Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2  years after treatment cessation, as measured by a recommended XXXX .

@entity1 @entity7370 @entity56 @entity2794
BACKGROUND: The 300IR (index of reactivity) 5-grass pollen tablet has favorable short-term and sustained clinical efficacy in @entity1 with grass pollen-induced @entity56 ( @entity56 ). Here, we report maintenance of efficacy and safety over 2  years following treatment discontinuation. METHODS: Randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 trial in @entity1 aged 18-50 years with @entity56 . During study years 1-3, @entity1 received a daily sublingual tablet containing either 300IR 5-grass pollen extract or placebo, according to a discontinuous pre- and coseasonal protocol. Study years 4 and 5 were treatment-free. In response to health authorities' recommendations, the @entity2794 ( @entity2794 ) was assessed in a post-hoc analysis as the efficacy endpoint. Components of the @entity2794 were daily @entity7370 total symptom score (DRTSS) and daily rescue medication score (DRMS). RESULTS: 633 @entity1 with @entity56 were randomized to placebo (n   =   219) or 300IR 5-grass pollen tablet, beginning 4  months (4  M, n   =   207) or 2  months (2  M, n   =   207) prior to the estimated start of the grass pollen season and continuing until season's end. During the first post-treatment year, a statistically significant difference versus placebo in least squares (LS) mean @entity2794 was noted in @entity1 previously receiving active treatment (300IR (2  M) point estimate: -0.16, 95% confidence interval (CI95%): [-0.26, -0.06], p   =   0.0019; -31.1%; 300IR (4  M) point estimate: -0.13, CI95%: [-0.23, -0.03], p   =   0.0103, -25.3%). During the second post-treatment year, @entity1 in the 300IR (4  M) group, but not the 300IR (2  M) group, showed a statistically significant difference in LS mean @entity2794 versus placebo (point estimate: -0.11, CI95%: [-0.21; 0.00], p   =   0.0478, -28.1%). This significant efficacy seen during the post-treatment years in @entity1 previously treated with 5-grass pollen tablet compared favorably with that during the 3 prior years of active treatment. A statistically significant difference versus placebo was also noted in secondary efficacy measures in both post-treatment years (except for DRTSS in year 5). In the absence of any active treatment, the safety profile was similar in the active groups versus placebo group during either post-treatment year. CONCLUSIONS: In adults with grass pollen-associated @entity56 , 5-grass pollen tablet therapy beginning 4  months before the pollen season and continuing to season's end demonstrated efficacy across all variables during active treatment, and this effect was prolonged for up to 2  years post-treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00418379.
