Stallergenes is a European biopharmaceutical company working on the prevention and treatment of allergy-related respiratory diseases.
They have been conducting a phase IIb/III clinical trial, with a sublingual tablet in adults suffering from moderate to severe persistent allergic rhinitis to house dust mites, including 509 patients, over seven countries, with a full year of treatment from January to December 2008. This study compared two treated groups, one with a daily intake of 300 IR sublingual tablet, the other of 500 IR, with a placebo group.
The two groups demonstrated a highly significant statistical difference fromthe placebo group but with no difference between the two treated groups. In the different groups, use of rescue medication was allowed throughout the period. Symptoms overall in the two treated groups were improved by 20%, nasal congestionimproving by 40% and nasal pruritus by 32%.
Moreover, improvements were noticeable from the 4th month of treatment, meaning that the difference between the placebo and the treated groups was statistically significant, the treatment effect being maintained at the same level up to the end of the study.
The quality of life has been statistically improved and the proportion of symptom-controlled days increased by 52%.
05/09 and 1/10
Clinical efficacy and immunological mechanisms of sublingual and subcutaneous immunotherapy inasthmatic/rhinitis children sensitised to house dust mite: an open randomized controlled trial
A. O. Eifan , T. Akkoc , A. Yildiz , S. Keles , C. Ozdemir , N. N. Bahceciler and I. B. Barlan. Division of Pediatric Allergy and Immunology, Marmara University Medical Faculty, Istanbul, Turkey and Allergy & Clinical Immunology Section, NHLI, Imperial College, Faculty of Medicine, London
Clinical & Experimental Allergy on line - January 10
In children, the clinical efficacy and immunological mechanisms of sublingual immunotherapy (SLIT) compared with subcutaneous immunotherapy (SCIT) is still to be elucidated.
To compare SLIT, SCIT and pharmacotherapy in relation to clinical efficacy and immunological mechanisms that govern its effect in asthmatic/rhinitis children who were sensitized to house dust mite (HDM).
In this single centre, prospective, randomized, controlled, open labelled, three parallel group trial, 48 patients mono-sensitized to HDM were randomized to receive either SLIT (n=16), SCIT (n=16) or pharmacotherapy alone (n=16). Symptom, medication and visual analogue score (VAS) were collected and bronchial-nasal hyper-reactivity, skin prick tests, total-specific IgE were performed at baseline and 12 months after treatment. In addition, peripheral blood mononuclear cells were cultured with recombinant Der p 1 and Bet v 1 extracts and allergen-specific IL-4, IL-5, IL-13, IFN-γ, IL-10, and TGF-β secretions were measured.
SLIT and SCIT demonstrated a significant reduction of total rhinitis and asthma symptom score, total medication score, VAS and skin reactivity to HDM (P<0.05) when compared with pharmacotherapy. A significant reduction of serum-specific HDM-IgE in SCIT and SLIT were observed. Moreover, titrated nasal provocative dose significantly increased in both immunotherapy groups when compared with the pharmacotherapy group. No adverse effects were reported in SLIT, while two patients demonstrated serious adverse events in SCIT. After 1 year of treatment, Der p 1-driven IL-10 significantly increased in SLIT compared with pharmacotherapy, whereas Bet v 1-driven TGF-β (negative control) increased significantly in SLIT only. No changes were observed for Th1–Th2 cytokines.
Both SLIT and SCIT demonstrated clinical improvement compared with pharmacotherapy in asthma/rhinitis children sensitized to HDM.
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First Published in May 2009
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