Clinical Summary: Safety and Efficacy of Maintenance Treatment With Aripiprazole Once-Monthly in Black/African American Adults Diagnosed With Bipolar I Disorder: Post Hoc Analysis of a 52-Week, Open-Label Study
Black/African American patients with bipolar I disorder are more likely to receive antipsychotics, often at higher doses and more often as first-generation agents, yet evidence on second-generation long-acting injectables in this population is sparse. This analysis addresses that gap by examining whether aripiprazole once-monthly 400 mg maintains stability and has a comparable safety profile in Black/African American adults already stabilized on aripiprazole.
Key Findings
- A high proportion of Black/African American patients remained stable at the last visit (90.1%), similar to White patients (87.4%), Asian patients (91.5%), and patients of other racial groups (90.9%).
- The incidence of TEAEs was lower in Black/African American patients (67.3%) than in White patients (81.2%), Asian patients (91.5%), and patients of other racial groups (100%).
- The LS mean change in FAST total score from baseline to week 52 was greater in Black/African American patients than in White patients: −5.97 [95% confidence interval {CI}: −8.82 to −3.13] versus −1.89 [95% CI: −3.24 to −0.53], P=.0113, Cohen d=0.30.
- Improvement in functioning in Black/African American patients correlated with improvement in mood scores at week 52: the correlation was 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.
- Black/African American patients had ≥7% weight gain at any time point in 16.3% (n/N = 17/104), compared with 21.6% (55/255) in White patients, 17.0% (16/94) in Asian patients, and 45.5% (5/11) in patients of other races.
In Black/African American adults with bipolar I disorder already stabilized on aripiprazole, AOM 400 maintained stability over 52 weeks with no signal of worse tolerability than in other racial groups. The data support considering second-generation LAI treatment in this population rather than defaulting to race-based prescribing patterns.
Practice Implications
- Consider AOM 400 as a maintenance option for Black/African American patients with BP-I who have been stabilized on aripiprazole; 90.1% remained stable at the last visit in this cohort.
- Do not assume higher EPS or adverse-event burden in Black/African American patients receiving AOM 400; TEAEs occurred in 67.3%, and changes in EPS rating scale scores were minimal and not clinically meaningful across racial groups.
- Monitor weight and metabolic parameters routinely, but this analysis did not show worse weight gain in Black/African American patients; ≥7% weight gain occurred in 16.3% (17/104), and potentially clinically relevant fasting triglycerides occurred in 29.2% (21/72).
- Interpret the high maintenance success in context: patients were stabilized on aripiprazole before the maintenance phase, so these results are most applicable to prior responders and tolerators rather than to acute de novo treatment decisions.
