Phase 3 Study Examines Long-Term Grass Pollen Allergy Treatment
MARCH 03, 2017
A collaborative team of researchers evaluated the 300IR 5-grass pollen sublingual tablet in people who experienced adverse reactions. Their findings were presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI 2017) in Atlanta, Georgia.
The double-blind phase 3 trial included patients with confirmed grass pollen-induced allergic rhinoconjunctivitis (ARC) for at least two years.
The participants were ages 18 to 50 and randomly assigned to one of two groups: 300IR tablet or placebo, pre-seasonally (four months or two months before) and co-seasonally for three consecutive years. Follow-up continued for two years after treatment. Adverse reactions were reported in patients who were treated for at least two seasons.
For the first year, a total of 633 adults had at least one treatment dose—300IR for four months (207 patients), 300IR for two months (207 patients), and placebo (219 patients). Many patients experienced at least one adverse reaction in all three groups: 71%, 57%, and 25%, respectively.
In participants who moved on to a second year of treatment, at least 62% in the 300IR four months and two months groups and 27% in the placebo group experienced adverse reaction. By year three, these numbers decreased to at least 51% in the 300IR four months and two months groups and 8% in the placebo group.
The most frequent adverse reactions were typically mild and occurred within the first week of treatment. The most common adverse reactions, which were the same every year, were application-site reactions, such as oral pruritus, throat irritation, mouth edema, and ear pruritus. These generally last one to four months.
Although many patients experienced adverse reactions, they decreased over time and were usually mild and cleared within a few months.
The study, “Long-Term Treatment with 300IR 5-Grass Pollen Sublingual Tablet in Grass Pollen Allergic Subjects: Safety Outcomes Year after Year,” was published in The Journal of Allergy and Clinical Immunology.
>>> More AAAAI 2017 Coverage Here