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

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.