SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms

February 2015 Volume 114, Issue 2, Pages 134–140.e1

Holger Mosbech, MD

, 

G. Walter Canonica, MD

, 

Vibeke Backer, MD

, 

Frederic de Blay, MD

, 

Ludger Klimek, MD

,

Louise Broge, PhD

, 

Christian Ljørring, MSc

Open Access

DOI: http://dx.doi.org/10.1016/j.anai.2014.11.015

Open access funded by the Author(s)

Article Info

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Abstract

Background

House dust mite (HDM) allergy is associated with persistent allergic rhinitis (AR) and allergic asthma.

Objective

To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease and report the AR results.

Methods

Six hundred four subjects at least 14 years old with HDM AR and mild to moderate HDM allergic asthma were randomized 1:1:1:1 to double-blinded daily treatment with 1, 3, 6 SQ-HDM or placebo. End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points. A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score (TCRS) > 0 (ie, with AR symptoms and/or AR medication use during the 4-week baseline period). The subgroup was comprised of 498 subjects (82%).

Results

In the subgroup, the absolute difference in end-of-treatment TCRS between 6 SQ-HDM and placebo was −0.78 (95% confidence interval −1.47 to −0.07, relative difference 28.8%, P = .0357). Furthermore, a significant difference was found for the total score of the Rhinitis Quality of Life Questionnaire with Standardized Activities RQLQ(S) and for the individual domains: activities, sleep, non-nose and non-eye symptoms, and nasal symptoms. For the TCRS and Rhinitis Quality of Life Questionnaire score, a dose response was seen, with numerically lower, nonsignificant differences for 1 and 3 SQ-HDM. The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups. No safety concerns were observed.

Conclusion

Efficacy in mild to severe AR of 6 SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Questionnaire score in subjects with AR present at baseline. The treatment was well tolerated.

Trial Registration

EudraCT, no 2006-001795-20; ClinicalTrials.gov, identifier NCT00389363.

Disclosure: Dr Mosbech previously received funding from ALK. Dr Klimek received grants, honoraria, and consulting fees from ALK (Hoersholm Denmark). Mr Ljørring owns ALK stock. L.B. and C.L. are employees of ALK. The remaining authors declared no conflicts of interest.

Funding: The trial was sponsored by ALK (Hørsholm, Denmark) who assumes overall responsibility for the trial and was involved in the trial design and conduct.

© 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc.mend

February 2015 Volume 114, Issue 2, Pages 134–140.e1