Long-Term Health Outcomes in Patients with Schizophrenia Treated with the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for 1 Year

Author(s)

Gasper SM, Dingman S, Wang M, Roy BD
Alkermes, Inc., Waltham, MA, USA

OBJECTIVES: Long-term safety and efficacy of the long-acting injectable antipsychotic aripiprazole lauroxil (AL) in patients with schizophrenia previously were reported based on a phase 3, 52-week, open-label extension (OLE; NCT01626456). The objective of this prespecified analysis was to assess health outcomes using the EuroQol Group Health Outcome Measure-five level (EQ-5D-5L) in patients who remained on AL for up to 1 year.

METHODS: Adult patients with schizophrenia who had completed a 12-week AL trial or were clinically stable on oral antipsychotic medication were assigned to AL (441mg or 882mg monthly) for 52 weeks. Patients scored EQ-5D-5L health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5-level scale, (“no problems” to “extreme problems”). Proportions of patients giving each response were summarized by dimension at 1-month and 1-year timepoints.

RESULTS: In total, 478 patients enrolled in the OLE; 462 patients were included in the EQ-5D-5L analysis, and 325 patients had an EQ-5D-5L assessment at 1 year. At 1 month, the proportion of patients reporting “no problems” or “slight problems” was ≥90% for each dimension (mobility, 93.3%; self-care, 95.7%; usual activities, 93.1%; pain/discomfort, 91.6%; anxiety/depression, 89.8%) and the proportion reporting “no problems” ranged from 61.0% (anxiety/depression) to 85.1% (self-care). At 1 year, the proportion of patients reporting “no problems” or “slight problems” for each dimension had numerically increased (mobility, 95.0%; self-care, 96.0%; usual activities, 94.1%; pain/discomfort, 95.4%; anxiety/depression, 94.5%); the proportion reporting “no problems” ranged from 74.8% (anxiety/depression) to 90.2% (self-care).

CONCLUSION: The majority of patients with stable schizophrenia reported “no problems” or “slight problems” over 5 health outcome dimensions after 1 month of OLE treatment with AL. The proportion of patients with “no problems” or “slight problems” was even greater after 1 year of AL treatment, indicating that long-term consistent treatment is associated with improvements in self-reported health-related quality of life.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA

Value in Health, Volume 25, Issue 6, S1 (June 2022)

Code

CO58

Topic

Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research, Study Approaches

Topic Subcategory

Clinical Outcomes Assessment, Clinical Trials, Health State Utilities, PRO & Related Methods

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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