Pharmacodynamic and pharmacokinetic evaluation of house dust mite sublingually administered immunotherapy tablet in the treatment of asthma.

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Mauro M, Boni E, Makri E, Incorvaia C

Pharmacodynamic and pharmacokinetic evaluation of house dust mite sublingually administered immunotherapy tablet in the treatment of asthma.

Expert Opin Drug Metab Toxicol. 2015;11(12):1937-43. doi: 10.1517/17425255.2015.1113255. Epub 2015 Nov 13.

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26565665 [ View in PubMed
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Abstract

INTRODUCTION: Sublingual immunotherapy (SLIT) for house dust mite (HDM) allergy has an evidence of efficacy demonstrated by meta-analyses, but marked differences are reported between the various SLIT products. The standardized quality (SQ) HDM sublingual tablet containing Dermatophagoides pteronyssinus and Dermatophagoides farinae in a 1:1 ratio (MK-8237) is a qualitative advance for SLIT products. AREAS COVERED: The rationale for developing the HDM tablets is discussed against the other available SLIT products, analyzing the clinical data on efficacy and safety obtained by controlled trials. EXPERT OPINION: Following preliminary Phase I and II studies, a double-blind, placebo-controlled trial on 604 patients with mite-induced asthma, aged more than 14 years and treated by inhaled budesonide, was performed using one of three active doses (1, 3 or 6 SQ) or placebo. The results showed a significant mean difference between 6 SQ-HDM and placebo in the reduction in daily budesonide dose of 81 microg (p = 0.004), with relative mean and median reductions of 42 and 50% for 6 SQ-HDM and 15 and 25% for placebo, respectively. Safety was very good, with no report of anaphylactic reaction. These findings suggest a role to the HDM SLIT tablets in the treatment of patients with mite-induced asthma.

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