Key Takeaways
Extended Takeaways
- Overall discontinuation was higher in Black/African American patients (51.0%) than in White patients (37.6%), Asian patients (23.4%), and patients of other racial groups (18.2%), but this was largely driven by protocol-specified withdrawal criteria rather than adverse events; 15 of 18 Black/African American withdrawals in that category followed a positive drug test.
- Lower adverse event burden in Black/African American participants was not explained by less medication exposure: fewer Black/African American patients received a reduced AOM dose of 300 mg, yet TEAEs were reported in 67.3% versus 81.2% in White patients and 91.5% in Asian patients.
- Weight and metabolic signals did not appear worse in Black/African American patients in this maintenance cohort, with ≥7% weight gain seen in 16.3% (n/N = 17/104) and potentially clinically relevant fasting triglycerides in 29.2% [21/72], both lower than in White patients.
- Functional change may be one of the more clinically meaningful differentiators in this subgroup: the LS mean change in FAST total score at week 52 was −5.97 [95% confidence interval {CI}: −8.82 to −3.13] in Black/African American patients versus −1.89 [95% CI: −3.24 to −0.53] in White patients (P=.0113, Cohen d=0.30).
- Improvements in functioning tracked with mood improvement in Black/African American patients, with correlations of 0.22 (P=.0010) between FAST total score and YMRS total score and 0.34 (P<.0001) between FAST total score and MADRS total score at week 52.
- Interpret efficacy and tolerability results in the context of prior enrichment: patients entered the maintenance phase only after aripiprazole stabilization, so the high stability rate of 90.1% in Black/African American patients reflects maintenance among prior responders and tolerators rather than de novo acute treatment effectiveness.
