Elsevier

Schizophrenia Research

Volume 192, February 2018, Pages 205-210
Schizophrenia Research

Long-term effectiveness of aripiprazole once-monthly for schizophrenia is maintained in the QUALIFY extension study,☆☆

https://doi.org/10.1016/j.schres.2017.04.013Get rights and content
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Abstract

Objective

To evaluate long-term safety and effectiveness of continued treatment with aripiprazole once-monthly 400 mg (AOM 400) in patients with schizophrenia.

Methods

Patients who completed the QUALIFY study (NCT01795547) in the AOM 400 arm were eligible for 6 additional once-monthly injections of AOM 400 during an open-label, 24-week extension (NCT01959035). Safety data were collected at each visit. Effectiveness measures included change from baseline in health-related qualify of life and functioning on the Heinrichs-Carpenter Quality of Life scale (QLS) and Clinical Global Impression – Severity (CGI-S) scale.

Results

Of the 88 patients enrolled, 77 (88%) completed the extension study. Most common treatment-emergent adverse events (incidence ≥ 2%) were weight increased (6/88, 7%), toothache (3/88, 3%) and headache (3/88, 3%). Effectiveness was maintained during the extension study, with small but continued improvements from baseline: the least squares mean (LSM) change (95% CI) from baseline to week 24 was 2.32 (− 1.21 to 5.85) for the QLS total score and − 0.10 (− 0.26 to 0.06) for the CGI-S score. The aggregated LSM change (95% CI) from baseline of the lead-in study to week 24 of the extension study was 11.54 (7.45 to 15.64) for the QLS total score and − 0.98 (− 1.18 to − 0.79) for the CGI-S score.

Conclusions

AOM 400 was well tolerated in patients continuing AOM treatment during the extension phase of the QUALIFY study. Robust and clinically meaningful improvements in health-related quality of life and functioning were maintained, further supporting the long-term clinical benefits of AOM 400 for the treatment of patients with schizophrenia.

Keywords

Aripiprazole once-monthly
Schizophrenia
Maintenance treatment
Quality of life

Abbreviations

AE
adverse event
APTS
all-patients-treated set
AOM 400
aripiprazole once-monthly 400 mg
CGI-S
Clinical Global Impressions-Severity
C-SSRS
Columbia Suicide Severity Rating Scale
ECG
electrocardiogram
EPS
extrapyramidal symptoms
FAS
full analysis set
LAI
long-acting injectable
LSM
least squares mean
MMRM
mixed model for repeated measures
PP
paliperidone palmitate
QUALIFY
QUAlity of LIfe with AbiliFY Maintena®
QLS
Quality of Life Scale
QoL
quality of life
TEAE
treatment-emergent adverse event

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Disclosures and acknowledgments: This research was supported by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S. Editorial support for development of this manuscript was provided by Vandana Sharma, PhD, at C4 MedSolutions, LLC (Yardley, PA), a CHC Group company, and funded by Otsuka Pharmaceutical Development & Commercialization, Inc., and H. Lundbeck A/S.

☆☆

Previous presentations: Long-term effectiveness of aripiprazole once-monthly is maintained in the QUALIFY extension study. Naber D, Eramo A, Forray C et al. Presented at: the Schizophrenia International Research Society Annual Scientific Meeting, April 2–4, 2016; Florence, Italy; the American Psychiatric Association Annual Meeting, May 14–18, 2016; Atlanta, GA; the American Society of Clinical Psychopharmacology Annual Meeting, May 30–June 3, 2016; Scottsdale, AZ.