title: Pharmacodynamic and pharmacokinetic evaluation of house dust mite sublingually administered immunotherapy tablet in the treatment of asthma.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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 µg (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.
authors.affiliation: a Allergy Unit , Sant'Anna Hospital , Como , Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Mauro
authors.affiliation: a Allergy Unit , Sant'Anna Hospital , Como , Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Boni
authors.affiliation: b Allergy/Pulmonary Rehabilitation , ICP Hospital , Milan 20100 , Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Makri
authors.affiliation: b Allergy/Pulmonary Rehabilitation , ICP Hospital , Milan 20100 , Italy.
authors.forename: Cristoforo
authors.initials: C
authors.lastname: Incorvaia
mesh_terms: D000818:Animals; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D019819:Budesonide / Q000008:administration & dosage; D006801:Humans; D039981:Pyroglyphidae / Q000276:immunology*; D063729:Sublingual Immunotherapy / Q000009:adverse effects / Q000379:methods*; D013607:Tablets
chemical_list: D001993:Bronchodilator Agents; D013607:Tablets; D019819:Budesonide
keywords: asthma; house dust mite; sublingual immunotherapy; tablets