Recommended Topic Related To:

Ragwitek

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Ragwitek

CLINICAL PHARMACOLOGY

Mechanism Of Action

The precise mechanisms of action of allergen immunotherapy are not known.

Clinical Studies

The efficacy of RAGWITEK in the treatment of ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, was investigated in two double-blind, placebo-controlled clinical trials in adults 18 through 50 years of age. Subjects received RAGWITEK or placebo for approximately 12 weeks prior to the start of the ragweed pollen season and throughout the ragweed pollen season.

The subject population was 86% White, 9% African American, and 3% Asian. The subject population was almost equally divided between males and females. Overall, the mean age of subjects was 36 years. Subjects with asthma who participated in clinical trials had asthma of a severity that required, at most, a daily low dose of an inhaled corticosteroid. Approximately 16% of subjects had mild asthma at baseline.

Efficacy was established by self-reporting of rhinoconjunctivitis daily symptom scores (DSS) and daily medication scores (DMS). Daily rhinoconjunctivitis symptoms included four nasal symptoms (runny nose, stuffy nose, sneezing, and itchy nose), and two ocular symptoms (gritty/itchy eyes and watery eyes). The rhinoconjunctivitis symptoms were measured on a scale of 0 (none) to 3 (severe). Subjects in clinical trials were allowed to take symptom-relieving medications (including systemic and topical antihistamines, and topical and oral corticosteroids) as needed. The daily medication score measured the use of standard open-label allergy medications. Predefined values were assigned to each class of medication. Generally, systemic and topical antihistamines were given the lowest score, topical steroids an intermediate score, and oral corticosteroids the highest score.

The sums of the DSS and DMS were combined into the Total Combined Score (TCS) which was averaged over the peak ragweed pollen season. Also, in each study, the average TCS over the entire ragweed season was assessed. Other endpoints in both studies included the average DSS during the peak and entire ragweed season, and the average DMS during the peak ragweed season.

Trial 1

The first study was a placebo-controlled trial which evaluated subjects 18 through 50 years of age comparing RAGWITEK (n=187) and placebo (n=188) administered as a sublingual tablet daily. In this trial, approximately 22% of subjects had mild asthma and 85% were sensitized to other allergens in addition to short ragweed. Subjects with asthma who participated in this trial had asthma of a severity that required, at most, a daily low dose of an inhaled corticosteroid. Subjects with a clinical history of symptomatic allergies to non-short ragweed pollen allergens that required treatment during the ragweed pollen season were excluded from the trial. The subject population was 78% White, 12% African American, and 8% Asian, and almost equally divided between males and females. The mean age of subjects in this study was 35.4 years. The two treatment groups were balanced with regard to baseline characteristics. The results of this study are shown in Table 2.

Trial 2

The second study was a placebo-controlled trial which evaluated subjects 18 through 50 years of age comparing RAGWITEK (n=194) and placebo (n=198) administered as a sublingual tablet daily. Approximately 17% of subjects had mild asthma and 78% were sensitized to other allergens in addition to short ragweed. Subjects with asthma who participated in this trial had asthma of a severity that required, at most, a daily low dose of an inhaled corticosteroid. Subjects with a clinical history of symptomatic allergies to non-short ragweed pollen allergens that required treatment during the ragweed pollen season were excluded from the trial. The subject population was 88% White, 8.9% African American, 2% Asian, and almost equally divided between males and females. The mean age of subjects in this study was 36.4 years. The two treatment groups were balanced with regard to baseline characteristics. The results of this study are shown in Table 3.

A decrease in TCS during the peak ragweed season for subjects treated with RAGWITEK compared to placebo treated subjects was demonstrated in both trials. Subjects treated with RAGWITEK also showed a decrease in the average TCS from the start of and throughout the entire ragweed pollen season. Similar decreases were observed in subjects treated with RAGWITEK for other endpoints (see Tables 2 and 3).

Table 2: Trial 1: Total Combined Scores (TCS), Rhinoconjunctivitis Daily Symptom Scores (DSS), and Daily Medication Scores (DMS) During the Ragweed Pollen Season

Endpoint* RAGWITEK (N)† Score‡ Placebo (N)† Score‡ Treatment Difference (RAGWITEK - Placebo) Difference Relative to Placebo§Estimate (95% CI)
TCS Peak Season¶ (159) 6.22 (164) 8.46 -2.24 -26% (-38.7, -14.6)
TCS Entire Season (160) 5.21 (166) 7.01 -1.80 -26% (-37.6, -13.5)
DSS Peak Season (159) 4.65 (164) 5.59 -0.94 -17% (-28.6, -4.6)
DSS Entire Season (160) 4.05 (166) 4.87 -0.82 -17% (-28.5, -4.5)
DMS Peak Season (159) 1.57 (164) 2.87 -1.30 -45% (-65.4, -27.0)
TCS=Total Combined Score (DSS + DMS); DSS=Daily Symptom Score; DMS=Daily Medication Score.
* Parametric analysis using analysis of variance model for all endpoints.
† Number of subjects in analyses.
‡ The estimated group means are reported and difference relative to placebo is based on estimated group means.
§ Difference relative to placebo computed as: (RAGWITEK - placebo)/placebo x 100.
¶Peak ragweed season was defined as maximum 15 days with the highest moving average pollen counts during the ragweed season.

Table 3: Trial 2: Total Combined Scores (TCS), Rhinoconjunctivitis Daily Symptom Scores (DSS), and Daily Medication Scores (DMS) During the Ragweed Pollen Season

Endpoint* RAGWITEK (N)† Score‡ Placebo (N)†Score‡ Treatment Difference (RAGWITEK - Placebo) Difference Relative to Placebo§ Estimate (95% CI)
TCS Peak Season¶ (152) 6.41 (169) 8.46 -2.04 -24% (-36.5, -11.3)
TCS Entire Season (158) 5.18 (174) 7.09 -1.92 -27% (-38.8, -14.1)
DSS Peak Season (152) 4.43 (169) 5.37 -0.94 -18% (-29.2, -4.5)
DSS Entire Season (158) 3.62 (174) 4.58 -0.96 -21% (-31.6, -8.8)
DMS Peak Season (152) 1.99 (169) 3.09 -1.10 -36% (-55.8, -14.6)
TCS=Total Combined Score (DSS + DMS); DSS=Daily Symptom Score; DMS=Daily Medication Score.
* Parametric analysis using analysis of variance model for all endpoints.
† Number of subjects in analyses.
‡ The estimated group means are reported and difference relative to placebo is based on estimated group means.
§ Difference relative to placebo computed as: (RAGWITEK - placebo)/placebo x 100.
¶Peak ragweed season was defined as maximum 15 days with the highest moving average pollen counts during the ragweed season.

Last reviewed on RxList: 5/2/2014
This monograph has been modified to include the generic and brand name in many instances.

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