Sublingual Immunotherapy Benefits for Grass-Induced Asthma: Presented at EAACI
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Sublingual Immunotherapy Benefits for Grass-Induced Asthma: Presented at EAACI

By Chris Berrie

BARCELONA, Spain -- June 12, 2008 -- Sublingual immunotherapy (SLIT) is not inferior to inhaled budesonide for relief of bronchial symptoms in patients with grass-induced asthma and rhinitis, while it provides additional significant benefit over budesonide for nasal symptoms, eosinophils, and methacholine reactivity.

Principal investigator Giovanni Passalacqua, MD, Department of Internal Medicine, University of Genoa, Genoa, Italy, presented results of a randomised, open, parallel-group study here on June 9 at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI).

"The rationale behind this study is that indeed we have very few studies directly comparing immunotherapy in general and drugs, and these few studies were performed over the very short term," Dr. Passalacqua said. As immunotherapy takes time to fully develop effects, these studies have favoured the drugs.

The aim was thus to directly compare SLIT and inhaled budesonide over the long term.

After screening 92 patients with mild persistent asthma and rhinitis who were solely allergic to grass pollen, the 51 patients with poor response to low-dose budesonide 400 mcg/day (n = 51) were followed for a single season and were then randomised to either SLIT (n = 25; age range, 18-43 years; male, 60.0%) or budesonide (n = 26; age range, 18-41 years; male, 65.4%).

The SLIT treatment was applied as oral drops, with 20-day up-dosing, and then maintenance treatment on alternate days for 4 years. Budesonide 800 mcg/day was applied daily as an inhaled or nasal spray throughout the pollen season. Both treatments were accompanied by oral antihistamine (cetirizine 10 mg), with rescue treatment also allowed, during the pollen season.

Baseline clinical characteristics of the treatment groups were similar for lower airway symptom (LAS) score (156 vs 175, respectively), upper airway symptom (UAS) score (103 vs 116), nasal eosinophils (14% vs 12%), and methacholine reactivity (325 vs 300 mcg).

The researchers evaluated patients using a clinical diary throughout the season measuring 4 nasal symptoms (UAS: itch, sneeze, rhinorrhoea, obstruction) and 4 bronchial symptoms (LAS: cough, wheeze, shortness of breath, chest tightness). They used 4-point scales (0 = no symptoms, 4 =severe), with the addition of 1 point for each dose of either nasal beclomethasone dipropionate (upper airway) or salbutamol (lower airway). Nasal eosinophils (in season) and methacholine reactivity (out season) were also monitored.

After 2 years, LAS scores were not different between treatment groups, while UAS scores showed significant nasal symptom benefits for SLIT (P < .01). After 4 years of treatment, SLIT showed significant favourable benefits over budesonide for both LAS (P < .01) and UAS (P < .001).

Patients in the SLIT group had significant reductions in levels of in-season eosinophils and out-season methacholine reactivity, after both 2 (P < .01; P < .001; respectively) and 4 (P < .001; P < .01) years.

Dr. Passalacqua concluded, "Under these conditions, sublingual immunotherapy is even more effective than inhaled steroids in controlling asthma symptoms, and anyway, sublingual immunotherapy adds value to the treatment since it can act on both lower and upper respiratory airways."

[Presentation title: Long-Term Comparison of the Efficacy of Sublingual Immunotherapy vs Inhaled Budesonide in Grass-Induced Asthma. Abstract O96]

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