Key Takeaways
Extended Takeaways
- In the 6-week pooled analysis, functional improvement with brexpiprazole remained significant after removing the PSP disturbing/aggressive behavior domain, suggesting benefit was not solely an artifact of direct improvement in hostility-related behaviors.
- The largest short-term functional separation from placebo was in participants with agitation at baseline, where the modified PSP least squares mean difference was 4.05 (95% confidence interval [CI], 2.01–6.10); P < .001; Cohen d, 0.29 (95% CI, 0.14–0.43).
- Patients without agitation showed only a nonsignificant functional advantage over placebo at Week 6, with a modified PSP least squares mean difference of 2.09 (95% CI, −0.18 to 4.36); P = .071, which may help clinicians set expectations when agitation is not part of the presentation.
- Hostility symptoms were more likely to remit below the predefined threshold by Week 6 with brexpiprazole than placebo, occurring in 218/300 participants (72.7%) versus 105/170 (61.8%), with a relative risk of 1.18 (95% CI, 1.03–1.36); P = .019.
- Agitation response numerically favored brexpiprazole but was not statistically significant over 6 weeks, at 143/345 participants (41.4%) versus 68/200 (34.0%) on placebo, with a relative risk of 1.21 (95% CI, 0.95–1.53); P = .12.
- Among participants who continued brexpiprazole long term, symptom response rates continued to rise, reaching hostility response in 77/85 (90.6%) and agitation response in 86/111 (77.5%) at Week 58, alongside sustained PSP improvement.
