Real-world evidence of pimavanserin utilization among patients with Parkinson's disease psychosis: a review of real-world data that augments data from randomized controlled trials.

Aim: Pimavanserin (PIM) is the only US FDA-approved atypical antipsychotics (AAPs) for the treatment for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). In addition to demonstrating symptom improvements in clinical trials, PIM appears to consistently show favorable outcomes among published real-world evidence (RWE) studies compared with off-label AAPs (e.g., quetiapine [QUE]). A comprehensive review of these RWE studies was conducted to summarize the overall benefits of PIM among PDP patients residing in community or nursing home/long-term care (NH/LTC) settings. Materials & methods: A literature review of published comparative RWE studies of PIM among PDP patients from 1 January 2017 to 1 April 2025 was conducted. Eligible studies examined the following outcomes in community and NH/LTC settings: clinical (e.g., falls, fractures), adherence (e.g., discontinuations), all-cause and psychiatric (psych)-related healthcare resource use (e.g., hospitalizations, emergency room (ER) visits, office visits, etc.), and mortality.

Results

Sixteen RWE studies of PIM versus other-AAPs or QUE and PIM nonusers were included for review. In these studies, PIM had 20-37% lower all-cause and psych-related hospitalizations, 7-15% lower ER visits, significant delays to LTC admissions, lower rates of falls or fractures in NH/LTC settings and lower observed rates of mortality versus other-AAPs. Similar results were found for PIM versus QUE.

Conclusion

PDP patients initiating PIM versus other-AAPs or QUE were associated with lower all-cause and psychiatric healthcare resource use burden, longer community-stays and delayed NH/LTC admissions. Additionally, PIM was associated with higher treatment compliance, fewer falls or fractures and lower overall mortality risk versus other-AAPs or QUE. PIM's favorable real-world profile versus other-AAPs or QUE across community and NH/LTC settings complement the favorable clinical trial findings.