Abstract | BACKGROUND: METHODS: This was an analysis of pooled data for a prespecified subgroup of Canadian subjects from two multicentre, randomized, double-blind placebo-controlled trials of ragweed sublingual tablet (SLIT-T; 6 and 12 Amb a 1-U of Ambrosia artemisiifolia) in patients aged ≥18y, with ragweed-induced allergic rhinoconjunctivitis (AR/C) with or without asthma. Randomized subjects used once-daily ragweed SLIT-T or placebo for at least 12 weeks before the ragweed season and for up to 52 weeks post-randomization. The primary efficacy endpoint was the total combined score (TCS) based on the sum of AR/C daily symptom score (DSS) and daily medication score (DMS) averaged over the peak season. Treatment effects on TCS, DSS, and DMS in the entire season were also assessed. Adverse events (AEs) were monitored to assess safety. RESULTS: 337 Canadian subjects were randomized in the two trials. During the peak season, ragweed SLIT-T 6 and 12 Amb a 1-U significantly reduced TCS by 26% (difference, -2.46 score point; p = .0009) and 40% (difference, -3.75 score point; p < .0001), respectively. In the overall population (N = 961), TCS reductions with 6 and 12 Amb a 1-U were 20% and 23%, respectively (both p < .001). Clinically meaningful reductions in entire-season TCS in Canadians were similar to those during peak ragweed season. Dose-dependent reduction of DSS and DMS was also observed for ragweed SLIT-T 6 and 12 Amb a 1-U during the peak season and the entire season. Ragweed SLIT-T was well tolerated in Canadian subjects and the overall population. Adverse events were generally mild to moderate and transient, occurring early in treatment; no systemic allergic reaction/ anaphylaxis was noted. CONCLUSION: Ragweed SLIT-T is an effective form of immunotherapy that provides symptomatic efficacy of AR/C with a favorable risk profile in Canadian and overall populations. TRIAL REGISTRATION: Clinicaltrials.gov identifiers NCT00783198 and NCT00770315.
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Authors | Harold Kim, Susan Waserman, Jacques Hébert, Michael Blaiss, Harold Nelson, Peter Creticos, Amarjot Kaur, Jennifer Maloney, Ziliang Li, Hendrik Nolte |
Journal | Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology
(Allergy Asthma Clin Immunol)
Vol. 10
Issue 1
Pg. 55
( 2014)
ISSN: 1710-1484 [Print] England |
PMID | 25788949
(Publication Type: Journal Article)
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