial also showed that fewer patients treated with Xyzal® suffered from a co-morbid disease, such as asthma and upper respiratory tract infections, compared to patients treated with placebo (54% vs. 71% respectively). There were fewer incidences of asthma (7% vs. 13%) and upper respiratory tract infections (42% vs. 52%) in patients treated with Xyzal® than in patients who received placebo. This reduced co-morbidity resulted in the reduced use of medical resources over the duration of the study, and hence economic savings.

Further pharmacoeconomic evaluation revealed that treatment of PER with Xyzal® led to fewer working days being lost as a result of uncontrolled symptoms, and to a reduction in loss of productivity at work. Loss of productivity at work and in performing usual daily activities due to allergic rhinitis or comorbidity was halved (-59% and -52% respectively) with the active treatment, relative to placebo.1

During the 6 months of the study, 16.5% of patients in the placebo group stopped their treatment due to lack of efficacy, compared to only 7.6% in the Xyzal® group. Also in that time, there was little difference between the Xyzal® and placebo groups in the number of adverse events. In the placebo group, 13.6% of patients experienced at least one adverse event, compared to 20.5% of patients in the Xyzal® group.

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References:
Bachert C, et al. XPERTTM: Levocetirizine long-term treatment in patients suffering from persistent allergic rhinitis. Poster presentation at EAACI Congress, Paris. June 2003.
Juniper EF, Guyatt GH, Andersson B, Ferrie PJ. Comparison of powder and aerosolized budesonide in perennial rhinitis: validation of rhinitis quality of life questionnaire. Annals Allergy 1993; 70: 225-230 Management of allergic rhinitis and its impact on asthma. A pocket guide for Physicians and Nurses. 2001. Visit ARIA at www.whiar.com


SOURCE: Ketchum

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