Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia

Joseph P McEvoy, Peter J Weiden, Paul H Lysaker, Xiaowu Sun, Amy K O'Sullivan, Joseph P McEvoy, Peter J Weiden, Paul H Lysaker, Xiaowu Sun, Amy K O'Sullivan

Abstract

Background: This post hoc analysis of clinical trial data evaluated long-term, self-reported mental and physical health-related quality of life (HRQoL) scores in schizophrenia patients receiving aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults.

Methods: The study population included 291 stable schizophrenia outpatients enrolled in 2 consecutive long-term safety studies of AL given every 4 weeks for up to 124 weeks. HRQoL was measured using the SF-36v2® Health Survey (SF-36v2) over the course of the follow-up. The primary outcome was change in SF-36v2 mental component summary (MCS) and physical component summary (PCS) scores from baseline to 124 weeks. To contextualize these scores, descriptive analyses were conducted to compare the scores with available scores for the general population as well as for other populations with chronic medical (ie, hypertension and type 2 diabetes) or psychiatric (ie, depression) conditions.

Results: Results from this post hoc analysis indicated that the mean MCS score for patients continuing AL improved significantly from baseline over 124 weeks (P < .05, all timepoints), while mean PCS score showed little change over 124 weeks. At baseline, patients had lower (worse) MCS scores than the normed general population, but by week 124, patients had MCS scores comparable to those in the general population. This pattern of change was not observed with PCS scores. Comparison of study MCS scores with those associated with other diseases showed that this schizophrenia cohort had lower scores than those with chronic medical conditions but higher scores than those with depression. PCS scores were higher in the study population than published scores for all reference populations at baseline and week 124.

Conclusions: In this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression.

Trial registration: ClinicalTrials.gov (NCT01626456 [trial registration date: June 15, 2012] and NCT01895452 [trial registration date: July 5, 2013]).

Keywords: Aripiprazole lauroxil; Health-related quality of life; Long-acting injectable antipsychotics; Patient-reported outcomes; SF-36v2; Schizophrenia.

Conflict of interest statement

At the time of the study, Drs. Sun, Weiden, and O’Sullivan were employees of Alkermes, Inc., and may own stock in the company. Drs. McEvoy and Lysaker have received consulting fees from Alkermes, Inc., in the past.

Figures

Fig. 1
Fig. 1
Patient timeline and disposition. aNasrallah HA, et al. [17]. bThe week 0 timepoint corresponds with baseline for this analysis
Fig. 2
Fig. 2
Longitudinal mental and physical HRQoL. Data are least squares mean estimates of change from baseline (ie, week 0); timepoints are not shown to scale. aAfter 52 weeks, patients switched to the long-term extension study and completed the SF-36v2 every 12 weeks. *P < .05 vs week 0 baseline. BL, baseline; HRQoL, health-related quality of life; MCS, mental component summary score; PCS, physical component summary score; SF-36v2, SF-36v2 Health Survey
Fig. 3
Fig. 3
Trajectory of self-reported HRQoL during continuation treatment with aripiprazole lauroxil. aAfter 52 weeks, patients completed the SF-36v2 every 3 months, where 1 month = 28 days − 7/+ 14 days. HRQoL, health-related quality of life; MCS, mental component summary score; PCS, physical component summary score; SF-36v2, SF-36v2 Health Survey
Fig. 4
Fig. 4
Baseline and follow-up schizophrenia mental health HRQoL (mean MCS scores) compared with other chronic conditions. a95% CIs are presented for AL means only; 95% CIs were not available for the other populations. Orange dotted lines indicate minimal important differences relative to the general population mean for MCS scores. AL, aripiprazole lauroxil; HRQoL, health-related quality of life; MCS, mental component summary score; SF-36v2, SF-36v2 Health Survey. Data for type 2 diabetes, hypertension, and depression are from Maruish et al. [19]

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