Efficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber

In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis. We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber. In this randomized, double-blind stud...

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Vydáno v:	Journal of allergy and clinical immunology Ročník 138; číslo 2; s. 451 - 458.e5
Hlavní autoři:	Roux, Michel, Devillier, Philippe, Yang, William H., Montagut, Armelle, Abiteboul, Kathy, Viatte, Agnès, Zeldin, Robert K.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States Elsevier Inc 01.08.2016 Elsevier Limited
Témata:	Adult Allergen immunotherapy allergic rhinitis Allergies Allergy and Immunology Antigens, Dermatophagoides - administration & dosage Antigens, Dermatophagoides - immunology Area Under Curve Asthma Dermatophagoides pteronyssinus dose-ranging double-blind placebo-controlled trial Environmental Exposure environmental exposure chamber Female Forced Expiratory Volume house dust mite Humans Immunoglobulin E - immunology Immunoglobulin G - immunology Immunotherapy Investigations Male Nose Rhinitis, Allergic - diagnosis Rhinitis, Allergic - immunology Rhinitis, Allergic - therapy Sublingual Immunotherapy - adverse effects Sublingual Immunotherapy - methods sublingual immunotherapy tablet Treatment Outcome Young Adult dose-ranging EEC house dust mite AE RTSS double-blind placebo-controlled trial IR VAS environmental exposure chamber AIT ARSS AUC ChBL AVASS HDM sublingual immunotherapy tablet TEAE ARTSS allergic rhinitis Allergen immunotherapy Average Rhinitis Symptom Score Visual Analog Scale Index of reactivity Rhinitis Total Symptom Score Area under the curve Ch BL Average Rhinitis Total Symptom Score Average Visual Analog Scale Score Change from baseline Adverse event Treatment-emergent adverse event
ISSN:	0091-6749, 1097-6825
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Shrnutí:	In a natural field study, sublingual tablets of house dust mite (HDM) allergen extracts (STG320) were efficacious in treating HDM-associated allergic rhinitis. We sought to assess the efficacy and safety of 3 doses of STG320 in an environmental exposure chamber. In this randomized, double-blind study, adults with HDM-associated allergic rhinitis were given a daily sublingual tablet containing placebo or STG320 at a dose of 500IR, 300IR, or 100IR (IR, index of reactivity) for 6 months. Participants recorded their rhinitis symptoms during 4-hour HDM EEC challenges at randomization and months 1, 2, 4, and 6. The primary efficacy end point was the change from baseline to end of treatment in the area under the curve of the rhinitis total symptom score (ChBLAUCRTSS 0-4h). Differences from the placebo group were analyzed by analysis of covariance. Adverse events (AEs) and routine safety parameters were recorded. A total of 355 subjects were randomized to 1 of 4 groups: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), or placebo (n = 87). The least squares mean differences from placebo in ChBLAUCRTSS 0-4h for the 500IR, 300IR, and 100IR groups indicated a dose-dependent effect, with reductions in symptom scores of 33%, 29%, and 20%, respectively. The most frequent AEs were throat irritation and oral pruritus. There were no reports of anaphylaxis or reports consistent with severe laryngopharyngeal disorders and no use of epinephrine. AEs leading to premature discontinuations were more common in the 500IR group. A dose-dependent effect of sublingual HDM immunotherapy was demonstrated in this environmental exposure chamber study, supporting further development of this treatment.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	0091-6749 1097-6825
DOI:	10.1016/j.jaci.2016.03.039