Paediatric study shows benefits of XYZAL(reg)* (levocetirizine) in allergic rhinitis over entire pollen season

A daily dose of the potent and highly selective H1-antihistamine,1 Xyzal (levocetirizine), can control seasonal allergic rhinitis (SAR) symptoms in children throughout the pollen season. Results of a six week, placebo controlled trial of 177 children aged 6 to 12 years with SAR are reported in the leading medical publication, Pediatric Allergy and Immunology1.

In the study, Xyzal 5mg once daily provided sustained relief from the four key symptoms of SAR - sneezing, rhinorrhoea, nasal and ocular pruritus - as measured by the Total Four Symptom Score (T4SS). Nasal congestion was also improved, as was quality of life, and parents, children and investigators consistently recorded improvement in their overall assessment of the disease.

Professor Jacques de Blic, from the Hopital des Enfants Malades, in Paris, France, pointed out that the six week treatment duration of the study was designed not only to cover the seasonal peak for SAR, but also to evaluate the safety and consistency of the efficacy of Xyzal, over the whole season.

"These findings indicate that levocetirizine can be effectively used in children on a daily basis during the entire pollen season. No other antihistamine has been studied over such a long time period in children," he said.

Significantly greater improvements in rhinitis symptom score were seen with Xyzal than with placebo over the first two, four and the entire six weeks of the study (p<0.001). The relative improvement over the first two weeks with Xyzal was 94.1% greater than with placebo.

Xyzal relieved nasal congestion throughout the study, reaching a maximum effect during week 3 of the study, when the relative improvement over placebo was 77.5%.

A greater improvement in Health-Related Quality of Life, as measured by PRQLQ (Paediatric Rhinoconjunctivitis Quality of Life Questionnaire), was also seen throughout the study with Xyzal. After two weeks of treatment, PRQLQ scores in children treated with Xyzal had improved considerably compared to those treated with placebo (0.85 over baseline, compared with 0.51) and these improvements were maintained at all time points during the study.

Xyzal was well tolerated throughout the study and no clinically meaningful differences in adverse events were reported between the Xyzal and placebo groups.

"This study demonstrates that levocetirizine is well tolerated in children when used on a daily basis and is efficacious in reducing the symptoms of SAR (including nasal congestion) in children aged 6 to 12 years. It also confirms the benefit of continuous treatment of SAR in children, throughout the pollen season, with a potent antihistamine to ensure good overall symptom control and increased quality of life," concluded Professor de Blic.

*XYZAL is a registered trademark of the UCB Group. Please consult your national product information as the trademark as well as the prescribing information may differ from one country to the other.

-- Allergic rhinitis is a common inflammatory condition of the upper airways induced by exposure of the nasal membranes to allergens. It is characterised by symptoms such as itchy and runny nose, watery and itching eyes, sneezing and nasal congestion. Allergic rhinitis has a significant impact on quality of life2,3,4 and is frequently associated with other pathological conditions such as asthma.5,6,7 It is estimated to affect 10-30% of adults and 40% children.8,9

-- In Europe, Xyzal is one of the most recent antihistamines indicated for the symptomatic treatment of allergic rhinitis (including persistent rhinitis) and chronic idiopathic urticaria in adults and children over six years ( please consult your national product information as the trademark as well as the prescribing information may differ from one country to the other) . Xyzal is available as a 5mg tablet. Xyzal has been shown to produce a significant effect on the reduction of allergic rhinitis symptoms10,11,12 including nasal congestion in clinical and pharmacological studies.10,11 In addition, in Switzerland, Xyzal drops are indicated for the treatment of seasonal allergic rhinitis in children over two years and in Germany, Xyzal drops are indicated for the treatment of allergic rhinitis and chronic idiopathic urticaria in children over two years.

-- UCB ( www.ucb-group.com ) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB key products are Keppra(reg) (antiepileptic), Xyzal(reg) and Zyrtec(reg) (antiallergics), Nootropil(reg) (cerebral function regulator), Tussionex(reg) (antitussive) and Metadate(reg) / Equasym XL(reg) (attention-deficit/hyperactivity disorder). UCB employs over 8,000 people operating in over 40 countries and achieved revenues of ВЈ2.1 billion (including net sales, royalties, and fees) and an operating profit before amortisation (EBITA) of ВЈ389 million in 2004 (pro-forma IFRS excluding the specialty chemicals activities, divested in February 2005). UCB is listed on Euronext Brussels with a market capitalization of approximately ВЈ5.5 billion.

References:

1 de Blic J, Wahn U, Bi llard E et al. Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy and Immunol 2005. Online publication: 6th Apr 2005. http://www.blackwell-synergy.com/links/doi/10.1111/j.1399-3038.2005.00216.x/full/

2 Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991; 21:77-83.

3 Kremer B, Klimek L, Bullinger M et al. Generic or disease specific quality of life scales to characterise health status in allergic rhinitis? Allergy 2001; 56:957-963.

4 Bousquet J, Bullinger M, Fayol C et al. Assessment of quality of life in patient with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J Allergy Clin Immunol 1994; 94:182-188.

5 Leynaert B, Neukirch F, Demoly P et al. Epidemiologic evidence for asthma and rhinitis co-morbidity. J Allergy Clin Immunol 2000; 106:S201-S205.

6 Leynaert B, Bousquet J, Neukirch C et al. Perennial rhinitis: An independent risk factor for asthma in nonatopic subjects: Results from the European Community Respiratory Health Survey. J Allergy Clin Immunol 1999; 104:301-304.

7 Lundback B. Epidemiology of rhinitis and asthma. Clin Exp Allergy 1998; 28 Suppl 2:3-10.

8 Wright AL, Holberg CJ, Martinez FD et al. Epidemiology of physician-diagnosed allergic rhinitis in childhood. Pediatrics 1994; 94:895-901.

9 American Academy of Allergy, Asthma and Immunology. The Allergy Report, Volume 1: Overview of Allergic Diseases; pub 2000. Milwaukee, WI.

10 Day JH, Briscoe MP, Rafeiro E, Ratz JD. Comparative Clinical Efficacy, Onset and Duration of Action of Levocetirizine and Desloratadine for Symptoms of Seasonal Allergic Rhinitis in Subjects Evaluated in the Environmental Exposure Unit (EEU). Int J Clin Pract 2004; 58(2):109-118.

11 Potter PC. Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitised to house dust mites. Allergy 2003; 58:893-899.

12 Bachert C et al. XPERT(reg): Levocetirizine long term treatment in patients suffering from Persistent Allergic Rhinitis. Allergy 2003; 58:77 (Abstract 239).

For further information, please contact:

Bily Kuo
UCB
Tel.: +32 (0) 2 559 93 21
Email: bily.kuo@UCB-Group.com

Alexandra Gould
ATHENA Medical PR
Tel.: +44 (0)20 8956 22 27
Email: alexandra@athenamedicalpr.com

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