One sublingual tablet taken once daily—without titration

GRASTEK dissolves rapidly under the tongue; do not swallow for at least 1 minute

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5-year adult study (n=634)

(3 years on treatment, 2 years off) assessed sustained effect in patients aged 18 through 65 years

Approximately 80% of patients completing the study were sensitized to grass pollen, as well as additional allergens.

GRASTEK demonstrated significant decreases in TCS throughout the grass pollen season in 3 treatment years. This effect was sustained for the first grass pollen season year after treatment was discontinued, but was not sustained during the second year as the upper limit of 95% CI for TCS (–37.1%, –6.3%) exceeded –10% (FDA criteria); the mean decrease was 22.7% for GRASTEK (n=137) vs placebo (n=104)
STUDY DESIGN: A 5-year, randomized, double-blind, parallel-group, European, multicenter, placebo-controlled, allergy immunotherapy study of 634 adult patients evaluated the sustained efficacy of GRASTEK. GRASTEK or placebo was administered as a daily sublingual tablet 4-8 months prior to GPS, continuing treatment for a total of 3 consecutive years and then observed for 2 subsequent years without treatment. Patients in both arms of the study were additionally permitted to take symptom-relieving allergy medications as needed. Both treatment groups were balanced with regard to baseline characteristics. Patients ranged from 18 through 65 years of age (mean age=34 years), were 59% male and 96% white, 2% Asian, and 1% African American, had a history of grass pollen-induced allergic rhinitis with or without conjunctivitis diagnosed by a physician and received treatment during 2 previous GPS, and had sensitivity to Timothy grass as determined by positive skin prick and IgE tests. Approximately 24% of patients at baseline had asthma, and FEV1 needed to be ≥70% predicted. Approximately 80% of patients completing the study were sensitized to other allergens in addition to grass pollen. Reasons for exclusion included clinical history of allergic rhinitis due to non-grass pollen allergens overlapping GPS. The coprimary endpoints were average DSS and DMS, measured for the entire GPS at each of the 5 years. DSS measured 6 symptoms (runny nose, stuffy nose, sneezing, itchy nose, gritty/itchy eyes, and watery eyes) on a scale of 0 (none) to 3 (severe), for a maximum daily total of 18. DMS measured use of standard open-label allergy medications, with oral antihistamine scored as 6 points/tablet, ocular antihistamine as 1.5 points/drop, steroid nasal spray as 1 point/puff, and oral steroid as 1.6 points/tablet, for a maximum daily total of 36. Relative differences (% decreases) were calculated as follows: (GRASTEK–placebo)/placebo x 100 Entire season was defined as the first day of 3 consecutive days with a grass pollen count of ≥10 grains/m3, through to the last day of the last occurrence of 3 consecutive days with a grass pollen count of ≥10 grains/m3. Study extended from 1 to 5 years (site closures, patient unwillingness to participate beyond 1 year). FEV1=forced expiratory volume in 1 second.
STUDY DESIGN: An approximately 24-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled, allergy immunotherapy study of 344 pediatric patients evaluated the efficacy of GRASTEK. GRASTEK (n=149) or placebo (n=158) was administered as a daily sublingual tablet approximately 16 weeks prior to and continuing through GPS. Patients in both arms of the study were additionally permitted to take symptom-relieving allergy medications as needed. Both treatment groups were balanced with regard to baseline characteristics. Patients ranged from 5 through 17 years of age (mean age=12.3 years), were 65% male and 88% white, 7% African American, and 2% Asian, had a history of grass pollen-induced allergic rhinitis with or without conjunctivitis diagnosed by a physician and received treatment the previous GPS, and had sensitivity to Timothy grass as determined by positive skin prick and IgE tests. Twenty-six percent had mild, intermittent asthma, and FEV1 needed to be ≥70% predicted. Eighty-nine percent were sensitized to other allergens in addition to grass pollen, including weed, tree, pet dander, dust mites, and mold. Patients with a clinical history of symptomatic allergies to non-grass allergens that required treatment during GPS and patients with severe asthma were excluded from the study. The primary endpoint was TCS, which is the averaged sum of DSS and DMS, during the first entire GPS. DSS measured 6 symptoms (runny nose, stuffy nose, sneezing, itchy nose, gritty/itchy eyes, and watery eyes) on a scale of 0 (none) to 3 (severe), for a maximum daily total of 18. DMS measured use of standard open-label allergy medications, with oral antihistamine tablet or syrup scored as 6 points/dose, ocular antihistamine as 1.5 points/drop, steroid nasal spray as 4 points/spray for patients aged 5–11 years and 2 points/spray for patients aged 12–17 years, and oral steroid as 1.6 points/tablet and 1.6 x 2 points/tablet for Day 2 onward, for a maximum daily total of 36. Relative differences (% decreases) were calculated as follows: (GRASTEK–placebo)/placebo x 100 Estimated group means are reported and difference relative to placebo is based on estimated group means.

Studies evaluated GRASTEK vs placebo. Patients in both treatment arms were additionally permitted to take symptom-relieving allergy medications as needed.

Safety and tolerability profile for GRASTEK

Onset And Duration Of Most Common Local Application Site
Adverse Reactions: Pooled Analysis Of Adult Patients

In the pooled analysis of 6 adult studies 67% (n=1111/1669) of adult patients taking GRASTEK had an adverse reaction

Onset And Duration Of Most Common Local Application Site
Adverse Reactions: Pooled Analysis Of Pediatric Patients

In the pooled analysis of 6 adult studies 67% (n=1111/1669) of adult patients taking GRASTEK had an adverse reaction
Duration reflects number of days that an adverse reaction occurred and does not reflect duration of an individual event. In one clinical study of adult patients, duration of individual events was typically 5 to 10 minutes after tablet intake.

Prescribing Information

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