Large randomized trial in Japan shows improvement in Average Adjusted Symptom Score
WEDNESDAY, Aug. 3, 2016 (HealthDay News) — For patients with allergic rhinitis (AR), house dust mite (HDM) sublingual immunotherapy is effective and seems safe, according to a study published online July 29 in Allergy.
Yoshitaka Okamoto, M.D., Ph.D., from Chiba University in Japan, and colleagues examined the safety and efficacy of HDM tablets in adolescents and adults (aged 12 to 64 years) with HDM-induced AR with or without intermittent asthma. A total of 968 subjects were randomized to 300 index of reactivity (IR), 500 IR, or placebo groups in a double-blind trial. The Average Adjusted Symptom Score (AASS) in the last eight weeks of the 52-week treatment was assessed as the primary outcome.
The researchers found that, compared to the placebo group, there was significant improvement in the AASS in the last eight weeks of treatment with 300 IR and 500 IR (P < 0.001). The onset of action occurred at week eight to 10 in the 300 IR group. In both active groups there was significant improvement in all four nasal symptoms; there was improvements in rescue medication use and Japanese Rhinoconjunctivitis Quality of Life Questionnaire outcome scores in the 300 IR group. There were no drug-related adverse events reported.
“One-year treatment with 300 IR and 500 IR HDM tablets was effective without major safety concerns,” the authors write. “The recommended therapeutic dose for AR is 300 IR.”
Several authors disclosed financial ties to Shionogi, which funded the study.
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