Data Demonstrate Aerius® (Desloratadine) Reduces Symptoms And Improves Quality Of Life In Patients With Persistent Allergic Rhinitis
Analyses evaluate the relationship between symptom improvement of ARIA-defined persistent allergic rhinitis and daily functioning
Warsaw, Poland – June 9, 2009 – AERIUS® (desloratadine) significantly reduces the impact of allergy symptoms on quality of life in persistent allergic rhinitis (PER) patients with a significant disease burden, according to two post hoc analyses presented for the first time today. The analyses demonstrate that there is a positive correlation between symptom relief and improvement in daily functioning after treatment with AERIUS. The results, presented in two separate poster presentations at the Congress of the European Academy of Allergology and Clinical Immunology, held in Warsaw, Poland, June 6-10, 2009, are from two separate analyses of the AERIUS Control: Clinical and Evaluative Profile of Treatment (ACCEPT) trials.
“Emerging evidence suggests that patients with persistent allergic rhinitis experience greater quality of life impairments than those with intermittent allergic rhinitis, but until now, little has been known about the relationship between symptom improvement and quality of life,” said Torsten Zuberbier, M.D., Professor of Dermatology and Allergy, University of Berlin. “In these ACCEPT trials, patients treated with desloratadine showed reduced allergy symptoms and improvements in quality of life, including improved emotion and a decrease in both disease burden and interference with daily activities.”
As many as 94 million people across Europe are affected by allergic rhinitis (or hay fever) each year.1 Previously, and now in some geographical regions, allergic rhinitis (AR) has been classified as seasonal or perennial based on the time of exposure and the nature of the allergen (outdoor or indoor). Updated Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines, however, classify allergic rhinitis as intermittent (IAR) or persistent (PER) based on the duration of the condition. According to the ARIA’s classifications, patients with PER experience symptoms lasting more than four days per week and more than four consecutive weeks per year. The ACCEPT trials are the first to evaluate an antihistamine based on the ARIA guidelines’ updated classification of AR, and they were conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN).
Impact of Total Symptom Improvement on Quality of Life
According to one analysis of the ACCEPT trials, in 355 patients with moderate-to-severe PER, those receiving AERIUS 5mg for a 12-week treatment period experienced significant improvements (P<0.004) in total symptom severity score (T5SS = nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritus, and ocular pruritus) (mean change from baseline [MCB] -3.83). In these patients, improved symptoms correlated with:
• Improvement in quality of life, including activity, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotion based on total Rhinoconjunctivitus Quality of Life Questionnaire (RQLQ) scores (MCB -1.33)
• Decrease in disease burden using Work Productivity and Activity Impairment (WPAI) questionnaire scores (MCB -19.74), which measures patient-rated symptom irritation
• Decrease in interference with activities of daily living (MCB -0.64)
These findings show positive correlations according to calculation of Pearson correlation coefficients (r) between the mean change from baseline of the total symptom severity score and the mean changes from baseline in improvement on quality of life based on the total RQLQ (r=0.53), decrease in disease burden using the WPAI score (r=0.46) and in interference with activities of daily living (r=0.67) (P<0.0001 for all).
Impact of Reduced Congestion on Sleep Quality and Daily Functioning
A separate analysis of the ACCEPT trials evaluated the correlation between improvements in congestion and sleep quality in patients with PER taking AERIUS. The findings show that patients taking AERIUS experienced 24-hour symptom relief, and reductions in congestion scores correlated with improved sleep and daily activity. Specifically, patients taking AERIUS showed significant (P<0.05) improvement in the morning (MCB -0.56), evening prior (MCB -0.74) and morning prior (MCB -0.71) congestion scores. Among these patients, the analysis also showed significant improvement in:
• Interference with sleep (MCB –0.52)
• Interference with activities of daily living (MCB -0.64)
• Total improvement on quality of life based on the Rhinoconjunctivitus Quality of Life Questionnaire (RQLQ), sleep, and activity domain scores (MCB –1.33, –1.23, –1.35, respectively; P<0.0001 for all)
From these findings, positive correlations were observed between congestion scores and the mean changes from baseline in interference with sleep (r≥0.57) and activities of daily living (r≥0.55) (P<0.0001 for all). Significant correlations were also found for congestion and improvement on quality of life based on the RQLQ total (r≥0.44), sleep (r≥0.40), and activity (r≥0.42) domain scores (P<0.0001 for all).
About ACCEPT
The ACCEPT (AERIUS Control: Clinical and Evaluative Profile of Treatment) clinical trials consisted of two multi-national, prospective, randomized, placebo-controlled studies of AERIUS 5 mg in patients 12 years of age or older with ARIA-defined AR. The trials evaluated the efficacy, impact on quality of life, productivity and pharmacoeconomics in patients with intermittent allergic rhinitis (IAR) in one study and in patients with PER in an additional study. Studies were conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN), a clinical research network of leading European research centers, through an unrestricted grant from Schering-Plough. Participating countries in the ACCEPT trials included Canada, France, Germany, Italy, Spain, Denmark, Sweden, Belgium, the Netherlands, Hungary, Greece, Finland, Portugal, Turkey and Russia.
About AERIUS
AERIUS (desloratadine) is a nonsedating antihistamine for the treatment of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria, or hives. AERIUS Tablets is approved to treat these symptoms in patients 12 years of age and older. AERIUS Orodispersible Tablets 2.5 mg and 5 mg are approved to treat these symptoms in patients 6 years of age and older.2 AERIUS Syrup and AERIUS Oral Solution are both approved to treat these symptoms in patients 1 year of age and older.2
The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache.2 In clinical trials in a pediatric population (children aged 6 months through 11 years), the overall incidence of adverse events in children 2 through 11 years of age was similar for the AERIUS syrup and placebo groups.2 In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea, fever and insomnia.2
Schering-Plough markets desloratadine under the brand names AERIUS, AZOMYR and NEOCLARITYN in Europe, where it is available as a prescription medicine, and also as prescription CLARINEX® in the United States. AERIUS [AZOMYR] [NEOCLARITYN] builds upon Schering-Plough’s heritage as a leader in discovery and development.
About Schering-Plough Corporation
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
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References:
1. http://www.wrongdiagnosis.com/p/pollen_allergy/stats-country.htm.Statistics for Northern, Western, Central, Eastern, Southwestern, Southern and Southeastern Europe combined.
2. AERIUS (summary of product characteristics) Schering Corporation.
