Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet: Results from a randomized, double-blind, placebo-controlled phase III trial

TY - JOUR

T1 - Effective treatment of house dust mite-induced allergic rhinitis with 2 doses of the SQ HDM SLIT-tablet

T2 - Results from a randomized, double-blind, placebo-controlled phase III trial

AU - Demoly, Pascal

AU - Emminger, Waltraud

AU - Rehm, Dorte

AU - Backer, Vibeke

AU - Tommerup, Lene

AU - Kleine-Tebbe, Jörg

N1 - Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - BACKGROUND: The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)-induced respiratory allergic disease.OBJECTIVE: This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR).METHODS: The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy. Subjects were randomized 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM, or 12 SQ-HDM. The primary end point was the total combined rhinitis score (ie, the sum of rhinitis symptom and medication scores) during the efficacy assessment period (approximately the last 8 weeks of the treatment period). Key secondary end points were rhinitis symptoms, medication scores, quality of life, and the combined rhinoconjunctivitis score.RESULTS: Analysis of the primary end point (observed data) demonstrated absolute reductions in total combined rhinitis score of 1.18 (P = .002) and 1.22 (P = .001) compared with placebo for 6 SQ-HDM and 12 SQ-HDM, respectively. The statistically significant treatment effect was evident from 14 weeks of treatment onward. For all key secondary end points, efficacy was confirmed for 12 SQ-HDM, with statistically significant reductions of rhinitis symptoms and medication scores, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy assessment period compared with placebo. The treatment was well tolerated.CONCLUSION: The trial confirmed the efficacy and favorable safety profile of both 6 SQ-HDM and 12 SQ-HDM in adults with HDM-induced AR. The treatment effect was present from 14 weeks of treatment onward.

AB - BACKGROUND: The SQ HDM SLIT-tablet (ALK) has been developed for treatment of house dust mite (HDM)-induced respiratory allergic disease.OBJECTIVE: This trial investigated the efficacy and safety of the SQ HDM SLIT-tablet in adults with moderate-to-severe HDM-induced allergic rhinitis (AR).METHODS: The trial was a randomized, double-blind, placebo-controlled phase III trial conducted in 12 European countries including 992 adults with moderate-to-severe HDM-induced AR despite treatment with pharmacotherapy. Subjects were randomized 1:1:1 to 1 year of daily treatment with placebo, 6 SQ-HDM, or 12 SQ-HDM. The primary end point was the total combined rhinitis score (ie, the sum of rhinitis symptom and medication scores) during the efficacy assessment period (approximately the last 8 weeks of the treatment period). Key secondary end points were rhinitis symptoms, medication scores, quality of life, and the combined rhinoconjunctivitis score.RESULTS: Analysis of the primary end point (observed data) demonstrated absolute reductions in total combined rhinitis score of 1.18 (P = .002) and 1.22 (P = .001) compared with placebo for 6 SQ-HDM and 12 SQ-HDM, respectively. The statistically significant treatment effect was evident from 14 weeks of treatment onward. For all key secondary end points, efficacy was confirmed for 12 SQ-HDM, with statistically significant reductions of rhinitis symptoms and medication scores, improved quality of life, and a reduced combined rhinoconjunctivitis score in the efficacy assessment period compared with placebo. The treatment was well tolerated.CONCLUSION: The trial confirmed the efficacy and favorable safety profile of both 6 SQ-HDM and 12 SQ-HDM in adults with HDM-induced AR. The treatment effect was present from 14 weeks of treatment onward.

KW - Adolescent

KW - Adult

KW - Aged

KW - Allergens

KW - Animals

KW - Antigens, Dermatophagoides

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Pyroglyphidae

KW - Rhinitis, Allergic

KW - Risk Factors

KW - Sublingual Immunotherapy

KW - Time Factors

KW - Treatment Outcome

KW - Young Adult

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.jaci.2015.06.036

DO - 10.1016/j.jaci.2015.06.036

M3 - Journal article

C2 - 26292778

SN - 0091-6749

VL - 137

SP - 444-451.e8

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 2

ER -