Examining the Time to Therapeutic Effect of @entity4481 in @entity1566 @entity1 With XXXX .

@entity1 @entity158 @entity1566 @entity4481 @entity9
PURPOSE: In 2 large-scale, placebo-controlled trials, @entity4481 improved both @entity158 and @entity158 interference in @entity1 with @entity9 due to @entity1566 ( @entity1566 ). In both trials, @entity4481 found statistically significant improvement compared with placebo after 1 week of treatment. However, the effects of @entity4481 in the days immediately after initiation of treatment are unknown. The purpose of the present analysis was to determine timing of @entity4481 's therapeutic effect in the days after initiation of treatment. METHODS: Data were derived from 2 trials of @entity4481 in @entity1 with @entity1566 -related @entity9 . Each day @entity1 rated severity of @entity158 and @entity158 interference over the past 24 hours on a scale from 0 to 10, with higher scores indicating greater severity. To quantify timing of therapeutic effect, we compared ( @entity4481 [vs] placebo) daily average @entity158 and @entity158 interference scores over the first 14 days of treatment. Significant improvement was defined as the first day, of >= 2 consecutive days, that @entity4481 significantly (P < 0.05) reduced mean scores compared with placebo. To further quantify timing of therapeutic effect, each treatment group was examined to determine the time required to achieve a >= 1-point improvement in @entity158 and @entity158 interference score among @entity1 with a clinically meaningful and sustained response (>= 30% improvement from baseline to end point) by using a time-to-event analysis method. Kaplan-Meier analyses were used to estimate the median (or 25th quartile) time (in days) required to achieve a >= 1-point improvement, among these responders, in @entity158 and @entity158 interference scores. Comparisons between @entity4481 and placebo were made with a log-rank test. FINDINGS: In both trials, significant improvement of @entity158 and @entity158 interference occurred within 2 days of initiating treatment with @entity4481 . Among @entity1 reporting a clinically meaningful and sustained response to treatment ( @entity1 with >= 30% improvement from baseline to end point), the time to a >= 1-point improvement of @entity158 and @entity158 interference occurred significantly earlier among @entity4481 -treated @entity1 than among placebo-treated @entity1 . Finally, the timing of @entity4481 's effect on @entity158 and @entity158 interference was unaffected by the use of concomitant medications that were allowed for treatment of @entity9 in both trials. IMPLICATIONS: Treatment with @entity4481 results in rapid time to significant improvement in both @entity158 and @entity158 interference in @entity1 with @entity9 due to @entity1566 . These findings should only be used as a guide to physicians and @entity1 as to when clinical response to @entity4481 may be expected.
