Significant efficacy demonstrated throughout peak ragweed pollen season (RPS)
- Peak ragweed pollen season was when patients had the most symptoms
RAGWITEK provided 26% and 24% TCS decreases vs placebo in Trial 1 and Trial 2, respectively
- Trial 1: Average TCS of 8.46 and 6.22 for placebo (n=164) and RAGWITEK (n=159), respectively (95% CI: -38.7%, -14.6%).
- Trial 2: Average TCS of 8.46 and 6.41 for placebo (n=169) and RAGWITEK (n=152), respectively (95% CI: -36.5%, -11.3%).
TRIAL 1 and TRIAL 2 STUDY DESIGN: The efficacy of RAGWITEK was investigated in 2 double-blind, placebo-controlled, allergy immunotherapy studies. Patients (18 through 50 years of age) with at least a 2-year history of physician-diagnosed ragweed pollen-induced allergic rhinitis with or without conjunctivitis, who had received treatment the previous RPS, and who had sensitivity to short ragweed as determined by positive skin prick and IgE tests were randomized to receive RAGWITEK (Trial 1: n=187; Trial 2: n=194) or placebo (Trial 1: n=188; Trial 2: n=198) daily for at least 12 weeks prior to RPS, throughout RPS, and after RPS for a total of ~52 weeks of treatment. Patients in both arms of the study were additionally permitted to take symptom-relieving allergy medications as needed. Reasons for exclusion included clinical history of allergic rhinitis due to non-short ragweed pollen allergens that required treatment overlapping RPS, and severe asthma or asthma that required medium-/high-dose ICS. 85% and 76% to 79% of patients in Trial 1 and Trial 2, respectively, were sensitized to other allergens in addition to short ragweed pollen, including grass, tree, pet dander, dust mites, and mold. Overall, patients in these studies had a mean age of 36 years, were almost equally divided between males and females, and were 86% white, 3% Asian, and 9% African American. Patients with asthma who participated in these studies had asthma of a severity that required, at most, a daily low dose of an ICS; approximately 16% had mild asthma at baseline, and FEV1 needed to be ≥ 70% predicted. The primary endpoint was TCS, which is the averaged sum of DSS and DMS, during peak RPS. Key secondary endpoints included average TCS over the entire RPS, average DSS during peak and entire RPS, and average DMS during peak RPS. 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 2 points/spray, and oral steroid as 1.6 points/tablet on Day 1 and, for Trial 1 only, as 1.6 x 2 points/tablet from Day 2 onward, for a maximum daily total of 36. Relative differences (% decreases) were calculated as follows: (RAGWITEK-placebo)/placebo x 100.
ICS=inhaled corticosteroid; FEV1=forced expiratory volume in 1 second.