If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Sustained Disease Modifying Effects of SQ-Standardised Grass Allergy Immunotherapy Tablet at 2 Years: Presented at EAACI By Sara Freeman LONDON -- June 10, 2010 -- Two years after completing treatment with a subcutaneous (SQ)-standardised grass allergy immunotherapy tablet (AIT), significant disease-modifying activity can still be observed, according to follow-up data from a phase 3 study presented here at the 29th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). Analysis of 241 patients included in the randomised, double-blind, placebo-controlled trial demonstrated a 31% reduction in the median rhinoconjunctivitis symptom score when comparing the actively treated (n = 137) patients with those given placebo. Stephen R. Durham, MD, National Heart Lung Institute, Imperial College London, United Kingdom, presented the study findings on June 7. The GT-08 study was conducted in 43 sites in 7 European countries and ran for 3 years (2005-2007). During the trial, adult patients with a clinical history of moderate to severe grass pollen allergy inadequately controlled by the use of symptomatic medications were treated with either the AIT (Grazax, 75,000 SQ-T/2/2,800 BAU) or placebo during the main pollen seasons. At the end of the main trial, patients continued to be followed for a further 2 pollen seasons (2008-2009). Dr. Durham reported the findings of the last year of the GT-08 extension period, covering the entire 2009 pollen season. These showed that the adjusted mean Rhinoconjunctivitis Symptom Scores were significantly lower in the AIT arm than in the placebo arm (2.56 vs 3.40; 24.8% difference; P = .004). Comparing the year 5 findings with the previous pollen seasons' results, a consistent effect was seen with reductions in median total daily rhinoconjunctivitis scores of 32% in the first year, 44% in the second year, 37% in the third year, and 31% in the fourth year. "The Grazax group had nominally less use of symptomatic medication 2-years post treatment," Dr. Durham said. The adjusted mean Rhinoconjunctivitis Medication Scores were 3.04 for placebo and 2.42 for the AIT (20% difference; P = .11). The median difference between the groups was 21%. Differences in the Combined Symptom and Medication Score were also in favour of the active therapy over placebo. Treatment-related adverse events decreased over time, with the level of local adverse events approaching placebo, Dr. Durham observed. Most treatment-related reactions were mild to moderate, and no serious treatment-related side effects were reported during the entire trial. "This trial is the first large-scale, randomised, placebo-controlled trial showing long-term disease modification after treatment with Grazax," Dr. Durham concluded. [Presentation title: Disease-Modifying Effect of the SQ-Standardised Grass Allergy Immunotherapy Tablet Is Sustained 2 years After Treatment. Abstract 1875]
|
