House dust mite sublingual tablet is effective and safe in patients with allergic rhinitis

Abstract

BackgroundHouse dust mite (HDM) is the major indoor allergen for allergic diseases such as allergic rhinitis (AR) and asthma. Although sublingual immunotherapy is a curative treatment for HDM‐induced AR, data from large‐scale studies are limited. We evaluated the efficacy and safety of HDM tablets in adolescent and adult patients (aged 12–64 years) with HDM‐induced AR with or without intermittent asthma.MethodsIn a double‐blind trial in Japan, 968 subjects were randomized 1 : 1 : 1 to 300 index of reactivity (IR), 500 IR, or placebo groups. The primary endpoint was the Average Adjusted Symptom Score (AASS) in the last eight weeks of the 52‐week treatment. Secondary endpoints included individual nasal and ocular symptom scores, rescue medication use, and the Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) scores.ResultsThe AASS in the last eight weeks of treatment significantly improved in both the 300 IR and the 500 IR groups compared to that in the placebo group (P < 0.001). In the 300 IR group, the onset of action occurred at week 8–10. All four nasal symptoms significantly improved in both active treatment groups; rescue medication use and JRQLQ outcome improved in the 300 IR group. Most adverse events (AEs) were mild, and 16 serious AEs (SAEs) were reported; however, none of them were drug‐related.ConclusionsOne‐year treatment with 300 IR and 500 IR HDM tablets was effective without major safety concerns. The recommended therapeutic dose for AR is 300 IR.

Bioavailability of House Dust Mite Allergens in Sublingual Allergy Tablets Is Highly Dependent on the Formulation

“…The optimal allergen dose must always be determined in clinical trials, as each AIT product has unique properties such as allergen content (dose and composition), formulation, and treatment regimen [27]. Clinically efficacious and non-efficacious doses were identified for 2 different HDM SLIT tablets in phase 2 HDM SLIT tablet dose-finding trials [8,28,29], and the clinical efficacy of the selected treatment doses on HDM-induced AR were later confirmed for both products in large phase 3 trials [3,5,6]. The freeze-dried SQ HDM SLIT tablet also reduced the risk of moderate or severe asthma exacerbations compared to placebo in a phase 3 trial in HDM allergic asthma [7].…”

“…Unlike pharmacotherapy, AIT addresses the basic immunological mechanisms that are responsible for the development and persistence of allergic conditions. By actively modulating protective allergen-reactive pathways of the immune system, AIT can provide relief from clinical symptoms of allergic rhinitis (AR) [1,2,3,4,5,6] and allergic asthma [7,8], and it has the potential to provide long-term posttreatment symptom relief and alter the natural course of the disease [2,9,10]. Two main routes of AIT administration are commonly available, i.e., subcutaneous injections (subcutaneous immunotherapy; SCIT) and sublingual administration (sublingual immunotherapy; SLIT), the latter of which is available as a liquid formulation (SLIT drops) or in the form of tablets (SLIT tablets).…”

Efficacy of house dust mite sublingual tablet in the treatment of allergic rhinoconjunctivitis: A randomized trial in a pediatric population

“…Research has shown that the 300IR HDM tablet is effective and well tolerated in adult and adolescent patients aged 12 years and older with AR. In two double‐blind, placebo‐controlled studies in adults and adolescents with HDM‐associated AR, 300IR HDM tablets significantly reduced mean average adjusted symptom scores (AASS) compared with placebo . Although local allergic reactions occurred more frequently with active treatment than with placebo, the favorable safety profile of 300IR HDM tablets was confirmed .…”

“…In two double‐blind, placebo‐controlled studies in adults and adolescents with HDM‐associated AR, 300IR HDM tablets significantly reduced mean average adjusted symptom scores (AASS) compared with placebo . Although local allergic reactions occurred more frequently with active treatment than with placebo, the favorable safety profile of 300IR HDM tablets was confirmed . In addition, the effectiveness of one year of treatment with 300IR HDM tablets was maintained for a subsequent year after ceasing treatment .…”

“…A sublingual tablet containing standardized allergen extracts from D. pteronyssinus and D. farinae in a total allergenic activity ratio (expressed as index of reactivity [IR]) of 1:1 has been developed . Research has shown that the 300IR HDM tablet is effective and well tolerated in adult and adolescent patients aged 12 years and older with AR.…”