Systematic Literature Review of Studies Reporting Measures of Functional Outcome or Quality of Life in People with Negative Symptoms of Schizophrenia.

Aim: Negative symptoms of schizophrenia (NSS) have been linked with poor functional outcomes. A literature review was performed to identify instruments used to assess functional outcomes and quality of life in clinical trials and observational studies conducted in groups of people with NSS. Methods: Literature search strings were designed using Medical Subject Headings combined with free-text terms and searches were performed using the PubMed, Embase and the Cochrane Library databases. For inclusion, articles were required to be published as full-text articles, in English, over the period 2011-2021, include at least one group or treatment arm of people with NSS and report either functional outcomes or quality of life (QoL). Results: Literature searches identified a total of 3,268 unique hits. After two rounds of screening, 37 publications (covering 35 individual studies) were included in the review. A total of fourteen different instruments were used to assess functional outcomes and eleven different instruments were used to assess QoL. In studies in people with NSS, the most frequently used functional outcome measures were the Personal and Social Performance scale and the Global Assessment of Functioning. The most frequently used QoL instruments included the Manchester Short Assessment of Quality of Life, the Heinrich Carpenter Quality of Life Scale, the Schizophrenia Quality of Life Scale and the EQ-5D. Conclusion: A large number of measures have been used to assess functional outcomes and QoL in people with NSS, these include both generic and condition-specific as well as both interviewer-administered and self-reported instruments.

Real-World Evidence of Aripiprazole Tablets with Sensor: Treatment Patterns and Impacts on Psychiatric Healthcare Resource Utilization.

Purpose: Maintaining adherence to antipsychotic (AP) medication is often challenging. Aripiprazole tablets with sensor (AS) contain an ingestible event marker and communicate with wearable patches and a smartphone app to provide objective medication ingestion data. This study evaluated real-world treatment patterns of AS usage and its impact on psychiatric healthcare resource utilization (HCRU). Patients and Methods: This retrospective, observational cohort study identified individuals who initiated AS between 1/1/2019 and 6/30/2020 with 3 months baseline and 6 months of follow-up data using a commercial medical and pharmacy claims database (Clarivate). Controls were propensity score-matched (4:1) to AS initiators based on age (±2 years), sex, diagnosis (major depressive disorder [MDD], schizophrenia, bipolar I disorder [BP-I], other), insurance, and baseline oral AP use (yes/no). Days of AP supply were evaluated using a general regression model. The frequency of psychiatric HCRU during follow-up was compared between groups using a zero-inflated regression model. Results: Most AS initiators were diagnosed with MDD (61.2%) and were women (61.2%); mean age was 37.7 years (standard deviation: 14.1). Most AS initiators (53.1%) continued treatment for >60 days (mean days of supply = 77). After adjusting for covariates, AS initiators had 41% more days of AP supply during follow-up compared with controls (P <0.0001) and significantly lower adjusted odds ratios (ORs) for psychiatric outpatient visits (adjusted OR = 0.80; P <0.05), emergency department visits (adjusted OR = 0.11; P <0.05), inpatient visits (adjusted OR = 0.42; P <0.05), and other medical services (adjusted OR = 0.25; P <0.05). Conclusion: Participants who implemented AS had significantly more days of AP supply and fewer psychiatric care visits. These preliminary results suggest AS usage can help build regular medication-taking habits and holds promise for reducing psychiatric HCRU. Additional studies with larger sample sizes are warranted to inform clinical practice and coverage decisions.

Cost-Effectiveness of Aripiprazole Tablets with Sensor versus Oral Atypical Antipsychotics for the Treatment of Schizophrenia Using a Patient-Level Microsimulation Modeling Approach.

Objective: Strategies designed to track drug ingestion may improve medication adherence and clinical outcomes in adults with schizophrenia. This study aimed to estimate the cost-effectiveness of aripiprazole tablets with sensor (AS; Abilify MyCite®) versus generic oral atypical antipsychotics (AAPs) in schizophrenia from the United States payer and societal perspectives over 12 months. Methods: An individual-level microsimulation was developed to generate individual trajectories using data from a phase 3b multicenter, open-label, mirror-image trial in adults with schizophrenia treated prospectively for 6 months with AS. The patient's clinical characteristics and outcomes were computed as a function of the Positive and Negative Syndrome Scale (PANSS) scores. Direct and indirect medical cost estimates were sourced from the literature; EuroQol 5-Dimensions (EQ-5D) utilities were derived using risk equations based on patient and clinical characteristics. Scenario analyses were also conducted to assess outcomes under the assumption of treatment durability over 12 months. Results: Over 12 months, AS showed a 12.2% improvement in PANSS score. AS had an incremental cost of $2168 and incremental cost savings of $22,343 from the payer and societal perspectives, respectively, with an incremental quality-adjusted life-year (QALY) gain of 0.0298 versus oral AAPs. Further, AS resulted in a 28.2% reduction in hospitalizations over 12 months. At a willingness-to-pay of $100,000 per QALY, the net monetary benefit over 12 months was $25,323 from the payer perspective. Under the assumption of the durability of the treatment effect of AS, the findings were similar to those of the base case analyses, though with greater cost savings and QALYs gained with AS. The results from the sensitivity analyses were consistent with those of the base case analysis. Conclusion: AS may be a cost-effective strategy, with lower costs and improved quality of life among patients with schizophrenia over 12 months, from the payer and societal perspectives.

Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia.

Objective: Inpatient psychiatric admissions drive the financial burden of schizophrenia, and medication adherence remains challenging. We assessed whether aripiprazole tablets with sensor (AS; system includes ingestible event-marker sensor, wearable sensor patches, and smartphone application) could reduce psychiatric hospitalizations compared with oral standard-of-care (SOC) antipsychotics.Methods: This phase 3b, mirror-image clinical trial was conducted from April 29, 2019-August 11, 2020, in adults with schizophrenia with ≥ 1 hospitalization in the previous 48 months who had been prescribed oral SOC for the preceding 6 months (retrospective phase). All participants used AS for at least 3 months and up to 6 months. Primary endpoint was the inpatient psychiatric hospitalization rate in the modified intent-to-treat (mITT; n = 113) population during prospective months 1-3 versus retrospective phase. Proportion of days covered by medication was the secondary endpoint. Safety endpoints included adverse events related to the medication or patch and suicidality.Results: AS significantly reduced hospitalizations during prospective months 1-3 (-9.7%) and months 1-6 (-21.3% [P ≤ .001 for all comparisons]) in the mITT population versus the corresponding retrospective phase. AS use improved confirmed medication ingestion by 26.5 percentage points in prospective months 1-3 (P ≤ .001) and reduced PANSS scores. Patches were well-tolerated, and no participant reported changes in suicide risk.Conclusions: Compared with oral SOC, AS reduced inpatient psychiatric hospitalization rates for adults with mild-to-moderate schizophrenia. The AS system may aid medication ingestion and is associated with improvements in symptoms, potentially reducing acute-care needs among patients with schizophrenia.Trial Registration: ClinicalTrials.gov identifier: NCT03892889.