Sublingual Immunotherapy With Aqueous Vaccine Controls Allergic Diseases: Presented at EAACI

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Title: Sublingual Immunotherapy With Aqueous Vaccine Controls Allergic Diseases: Presented at EAACI
URL: http://www.pslgroup.com/dg/2235D6.htm
Doctor's Guide
June 11, 2008

By Chris Berrie

BARCELONA, Spain -- June 11, 2008 -- Sublingual immunotherapy (SLIT) with an aqueous allergen vaccine provides effective and uncomplicated therapy for patients with allergic rhinitis, allergic rhinoconjunctivitis, and allergic asthma, according to a prospective, postmarketing, multicentre, observational study.

The sublingual allergen vaccine provides easy and effective control of everyday allergic conditions, the researchers said in a presentation here on June 8 at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI).

Although SLIT is receiving growing acceptance as an alternative to the more traditional subcutaneous immunotherapy (SCIT), few large-scale clinical studies have been conducted to evaluate its efficacy and safety.

"This is the largest study ever done with this substance, and it was an observational study in practice conditions," said study coordinator Matthias Brautigam, PhD, Dermatology and Allergology, Clinical Research and Development, Novartis Pharma, Nuremberg, Germany.

Dr. Brautigam and colleagues conducted the observational study in Germany to investigate the efficacy and safety of SLIT with an aqueous allergen extract.

The study included 735 patients (52.5% male; mean age, 23 years) diagnosed with type 1 allergy by skin prick test. The majority of patients had allergic rhinoconjunctivitis (66.9%), followed by allergic rhinitis (41.4%), and allergic asthma (31.6%).

Patients were divided into 3 subgroups according to age, which included those younger than 12 years (27.1%), those aged 12 to 65 years (67.1%), and those aged more than 65 years (1.6%).

All patients received at least 1 allergenic extract (grass and tree pollen, house dust mite, mould, and/or animal dander). The build-up phase lasted for 12 days, followed by a maintenance phase of 12 months.

Symptom severities were assessed according to a 4-point scale from 0 to 3 (0 = no symptoms, 3 = severe), and relating to the 3 symptom domains of nose, eyes, and lungs, as compared with symptom intensity in a retrospective pretreatment period.

The mean duration of the study was 7.8 months, and 74% of the patients completed the study. Patients reporting moderate to severe symptoms prior to treatment all saw an improvement of more than 70% across the different components of the 3 symptom domains: sneezing (70.5%); nasal congestion (70.8%); runny nose (72.5%); itchy eyes (77.0%); red eyes (79.9%); swollen eyes (77.2%); shortness of breath (73.0%); wheezing (71.5%); and chest tightness (71.3%).

Efficacy was rated by the physicians as very good to good in 85.9% of cases, while the percentage of patients who rated the efficacy as very good to good was 82.6%.

Reduction in the use of concomitant allergy medications was achieved in 21.1% of patients. About 95% of the physicians and patients assessed the practicability of the treatment as good or very good.

The percentage of physicians and patients who rated the tolerability of the vaccine as very good or good was 93.6% and 91.2%, respectively.

Adverse reactions included oral swelling (14.6%) and oral burning (21.2%), most of which (89%) were mild. Two patients discontinued therapy due to local reactions.

Funding for this study was provided by Novartis Pharma GmbH.

[Presentation title: Efficacy and Safety of Specific Sublingual Immunotherapy for the Treatment of Allergic Rhinitis, Allergic Rhinoconjunctivitis and Allergic Asthma. Late Breaking Poster Session – Clinical Posters – Immunotherapy/Treatment of Allergic Diseases. Abstract P1750]

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