Post-hoc analysis of MERIT Phase III trial of Odactra shows better sleep for allergic rhinitis patients

ALK has released new analysis of clinical trial data showing that its Odactra (sublingual allergy immunotherapy tablet or SLIT) for the treatment of house dust mite (HDM)-related allergy can significantly improve quality of sleep for allergic rhinitis patients. Data were gathered during a post-hoc analysis of data from the MERIT Phase III clinical trial to evaluate the efficacy and safety of the HDM SLIT-tablet in the treatment of allergic rhinitis.

ALK’s HDM SLIT-tablet has previously been shown to be effective in treating HDM-induced allergic rhinitis and/or conjunctivitis as well as HDM-induced allergic asthma. This new analysis of the MERIT trial data was conducted using data from a Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), which participants completed at the outset of the MERIT trial and throughout the treatment period. Sleep issues were tracked via scores ranging from 0 (not troubled) to 6 (extremely troubled), rating three common consequences of HDM allergy symptoms: lack of a good night’s sleep, waking during the night, and difficulty getting to sleep. Analysis showed that, at the beginning of the trial, approximately 65% of participants had moderately or severely affected sleep. Of those, the majority saw an improvement following treatment with the HDM SLIT-tablet with only 7.3-10.1% remaining in the moderate/severe category at the end of trial.

This improvement was significantly better than that observed following treatment with placebo. In addition, the RQLQ adjusted mean score for the sleep scores was significantly better among the HDM SLIT-tablet group than for the placebo group. The results were presented as a scientific poster at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology.