ck test to 5-grass pollen extract and positive in vitro testing for timothy grass-specific serum IgE. For the US study, subjects had a positive skin prick test to Timothy grass pollen extract.
With the exception of those with mild intermittent asthma, patients with asthma were excluded. Approximately 16% had asthma at baseline and 65% were polysensitized (i.e., sensitized to the 5-grass pollen allergen extract and at least one other unrelated allergen). Overall, the mean age of study participants was 28 years and 56% were male.
Natural Field Studies
In the natural field studies, efficacy of ORALAIR as immunotherapy to treat symptoms of allergic rhinoconjunctivitis due to the grass pollens included in ORALAIR was assessed via daily recording of symptoms and rescue medication use. The daily Combined Score (CS, range: 0-3) equally weights symptoms and rescue medication use. The daily Rhinoconjunctivitis Total Symptom Score (RTSS, range 0-18) is the total of the six individual symptom scores (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each graded by participants on a 0 (no symptoms) to 3 (severe symptoms) scale. The daily Rescue Medication Score (RMS, range 0-3) grades the intake of rescue medication as 0 = absent, 1 = antihistamine, 2 = nasal corticosteroid, 3 = oral corticosteroid. In case of multiple medications, the higher score is retained. Least Squares (LS) means are within-group means adjusted for the covariates in the statistical models (i.e., analyses of covariance for average scores and linear mixed models with repeated measures for daily scores). The Relative Difference is the LS mean difference between ORALAIR and Placebo divided by the LS mean of Placebo, expressed as a percentage.
US Study
In this study, 473 adults aged 18 through 65 years received ORALAIR or placebo, starting approximately four months prior to the expected onset of the grass-pollen season and continuing for the duration of the pollen season. The results of the analysis of the daily Combined Score (CS), daily Rhinoconjunctivitis Total Symptom Score (RTSS), and daily Rescue Medication Score (RMS) are summarized in Table 4.
Table 4. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), and Daily Rescue Medication Score (RMS) during the Grass Pollen Period (US study)
LS: Least Squares
Primary efficacy analysis
Secondary efficacy analysis
European Study
In this study, adults aged 18 to 45 years received one of 3 different doses of 5-grass pollen extract sublingual tablet or placebo. A total of 311 subjects received ORALAIR or placebo starting approximately 4 months prior to the expected onset of the grass pollen season and continuing for the duration of the grass pollen season. The results of the analysis of the daily CS, daily RTSS and daily RMS for ORALAIR (300 IR) are shown in Table 5.
Table 5. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), and Daily Rescue Medication Score (RMS) during the Grass Pollen Period (European study)
LS: Least Squares
Long Term Study
In this study, adults received ORALAIR or placebo according to two different treatment regimens. A total of 426 subjects received ORALAIR or placebo starting approximately 4 months prior to the grass pollen season and continuing for the entire season. Subjects were treated for three consecutive grass pollen seasons (Year 1 to Year 3). The primary eva luation was the Year 3 pollen period. Participa |
