The SQ HDM SLIT-tablet is already approved in Europe. Is the US next?
A phase 3 trial for house dust mite (HDM) treatment proved to be safe and effective, according to the research presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI 2017) in Atlanta, Georgia.
The SQ HDM SLIT-tablet (Acarizax/ALK-Abelló) is approved across Europe to treat allergic rhinitis and allergic asthma. ALK-Abelló is based in Denmark, but its partner in the United States, Merck, submitted a license application to the US Food and Drug Administration (FDA) in early 2016.
The study was conducted in Japan and consisted of 946 participants, 278 of which were adolescents ages 12 to 17. They randomly received one of three daily treatments: HDM SLIT-tablet 6 SQ-HDM (group 1), HDM SLIT-tablet 12 SQ-HDM (group 2), and placebo (group 3).
“The primary endpoint was the total combined rhinitis score (TCRS), counting four rhinitis symptoms, and the rhinitis medication score,” the authors explained.
After one year in adolescents, TCRS was 4.0, 4.1, and 5.1 (95% confidence interval (CI), P=0.020) for groups 1, 2, and 3, respectively. When comparing group 3 to groups 1 and 2, absolute differences measured in at 1.1 (95% CI, P=0.020) and 1.0 (95% CI, P=0.037), according to the post hoc analysis.
Overall, treatment was well-tolerated. Adults and adolescents had similar efficacy and safety profiles on the HDM SLIT tablets. Average scores for rhinitis, conjunctivitis, rhinoconjunctivitis, and quality of life were all improved with the medication compared to placebo.
The researchers concluded that HDM SLIT tablets were effective in adolescents with HDM allergic rhinitis.
The study, “The SQ HDM Slit-Tablet Reduces Symptoms of House Dust Mite Allergic Rhinitis in Adolescents; A Subgroup Analysis of Results from a Dbpc Phase III Trial (TO-203-3-2),” was published in The Journal of Allergy and Clinical Immunology.