Mite allergy: the new treatment for sublingual desensitization - After its approval last year in several European countries, Acarizax®, the KLA laboratory, was approved in France earlier this year as hyposensitization treatment sublingually in patients with allergic rhinitis or allergic asthma to House mites duly confirmed by tests allergy and insufficiently controlled by their treatment.
Mite allergy: the new treatment for sublingual desensitization
One of the most common allergies
House mites are responsible for a large number of, including respiratory allergies (allergic rhinitis, asthma). House dust mites are the cause of the most common allergyin the world, and the France is not the exception. Allergy to dust mites affect about90 million people in Europe, to the Japan and North America, and more than 100 million in China. It is estimated that allergic rhinitis to one in 10 adults is poorly controlled with current standard therapies.
Ongoing studies for several years
Acarizax® has been the subject of several multicenter studies including hundreds ofpatients in many countries. The two studies pivotal phase III earned him approval inEurope are:
For allergic rhinitis, the MERIT (MT-06) study which included 992 adults with allergicrhinitis to moderate to severe House mites, insufficiently controlled despite appropriate symptomatic treatment. The patients were divided into 3 groups to receive, during a year, or Acarizax® at the dose of 12 SQ - HDM (units standardized house dustmites purified in sublingual tablets), or Acarizax® at a dose of 6 SQ - HDM, a placebo (a substance without therapeutic effect). The main objective was to assess the severity of the symptoms and the use of drugs during the last 8 weeks of treatment using a scale validated evaluating 4 symptoms and the amount of nasal corticosteroidsand antihistamines consumed. A significant decrease in scores (at the level of symptoms and medication use) was observed in the Group of patients treated with Acarizax® at a dose of 12 SQ - HDM, compared to the 2 other groups. Moreover, the quality of life measured by a specific allergic rhinitis scale was also evaluated. It was alsosignificantly improved in patients having taken Acarizax® at a dose of 12 SQ - HDM, compared to other patients.
For asthma, the MITRA (MT - 04) study which included 834 adult asthma patients allergic to mites poorly controlled (CI) inhaled corticosteroids. The methodology was similar to that of the study on allergic rhinitis: the patients daily, either with one doseof 12 SQ - HDM, either with one dose of 6 SQ - HDM, either with a placebo in addition to the CI and short duration of action (SABA) beta2-agonists bronchodilators. After a period of treatment ranging between 7 and 12 months, the daily amount of CIwas reduced by half for 3 months, then stopped completely for another 3 months for patients who did not have their asthma exacerbation. The primary endpoint of the trial was the reduction of the risk of exacerbations of asthma of moderate to severein the period of reduction of corticosteroids, measured from the time elapsed until the occurrence of the first exacerbation. The test showed that the dose of 12 SQ - HDM (approved dose in the EU) has considerably reduced risk of exacerbation of asthma of moderate to severe by 34% compared to placebo (including the risk of exacerbation associated with an increase in Nighttime Awakenings or daytime symptoms, exacerbations associated with an increase in the consumption of SABA and exacerbations with deterioration of respiratory function).
In these studies, the most common side effects were itching for light to moderate atthe level of the mouth, swelling of the mouth and throat irritation.
The indications in the European Union
Following the results of these studies, in Europe, Acarizax® is indicated in adult patients (18 to 65 years) who, on the basis of a diagnosis involving an evocative clinicalhistory and positivity of a specific test of awareness of the (prick skin test and/or presence of IgE) house dust mites, are:
- a persistent allergic rhinitis moderate to severe mite insufficiently controlled by symptomatic treatment
- mites allergic asthma inadequately controlled with corticosteroids inhaled and associated with a slight allergic rhinitis to severe mite. Asthma patient must be carefully assessed before the initiation of therapy.
For the first author of the study on asthma, Professor J Christian Virchow Universityof Rostock (Germany), "JAMA (Journal of the American Medical Association) is partof the most prestigious and influential medical journals in the world, and its decision to publish these decisive results of the clinical development of Acarizax® programdemonstrates the revolutionary nature of this new treatment".
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