Response Trajectories of Patients with Parkinson’s Disease Psychosis Treated with Pimavanserin: An Exploratory Cluster Analysis
Khashayar Dashtipour1, Alberto Espay2, Peter Zhang3, Victor Abler3, Greg Brunson3, Lambros Chrones3
1Department of Neurology, Loma Linda University School of Medicine, 2University of Cincinnati Gardner Neuroscience Institute, Gardner Family Center for Parkinson’s Disease and Movement Disorders, Department of Neurology, University of Cincinnati, 3Acadia Pharmaceuticals, Inc.
Objective:
To examine the different response trajectories of patients with Parkinson’s disease psychosis (PDP) treated with pimavanserin who share similar patient profiles in baseline characteristics.
Background:
Patients with PDP exhibit great variability in clinical presentation and treatment response, complicating treatment strategies. Understanding this heterogeneity and evaluating response patterns may help to individualize and personalize patient care.
Design/Methods:
Pooled data from 2 phase 3, randomized controlled trials in North America of pimavanserin in PDP underwent input-cluster analysis based on sex, age group, race, Mini-Mental State Examination (MMSE) category, duration of psychosis, and tremor presence. Outcome variables at week 6 included categorized responses on the Clinical Global Impression–Improvement (CGI-I; 1=very much improved, 7=very much worse) and the Scale for the Assessment of Positive Symptoms in Parkinson’s Disease (SAPS-PD; ≥30% reduction=responder, ≥10% to <30%=minimal response, ≥0% to <10%=no change, ≥−30% to <0%=worsening, and <−30%=relapse).
Results:
Among 148 patients in the safety population, 134 had CGI-I data and 134 had SAPS-PD data at week 6. The 5 most commonly identified clusters based on 6 major input variables, including tremor status, ranged from 6 to 23 patients. Of these, the largest group (age 65-75 years, White, male, MMSE ≥25, disease duration ≥12 months, and tremor present) contained 23 (17.16%) patients distributed across 6 of the 7 outcome clusters for CGI-I and all 5 possible outcome clusters for SAPS-PD. Categorized responses “very much improved” and “much improved” on the CGI-I and “responder” on the SAPS-PD were dispersed across nearly all cluster inputs.
Conclusions:
Although many patients from each of the 5 most common input clusters appeared in the improvement/response output clusters, overall, individual clinical outcome trajectories varied. Patients with similar baseline profiles may follow very different response trajectories, further highlighting the heterogeneity in PDP and underscoring the need for more personalized, patient-centered management.
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