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A Prospective Observational Study Examining the Real-World Clinical and Treatment Outcomes of Parkinson’s Disease Psychosis in the United States
- Jennifer G. Goldman, Jeffrey P. Trotter, Niccole Larsen, Dilesh Doshi, Nazia Rashid
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- Journal:
- CNS Spectrums / Volume 28 / Issue 2 / April 2023
- Published online by Cambridge University Press:
- 14 April 2023, pp. 252-253
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Introduction
Psychosis is a common feature of Parkinson’s Disease (PD), affecting approximately 50% of PD patients during their disease course. The INSYTE study was the first prospective, real-world, observational study examining the outcomes of both treated and untreated patients with PD Psychosis (PDP).
MethodsPDP patients were enrolled from 76 US academic centers and community sites from 03/21/2017 to 03/08/2021. Patients were included in the final analytical cohort if they had a baseline visit and at least 1 follow-up visit within 3 years; due to the variability of follow-up for each patient within the 3-year period, all study outcomes were assessed in patients with at least one baseline and two follow-up visits within 1 year. No specific visit schedule was imposed; all interactions were established by the investigators. Questionnaires were completed at follow-up visits and assessments focused on PDP treatment utilization, treatment patterns, clinical outcomes, caregiver burden, quality of life, and resource utilization.
Results760 patients were initially enrolled; 635 patients (84%) were included in the final study group, and 441 patients (69%) were included in the analysis. 281 patients (64%) had no antipsychotic treatment at enrollment (untreated group) vs 160 (36%) who had received an antipsychotic at enrollment (treated group). At enrollment, patients in the untreated vs treated group, respectively, had a mean PD duration of 8.05 vs 10.23 years, mean duration of PDP features of 2.20 vs 3.10 yrs, and had a PDP diagnosis for a mean of 1.42 vs 2.16 yrs. Most patients in the untreated group (n=221, 77%) received no antipsychotics through follow-up. The groups were balanced in terms of age (mean 73.9 vs 73.4 yrs) and sex (65.1% vs 63.1% male). The untreated group had higher rates of hypertension (44.5% vs 36.8%) and diabetes (12.8% vs 8.8%); however, the treated group had higher rates of depression (25.6% vs 41.3%) and anxiety (22.8% vs 26.9%). The percent change from baseline at 12 months in total psychosis, hallucination, and delusion scores for the untreated group showed greater worsening than the treated group: 32.3% vs 29.3%; 29.3 % vs 25.0%; and 29.3 % vs 25.0%, respectively, as did daytime sleepiness scores (51.6% vs 40.8%). Measures of PD severity (non-motor and motor MDS-UPDRS scores) and health-related quality of life showed less worsening for the untreated group vs treated group at 12 months. Caregiver burden (per the ZBI) was lower in the untreated group vs the treated group (81.5% vs 90.0%).
ConclusionsIn this descriptive analysis, untreated patients had shorter duration of PD, fewer PDP symptoms at baseline, and lower rates of mental health comorbidities vs treated patients. The untreated PDP patients had greater worsening in their psychosis and sleepiness scores at 12 months versus the treated group, yet remained untreated. Future studies are needed to better understand clinicians’ rationale for withholding PDP treatment.
FundingAcadia Pharmaceuticals, Inc
107 Examining Real World Treatment Pathways in Parkinson Disease Psychosis: Initial Findings from the INSYTE Observational Study
- Jennifer G. Goldman, Susan H. Fox, Bruce Coate, Jesse LoVerme, Niccole J. Larsen, Jeff Trotter, Andrew Shim
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- Journal:
- CNS Spectrums / Volume 25 / Issue 2 / April 2020
- Published online by Cambridge University Press:
- 24 April 2020, pp. 269-270
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Study Objectives:
The INSYTE study provides an understanding of the management of Parkinson disease psychosis (PDP) in actual practice settings, including use of antipsychotic (APs) and their impact on clinical, economic, and humanistic outcomes. Treatment paradigms or the benefits/consequences of various “real world” PDP treatment strategies have not been evaluated. Thus, providers may be using a wide range of AP treatment strategies that contrast with consensus recommendations.
Method:The INSYTE study is enrolling up to 750 patients from up to 100 sites in the US. Data are compiled at the baseline (BL) visit and from standard-of-care follow up visits over 3 years. PDP treatment pathways are defined from 3 BL cohorts reflecting (1) no AP medication, (2) use of pimavanserin (PIM), or (3) other AP treatment. Information about APs used is collected at each follow-up visit: history, duration, dose, adjustment, and rationale for adjustment of treatment. Outcomes assessments (clinical, quality of life, disease burden) by the physician, patient, and caregiver are also collected. AP medication and outcomes data are analyzed for patients completing a BL and 1 follow up visit (FU1).
Results:For 404 patients with BL and FU1 visits (mean 120.7 days from BL), 56.8% used no AP medications, 26.0% used PIM, and 13.6% used other APs at BL. The No Medication group was noted to be less severe in key BL disease parameters. Considering primary PDP treatments at BL and FU1 (including no treatment), 26 distinct pathways were being employed. 12.6% of patients had AP medication adjustments between BL and FU1 visits, most frequently from the non-PIM group. Adjustments of APs occurred in many forms: introduction of a single AP (64.7%%), introduction of multiple APs (5.9%), switching to another AP (3.9%), decreasing the number of APs (5.9%), and discontinuation (19.6%).
Conclusions:Multiple, divergent AP treatment strategies for PDP exist in actual practice. No identifiable BL characteristics correlated with the broad range of AP treatment pathways. The numerous distinct AP treatment pathways utilized (n=26) reflect discordance with the updated 2019 MDS evidence-based recommendations, which recognize only 2 APs as “efficacious” and “clinically useful”: pimavanserin and clozapine. Education of healthcare professionals remains a priority for PDP management.
Funding Acknowledgements:ACADIA Pharmaceuticals Inc.