New Data Demonstrate Efficacy Of Aerius(R) (Desloratadine) In Reducing Allergy Symptoms In Patients With Intermittent Allergic Rhinitis

Main Category: Allergy
Also Included In: Ear, Nose and Throat
Article Date: 11 Jun 2008 - 4:00 PDT

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New data presented at the XXVII Congress of the European Academy of Allergology and Clinical Immunology (EAACI) in Barcelona, Spain, demonstrate AERIUS® (desloratadine) significantly reduces allergy symptoms, including nasal congestion, sneezing, rhinorrhea, nasal pruritus and ocular pruritus, in patients with intermittent allergic rhinitis (IAR) who experience symptoms lasting less than four days per week or less than four weeks per year. The results are part of the AERIUS Control: Clinical and Evaluative Profile of Treatment (ACCEPT) trials, which were conducted in collaboration with the Global Allergy and Asthma European Network (GA2LEN) and evaluated the safety and efficacy of AERIUS for the treatment of allergic rhinitis (AR), as defined by the updated Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines.

According to the study in patients with IAR, those receiving AERIUS 5 mg for a 15-day treatment period experienced significant reduction in total symptom severity score from baseline versus placebo (-3.01 vs. -2.13; P<0.001). Additionally, patients receiving AERIUS experienced improvement in symptoms as early as the first day of treatment (P=0.001) and lasting for the full 24-hour dosing period across the entire study (P<0.001).

"These data show that AERIUS is an effective and well-tolerated first-line treatment for intermittent allergic rhinitis," said Jean Bousquet, Department of Pneumonology, University Hospital, Montpellier, France. "The ARIA guidelines distinguish the symptomatic classification of IAR, which is a new way of thinking about and diagnosing allergy symptoms, and now the ACCEPT studies have confirmed which options are effective in treating this new classification of allergic rhinitis."

The study also evaluated the effects of AERIUS in reducing nasal congestion and other individual symptom scores in patients with IAR. Compared to patients taking placebo, patients with IAR taking AERIUS experienced a significantly greater improvement from baseline in average nasal congestion scores (-0.43 vs. -0.56, respectively; p=0.013). In addition, patients taking AERIUS experienced significantly lower nasal congestion at the end of the first 24-hour dosing period (P≤0.001), versus patients taking placebo. The data also show AERIUS significantly reduced additional IAR symptoms including rhinorrhea, sneezing, eye itching and nasal itching at the end of the 24-hour dosing period on the second day (P≤0.035) and over the rest of the 15-day treatment period (P≤0.036).

An additional analysis from the ACCEPT trial assessed the ability of patients with IAR to work, go to school or accomplish general daily activities while taking AERIUS, as defined by the Work Productivity Activity Impairment-Allergy Specific (WPAI-AS) questionnaire. Compared to patients with IAR taking placebo, the study found patients with IAR taking AERIUS experienced a significant reduction in percent overall work-related impairment, compared to patients taking placebo (-24.7 percent vs. 1.6 percent, respectively; P=0.002).

Traditionally, AR has been classified as seasonal or perennial based on the time of exposure and the nature of the allergen (outdoor or indoor). The updated ARIA guidelines classify allergic rhinitis as intermittent (IAR) or persistent (PER) based on the duration of the condition. According to the ARIA's classifications, patients with IAR experience symptoms lasting less than four days per week or less than four weeks per year. The ACCEPT trials are the first to evaluate an antihistamine based on the ARIA guidelines' updated classification of AR.

"The ACCEPT study also marked the first time that the Global Allergy and Asthma European Network, in cooperation with Schering-Plough, has utilized the pan-EU allergen panel for testing, said Torsten Zuberbier, Department of Dermatology and Allergy, Universitatsmedizin Berlin, Berlin, Germany. "With this study, we are making critical steps to standardize the diagnosis and treatment of allergic rhinitis throughout Europe for the benefit of patients and clinical research."

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 IAR in one study and also evaluated 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.

The IAR ACCEPT trial assessed the effect of AERIUS 5 mg versus placebo administered once daily for 15 days. A total of 547 patients were randomized with 276 patients receiving AERIUS and 271 receiving placebo. All patients were required to have ARIA-defined IAR for at least two years that was symptomatic at baseline, and patients also had to demonstrate a positive skin-prick test to at least one relevant allergen, preferably using the GA²LEN allergen panel.

The primary endpoint of the ACCEPT trials was the mean change from baseline in the daily average of morning and evening (prior 12-hours) five symptom scores (T5SS); in the IAR study this was averaged over days 1 to 15. Secondary endpoints included safety, the impact of AERIUS treatment on important disease measures, including the Rhinoconjunctivitis Quality of Life Questionnaire, individual symptom scores, the symptom severity visual analog scale (VAS) and effects on rhinitis-impaired sleep, daily activities and productivity.

About Allergic Rhinitis

As many as 94 million people across Europe are affected by allergic rhinitis (or hay fever) each year.1 Symptoms may include sneezing, congestion, runny nose, and itchy or watery eyes.2 Symptoms of allergic rhinitis can have an impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

Survey data show that symptoms are most severe in the morning, and about two-thirds of respondents reported that morning suffering affects the rest of the day.3 Mornings can be an especially difficult time for all allergy sufferers in terms of allergic triggers because pollen concentrations are usually highest between 5 a.m. and 10 a.m. In addition, if a pet is sleeping in the bed, exposure to their dander during the night may account for the increased prevalence and severity of morning allergy symptoms. People with allergies also should shower before going to bed to rinse off any pollen or pet dander that may have collected in their hair or on their body during the day.

The survey also showed that even though allergies are frequently a self-diagnosed condition, patients rely on medical experts to help properly manage their symptoms.3

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.4 AERIUS Syrup and AERIUS Oral Solution are both approved to treat these symptoms in patients 1 year of age and older.4 AERINAZE (desloratadine 2.5 mg/ pseudoephedrine 120 mg) Modified-Release Tablets is approved to treat these symptoms when accompanied by nasal congestion, in patients 12 years of age and older.5

The most common side effects in adults and adolescents with allergic rhinitis and CIU were fatigue, dry mouth and headache.4 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.4 In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhea, fever and insomnia.4

Research shows AERIUS provides powerful morning symptom relief for seasonal allergic rhinitis patients. In a study of 346 people with moderate-to-severe seasonal allergic rhinitis, patients receiving AERIUS experienced significant improvement in morning total symptom scores (which includes both nasal and non-nasal symptoms) versus placebo.6 AERIUS offers demonstrated efficacy at the end of the dosing interval.4

Schering-Plough markets desloratadine under the brand names AERIUS, AZOMYR and NEOCLARITYN in Europe, where it is available either as a prescription or non-prescription pharmacy-only medicine, and 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 http://www.schering-plough.com.

Schering-Plough Disclosure Notice

The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to potential market for AERIUS. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item IA. "Risk Factors" in Schering-Plough's 2008 10-Q.

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. Management of Allergic Rhinitis and Its Impact on Asthma: Pocket Guide. 2001.

3. "Understanding the Dynamics Surrounding Allergy Suffering and Treatment" Forbes Consulting Group. 2005.

4. AERIUS (summary of product characteristics) Schering Corporation.

5. AERINAZE (summary of product characteristics). Schering Corporation.

6. Meltzer EO, Prenner MB, Nayak A, and the Desloratadine Study Group. Efficacy and tolerability of once-daily 5mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons. Clin Drug Invest. 2001; 21:25-32.

Schering-Plough Corporation