Onset and dose-related efficacy of house dust mite sublingual immunotherapy tablets in an environmental exposure chamber

Nolte, Hendrik; Maloney, Jennifer; Nelson, Harold S.; Bernstein, David I.; Lu, Susan; Li, Ziliang; Kaur, Amandeep; Zieglmayer, Petra; Zieglmayer, René; Lemell, Patrick; Horak, Friedrich

doi:10.1016/j.jaci.2014.12.1911

Cited by 140 publications

(97 citation statements)

References 24 publications

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“…Further, at week 24, levels of both immunological parameters demonstrated a pronounced dose-dependence. Importantly, the onset and magnitude of immunological changes correlated with the observed clinical effect of the SQ HDM SLITtablet treatment on a group level [50].…”

Section: Pharmacodynamicsmentioning

confidence: 72%

“…A 24-week phase II trial assessing dose-related efficacy of the SQ HDM SLIT-tablet using an environmental exposure chamber reported comparable immunological responses [50]. Levels of specific IgE and IgG 4 increased significantly in all active groups during the initial 8 weeks of treatment, reaching levels statistically significant from those of the placebo group.…”

Section: Pharmacodynamicsmentioning

confidence: 92%

“…Clinical efficacy of the SQ HDM SLIT-tablet in HDM allergic asthma has been evaluated in three randomized, doubleblind, placebo-controlled trials [50,52,53], as outlined in Table 1. The different trial designs involving distinct asthma-specific, clinically relevant primary end points were designed to complement each other and enable independent substantiation of effect.…”

Section: Phase II and Phase Iii Studiesmentioning

confidence: 99%

“…2012-001855-38; ClinicalTrials.gov identifier NCT01644617) evaluated the treatment effect in a controlled allergen exposure environment during allergen challenge sessions throughout a treatment period of 24 weeks [50,55]. While the primary end point related to HDM allergic rhinitis, a secondary outcome of the trial was the evaluation of asthma symptoms during allergen challenge sessions, as assessed by the Average Asthma Symptom Score (AASS).…”

Section: Phase II and Phase Iii Studiesmentioning

confidence: 99%

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Efficacy and safety of SQ house dust mite (HDM) SLIT-tablet treatment of HDM allergic asthma

Canonica

Virchow

Zieglmayer

et al. 2016

Expert Review of Clinical Immunology

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Introduction: In the treatment of house dust mite (HDM) respiratory allergic disease, allergy immunotherapy constitutes an add-on treatment option targeting the underlying immunological mechanisms of allergic disease. However, for the treatment of HDM allergic asthma, the use of subcutaneous allergy immunotherapy (SCIT) has been limited by the risk of systemic adverse events. Thus, sublingually administered allergy immunotherapy (SLIT) has been investigated as a treatment option with an improved tolerability profile that allows for safer treatment of patients with HDM allergic asthma. Areas covered: In this Drug Profile, we provide a review of the clinical data behind the SQ HDM SLITtablet, which was recently approved for the treatment of HDM allergic asthma and allergic rhinitis by regulatory authorities in several European countries. Expert commentary: The SQ HDM SLIT-tablet is the first allergy immunotherapy to be tested prospectively in patients with asthma, and to favorably modify patient relevant end points such as requirement for inhaled corticosteroid (ICS) or the time to first asthma exacerbation upon ICS reduction, suggesting that SQ HDM SLIT-tablet treatment may contribute to improving overall asthma control.

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Section: Pharmacodynamicsmentioning

confidence: 72%

Section: Pharmacodynamicsmentioning

confidence: 92%

Section: Phase II and Phase Iii Studiesmentioning

confidence: 99%

Section: Phase II and Phase Iii Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and safety of SQ house dust mite (HDM) SLIT-tablet treatment of HDM allergic asthma

Canonica

Virchow

Zieglmayer

et al. 2016

Expert Review of Clinical Immunology

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“…SQ HDM SLIT-tablets have demonstrated clinical benefit in adults with HDM allergic rhinitis (with or without conjunctivitis) and HDM allergic asthma. [5][6][7][8][9][10][11] One safety trial conducted in adolescents found that SQ HDM SLIT-tablets were well tolerated. 12 Among trials that evaluated the efficacy and safety of SQ HDM SLITtablet for the treatment of moderate-severe HDM allergic rhinitis, 2 trials included adolescent subpopulations (aged 12-17 years).…”

Section: Introductionmentioning

confidence: 99%

Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents

Matsuoka

Bernstein

Masuyama

et al. 2017

Pediatric Allergy Immunology

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Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma

Virchow

Backer

Kuna

et al. 2016

JAMA

362

265

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IMPORTANCE The house dust mite (HDM) sublingual allergen immunotherapy (SLIT) tablet is a potential novel treatment option for HDM allergy-related asthma. OBJECTIVES To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid (ICS) reduction period. DESIGN, SETTINGS, AND PARTICIPANTS Double-blind, randomized, placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites. The trial included 834 adults with HDM allergy-related asthma not well controlled by ICS or combination products, and with HDM allergy-related rhinitis. Key exclusion criteria were FEV 1 less than 70% of predicted value or hospitalization due to asthma within 3 months before randomization. Efficacy was assessed during the last 6 months of the trial when ICS was reduced by 50% for 3 months and then completely withdrawn for 3 months. INTERVENTIONS 1:1:1 randomization to once-daily treatment with placebo (n = 277) or HDM SLIT tablet (dosage groups: 6 SQ-HDM [n = 275] or 12 SQ-HDM [n = 282]) in addition to ICS and the short-acting β 2-agonist salbutamol. MAIN OUTCOMES AND MEASURES Primary outcome was time to first moderate or severe asthma exacerbation during the ICS reduction period. Secondary outcomes were deterioration in asthma symptoms, change in allergen-specific immunoglobulin G4 (IgG4), change in asthma control or asthma quality-of-life questionnaires, and adverse events. RESULTS Among 834 randomized patients (mean age, 33 years [range, 17-83]; women, 48%), 693 completed the study. The 6 SQ-HDM and 12 SQ-HDM doses both significantly reduced the risk of a moderate or severe asthma exacerbation compared with placebo (hazard ratio [HR]: 0.72 [95% CI, 0.52-0.99] for the 6 SQ-HDM group, P = .045, and 0.69 [95% CI, 0.50-0.96] for the 12 SQ-HDM group, P = .03). The absolute risk differences based on the observed data (full analysis set) in the active groups vs the placebo group were 0.09 (95% CI, 0.01-0.15) for the 6 SQ-HDM group and 0.10 (95% CI, 0.02-0.16) for the 12 SQ-HDM group. There was no significant difference between the 2 active groups. Compared with placebo, there was a reduced risk of an exacerbation with deterioration in asthma symptoms (HR, 0.72 [95% CI, 0.49-1.02] for the 6 SQ-HDM group, P = .11, and 0.64 [95% CI, 0.42-0.96] for the 12 SQ-HDM group, P = .03) and a significant increase in allergen-specific IgG4. However, there was no significant difference for change in asthma control questionnaire or asthma quality-of-life questionnaire for either dose. There were no reports of severe systemic allergic reactions. The most frequent adverse events were mild to moderate oral pruritus (13% for the 6 SQ-HDM group, 20% for the 12 SQ-HDM group, and 3% for the placebo group), mouth edema, and throat irritation. CONCLUSIONS AND RELEVANCE Among adults with HDM allergy-related asthma not well controlled by ICS, the addition of HDM SLIT to maintenance medications improved time to first moderate or severe asthma exacerbation during ICS r...

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Onset and dose-related efficacy of house dust mite sublingual immunotherapy tablets in an environmental exposure chamber

Cited by 140 publications

References 24 publications

Efficacy and safety of SQ house dust mite (HDM) SLIT-tablet treatment of HDM allergic asthma

Efficacy and safety of SQ house dust mite (HDM) SLIT-tablet treatment of HDM allergic asthma

Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents

Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma

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