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 - 05/02/16
, Waltraud Emminger, MD b, Dorte Rehm, PhD c, Vibeke Backer, MD d, Lene Tommerup, MSc c, Jörg Kleine-Tebbe, MD eAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Allergy immunotherapy, sublingual immunotherapy tablet, sublingual immunotherapy, allergen immunotherapy, allergy, allergic rhinitis, house dust mite, Rhinitis Quality of Life Questionnaire, rhinoconjunctivitis, total combined rhinitis score
Abbreviations used : AE, AR, AIT, FAS, FAS-MI, HDM, ICH, ICS, IMP, LME, PP, RQLQ, SLIT, TCRS
Plan
| Supported by ALK, Hørsholm, Denmark. |
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| Disclosure of potential conflict of interest: P. Demoly has received consultancy fees from ALK, Circassia, Stallergenes, Allergopharma, Thermo Fisher Scientific, and DBV; has received consultancy fees from Chiesi and Pierre Fabre Medicaments; and has received lecture fees from Ménarini, MSD, AstraZeneca, and GlaxoSmithKline. W, Emminger has received consultancy fees and travel support from ALK. D. Rehm has stock/stock options in ALK. L. Tommerup was employed by ALK as a Clinical Project Manager for the trial. J. Kleine-Tebbe has received consultancy fees, travel support, participation fees, and speaker's fees from ALK; is a board member for Leti; has received consultancy fees from Merck, Circassia, Leti, and Novartis; and has received lecture fees from ALK, Allergopharma, Bencard, HAL Allergy, Lofarma, Novartis, and Stallergenes. V. Backer declares no relevant conflicts of interest. |
Vol 137 - N° 2
P. 444 - février 2016 Retour au numéro
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