REXULTI (brexpiprazole) + antidepressant separated from antidepressant + placebo as early as Week 1 and continued to Week 6
NON-PIVOTAL STUDY DATA
Additional analysis
REXULTI® (brexpiprazole) + antidepressant separated from antidepressant + placebo as early as Week 1 and continued to Week 61
The weekly time points prior to Week 6 were not powered for statistical comparison and are descriptive only. Primary endpoint was the mean change from baseline to Week 6 in the MÅDRS total score in the randomization phase.1
aBaseline mean MÅDRS scores were 27.3 for ADT + placebo (n=178) and 26.9 for ADT + REXULTI (n=175).
bp values are based on mixed model repeated-measures analysis.
*p=nominal.
NON-PIVOTAL STUDY DATA
Post hoc analysis
REXULTI® (brexpiprazole) + antidepressant change in MÅDRS total score in adult patients with MDD—with or without symptoms of anxiety
Using pooled data from 3 similarly designed 6-week randomized studies, including both 2 mg and 3 mg doses, changes were evaluated in MÅDRS total score in patients with MDD—with and without symptoms of anxiety.1-3,c,d
Study limitations: These analyses did not assess the effect of treatment on symptoms of anxiety. Patients with anxiety symptoms had a higher MÅDRS total score at baseline and the effects of anxiety and illness severity on outcomes were not differentiated. Statistical adjustments were not made for multiple comparisons, potentially inflating the type 1 error rate.3
Adding REXULTI reduced mean MÅDRS total score by over 2 points in patients with MDD with or without symptoms of anxiety3:
- For patients with symptoms of anxiety, the LS mean change at Week 6 between ADT + REXULTI 2-3 mg/day and ADT + placebo was -2.19 (95% CI: -3.60 to -0.78)
- For patients without symptoms of anxiety, the LS mean change at Week 6 between ADT + REXULTI 2-3 mg/day and ADT + placebo was -2.34 (95% CI: -3.58 to -1.10)
cBaseline demographics and clinical characteristics were similar between treatment subgroups; however, patients with symptoms of anxiety were more likely to be female and have a higher MÅDRS total score at baseline compared with patients without symptoms of anxiety.3
dOf the patients that received an ADT plus REXULTI 2 mg, 3 mg, or placebo, 49% had symptoms of anxiety, defined as a score of ≥7 at baseline on the HAM-D anxiety/ somatization factor.3
ADT, antidepressant treatment; HAM-D, Hamilton Rating Scale for Depression; LS, least squares; MÅDRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depressive disorder; SE, standard error.
Important Warning and Precaution for Cerebrovascular Adverse Events, Including Stroke
In clinical trials, elderly patients with dementia randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease.
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