ATLANTA, GA—Safety data of long-term treatment with 300IR 5-grass sublingual tablet indicated that “the most frequent adverse reactions (ADRs) were generally mild and mostly occurred within the first 1–2 weeks of treatment initiation every year,” reported David Golden, MD, of the Medstar Franklin Square Medical Center, in Baltimore, MD, at the 2017 AAAAI Annual Meeting.
This Phase 3, double-blind, placebo-controlled, multicenter study analyzed ADR incidence in patients aged 18–50 years with medically confirmed grass pollen-induced allergic rhinoconjunctivitis (ARC) for ≥2 years receiving this long-term immunotherapy. The 5-grass pollen sublingual tablet was a Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue grass mixed pollens allergen extract. Patients were randomized to receive either placebo or a 300IR sublingual tablet taken 2 months (2M) or 4 months (4M) pre-seasonally and then co-seasonally for 3 consecutive years. Patients were assessed for 2 years post-treatment.
In Year 1 of the study, a total of 633 patients received at least one dose of the 300IR sublingual tablet. The data found that ≥1 ADR was reported in 71% of patients receiving 300IR 4M, 57% of patients receiving 300IR 2M vs. 25% of patients receiving placebo. In Year 2, 69% of patients receiving 300IR 4M, 62% of patients receiving 300IR 2M presented with ADRs vs. 27% of patients receiving placebo. In Year 3 of the study, 55% of patients receiving 300IR 4M, 51% of patients receiving 300IR 2M presented with ADRs vs. 8% of patients receiving placebo. The study authors noted that application site reactions were the most frequently reported ADRs each year.
Safety data obtained from this Phase 3 study indicated that ADRs associated with long-term treatment with 300IR 5-grass sublingual tablet were generally mild, could continue for up to 4 months of treatment, and occurred with decreased frequency over the years. Dr. Golden noted that the safety profile “was similar in both active treatment groups 300IR 4M and 2M especially during Year 2 and Year 3.”