4 results
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
-
- Journal:
- CNS Spectrums / Volume 28 / Issue 2 / April 2023
- Published online by Cambridge University Press:
- 14 April 2023, pp. 252-253
-
- Article
-
- You have access Access
- Export citation
-
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
Study Outcomes Among Patients with Parkinson’s Disease Treated for Psychosis Residing in the Long-Term Care Setting and Newly Initiating Pimavanserin or Off-Label Atypical Antipsychotics
- Juliana Meyers, Tram Nham, Stanley Wang, Lizzi Esterberg, Nazia Rashid
-
- Journal:
- CNS Spectrums / Volume 28 / Issue 2 / April 2023
- Published online by Cambridge University Press:
- 14 April 2023, p. 253
-
- Article
-
- You have access Access
- Export citation
-
Introduction
Psychosis is a common feature of Parkinson’s Disease (PD), with an estimated 50% of PD patients experiencing psychosis (i.e., hallucinations [H] or delusions [D]) at some time during the course of their illness. Pimavanserin (PIM) is the only medication approved in the US for the treatment of H&D associated with Parkinson’s disease psychosis (PDP); however, off-label atypical antipsychotics (AAP) are continuously used. Currently, there are very few real-world studies which evaluate the patient characteristics and clinical outcomes among PD patients residing in the long-term care (LTC) setting within the US, newly initiated on PIM or other AAPs to treat psychosis.
MethodsA national LTC database consisting of diagnoses (DX), pharmacy orders (RX), and EHR data linked with the Minimum Data Set (MDS) was used to identify PD patients with a PD DX and 1 PD RX from 01/01/2017 to 09/30/2021 retrospectively. Patient groups were created: PIM group (patients with a PIM RX); AAP group (patients with an AAP RX [and no PIM RX]); and no treatment (No Tx) group (no PIM or AAP RX). All patients were required to have at least 100 days in LTC to be labelled as a resident (≤7 days between discharge and admission were included as LTC stay). Psychosis diagnosis was required at any time for the AAP and No Tx groups. Other medical causes of psychosis beyond PD were not excluded. The index dates were the first RX identified during the study time period for the PIM and AAP groups; and the psychosis DX date for the No Tx group. Incident treatment patients were defined as having no history of PIM or AAP in the 6 months prior to the index date. Patient/clinical characteristics, treatment patterns, and study outcomes were reported using means (SD) and frequencies during the post index period.
ResultsThere were: PIM group (N=3,120; N=870 incident), AAP group (N=5,880; N=2,396 incident), and No Tx group (N=1,802). The PIM and AAP groups had an average of 415 days and 383 days between the admitting date and the date of RX. The mean age among all groups was 76–77 years and 48–50% were female. PIM group patients were observed to be sicker with higher rates of concomitant dementia, depression, diabetes, and hypertension versus the AAP group or No Tx group. Initial treatments in the AAP group were mostly quetiapine (49%), risperidone (21%), or olanzapine (12%). The descriptive analysis during the 6 months post index showed the outcomes for the incident AAP group to have: higher proportion of falls and aggression events; higher incidence of new DX (physical changes, anxiety disorders, cognitive decline, insomnia, depression, and anticholinergic effects); and higher proportion of new medication orders (anticonvulsants, antidepressants, and benzodiazepines) compared with the incident PIM group.
ConclusionsIn this descriptive LTC retrospective analysis, incident PIM patients were shown to have better outcomes versus the AAP group. These findings are subject to study limitations.
FundingAcadia Pharmaceuticals Inc.
Economic Burden of Dementia Related Psychosis Among Medicare Beneficiaries: A State-Transition Markov Analysis of Total Annual Direct Costs
- Kinpritma Sangha, Nazia Rashid, Victor Abler, Krithika Rajagopalan
-
- Journal:
- CNS Spectrums / Volume 26 / Issue 2 / April 2021
- Published online by Cambridge University Press:
- 10 May 2021, p. 161
-
- Article
-
- You have access Access
- Export citation
-
Study Objective
Dementia related psychosis (DRP), characterized by debilitating symptoms such as hallucinations and delusions, is estimated to affect 2.4M people with dementia in the US. Patients with DRP may have twice the rate of dementia progression compared to patients with no DRP. Given that dementia disproportionally impacts the elderly, a comprehensive cost of-illness analysis may add to the current understanding of the overall economic burden of DRP prevalence. The objective of this study was to estimate the cost of DRP from a Centers for Medicare and Medicaid Services (CMS) perspective.
MethodsA five state-transition Markov analysis, adapted from Green et al, was conducted to assess the annual direct DRP cost burden to CMS. Patients entering the model were allowed to transition between three at-home health-states (mild dementia plus psychosis, moderate dementia plus psychosis, severe dementia plus psychosis), one long-term care/nursing home (LTC/NH) stay, or death (absorbent health state) at any given time. Since the model accommodates tunnel health-states based on dementia, psychosis and functioning severity levels, patients stayed in the same health-state or transitioned to a more severe health-state or progressed to death (i.e., absorbent health-state) between each 30-day cycle. Prevalence, disease-severity, and state-transition probability estimates were derived from literature while direct costs of DRP were derived from a Medicare claims analysis. Costs were discounted at 3%. Model robustness was tested to check if results were sensitive to changes in inputs and assumptions.
ResultsOf the estimated 61.5M Medicare beneficiaries, about 6.87M may suffer from dementia. In the base-case scenario, an estimated total of 2.2M prevalent DRP patients enter the model based on dementia severity into one of the 4 non-absorbent health-states: three at-home (10% mild, 60% moderate, and 10% severe) and one LTC-NH (10%). Total Medicare annual direct DRP costs are estimated to be approximately $119.98B ($113.96B-$125.96B) and about $54K PPPY (Per-Patient-Per-Year) costs (2019 USD). NH costs and patient volume at higher severity levels are significant cost drivers. Sensitivity analysis results show that the model is sensitive to disease severity and disease progression.
ConclusionsThese results suggest that DRP imposes a significant direct cost burden despite its low prevalence. In this analysis, per-patient per year (PPPY) cost of DRP prevalence was estimated to be slightly higher than incident PPPY DRP costs. These differences may be attributed to the number of patients at higher severity levels and the time spent in a severe health state as well as cost of LTC/NH stays. Especially given the ageing population in the US, DRP could become an increasing public health concern. There is a significant need for education and awareness about DRP cost burden.
FundingAcadia Pharmaceuticals Inc.
433 - Burden of Disease Associated with Dementia-related Psychosis and Dementia-related Agitation & Aggression Using a National Long-term Care US Database
- Nazia Rashid, Sherry Andes, Vic Abler, Leslie Citrome
-
- Journal:
- International Psychogeriatrics / Volume 32 / Issue S1 / October 2020
- Published online by Cambridge University Press:
- 04 November 2020, pp. 149-150
-
- Article
-
- You have access Access
- Export citation
-
Objective: Compare burden of disease among patients with dementia-related psychosis (DRP), dementia without psychosis (dementia only), and dementia-related agitation/aggression (DAA) in long-term care (LTC) facilities.
Background: Patients with dementia often experience neuropsychiatric symptoms (NPS), including psychosis and agitation/aggression. Real-world data on the comorbidity profile of DRP and DAA patients are limited.
Design/Methods: Dementia patients were identified from a US LTC database based on ?2 dementia diagnosis codes or 1 dementia diagnosis code and antidementia therapy prescription during 1 Jan 2013 to 30 May 2017. Patients were categorized into DRP (?2 psychosis or 1 psychosis diagnosis code and prescription of antipsychotic therapy and no history of agitation/aggression diagnosis), dementia only (no psychosis or agitation/aggression diagnosis and no history of antipsychotic therapy [dementia only]), and DAA (?2 diagnosis codes of agitation/aggression and no history of psychosis diagnosis or antipsychotic therapy) groups (index date). Comorbidities and concomitant therapies were defined during 12 months prior to index date.
Results: There were 26,002 dementia residents: DRP (n=11,921; 46%); dementia only (n=11,432; 44%); DAA (n=2649; 10%). DRP patients were younger (mean age 80.8 years) than dementia only (84.3 years) or DAA (83.8 years). DRP patients were sicker overall versus dementia only: anemia (32% vs 29%); anxiety (55% vs 33%); bladder disorders (19% vs 13%); depression (75% vs 58%); hypertension (43% vs 33%); diabetes (43% vs 38%); insomnia disorders (32% vs 19%); (all P<0.05). More DAA patients had anxiety (43%), depression (66%), hypertension (43%), and insomnia disorders (26%) than dementia only (all P<0.05). Most DRP patients (94.3%) received off-label treatment for DRP; approximately one third (31.6%) of DAA patients received off-label treatment for DRP.
Conclusions: This study, the first of its type to use a US LTC database, demonstrated a significant comorbidity burden associated with DRP or DAA compared with dementia only, which should be considered when using off-label treatments. These data highlight the need for safe and effective treatments for dementia NPS.
Study Sponsored By: ACADIA Pharmaceuticals Inc.
DisclosuresNR, SA, VA are employees of ACADIA Pharmaceuticals
LC has served as a consultant, speaker, holds stock in, or receives royalties from: Acadia, Alkermes, Allergan, Avanir, BioXcel, Eisai, Impel, Indivior, Intra -Cellular Therapies, Janssen, Lundbeck, Luye, Merck, Neurocrine, Noven, Osmotica, Otsuka, Pfizer, Sage, Shire, Sunovion, Takeda, Teva, Vanda, Bristol-Myers Squibb, Eli Lilly, J & J; Wiley (Editor-in-Chief, International Journal of Clinical Practice), UpToDate (reviewer), Springer Healthcare (book)
This submission is an encore of a poster abstract originally presented at ISPOR 2019, New Orleans, LA, USA, May 18–22, 2019; original presentation under the same title.