House dust mite SLIT shows promise in early trial
SAN DIEGO — A sublingual immunotherapy tablet with house dust mite being investigated for treatment of patients with allergic rhinitis with and without conjunctivitis showed potential for a clinically meaningful reduction in symptoms, according to data from a late-breaking abstract presentation here by Hendrik Nolte, MD, PhD.
“The study rationale is that the house dust mite is clearly one of the most common allergens worldwide and the prevalence of the skin prick test in the US is almost 28%,” he said.
In a study of the dose-related efficacy of MK-8237 (Merck/ALK-Abello), a randomized, double-blind, single-site trial of 124 adults with house dust mite (HDM)-induced allergic rhinitis with and without conjunctivitis (AR/C) was conducted. Patients received daily MK-8237 (12 DU, 6 DU or placebo) for 24 weeks.
Exposure challenges were conducted using a house dust mite Environmental Challenge Chamber at weeks 8, 16 and 24, with primary results based on total nasal symptom score (TNSS/sum of 4 nasal symptom scores; maximum=12) at week 24.
Researchers report that MK-8237 showed a dose-dependent effect, with a greater than 20% reduction in symptoms and the 12 DU dose showing the greatest benefit/risk ratio. Further field trials are planned to confirm the effect.
At 12 DU and 6 DU, the medication provided a 48.4% (P<.001) and 26.2% (P=.003) TNSS score improvement, respectively, at week 24 vs. placebo. TNSS scores also improved at weeks 8 (20.3%; P=.007); and week 16 (30.1%; P<.001) for the 12 DU dose, and week 24 (P=.032) for the 6 DU dose.
“The house dust mite tablet produced a significant dose-related improvement in the primary endpoint of average total nasal symptom score (TNSS) at week 24. When nasal and ocular symptoms were individually assessed through the TNSS and total ocular symptom score (TOSS), the 12 DU dose of MK-8237 demonstrated a 68% and significant improvement over placebo,” Nolte said. “MK-8237 demonstrated increasing efficacy in a dose-related manner over time-based on average TNSS and TOSS. MK-8237 was generally well-tolerated at doses of both 12 and 6 DU. The efficacy and safety results indicate that the 12 DU dose of MK-8237 is appropriate for further evaluation for the treatment of house dust mite-induced AR/C.”
For more information:
Nolte H. #L17: Dose-Finding Efficiency and Safety Trial of House Dust Mite Sublingual Immunotherapy Tablet, MK-8237, Using an Environmental Exposure Chamber. Presented at the American Academy of Allergy, Asthma & Immunology annual meeting; Feb. 28-March 4, 2014; San Diego.
Disclosures: Nolte is an employee of Merck.