Dieter Naber1, Ross A Baker2, Anna Eramo3, Carlos Forray4, Karina Hansen5, Christophe Sapin6, Timothy Peters-Strickland7, Anna-Greta Nylander8, Peter Hertel9, Simon Nitschky Schmidt10, Jean-Yves Loze11, Steven G Potkin12. 1. Department for Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Wellingsbütteler Landstr 136, 22337 Hamburg, Germany. Electronic address: naber@uke.de. 2. Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: ross.baker@otsuka-us.com. 3. Lundbeck LLC, 4 Parkway North, Deerfield, IL 60015, USA. Electronic address: AERA@lundbeck.com. 4. Lundbeck LLC, 215 College Road, Paramus, NJ 07652, USA. Electronic address: CAFO@Lundbeck.com. 5. Lundbeck SAS, 41-43 Quai du Président Roosevelt, 92445 Issy-les-Moulineaux, France. Electronic address: KHAN@Lundbeck.com. 6. Lundbeck SAS, 41-43 Quai du Président Roosevelt, 92445 Issy-les-Moulineaux, France. Electronic address: CHSA@Lundbeck.com. 7. Otsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: tim.peters-strickland@otsuka-us.com. 8. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark. Electronic address: AGN@lundbeck.com. 9. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark. Electronic address: PHE@lundbeck.com. 10. H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark. Electronic address: SNIS@lundbeck.com. 11. Otsuka Pharmaceutical Europe Ltd., Gallions, Wexham Springs, Framewood Road, Wexham SL3 6PJ, United Kingdom. Electronic address: jyloze@otsuka.fr. 12. Department of Psychiatry and Human Behavior, University of California, Irvine, 5251 California Ave., Suite 240, Mail Code: 1680, Irvine, CA 92617, USA. Electronic address: sgpotkin@uci.edu.
Abstract
OBJECTIVE: To evaluate long-term safety and effectiveness of continued treatment with aripiprazole once-monthly 400mg (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.
OBJECTIVE: To evaluate long-term safety and effectiveness of continued treatment with aripiprazole once-monthly 400mg (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.
Authors: Daniel Schöttle; Wolfgang Janetzky; Daniel Luedecke; Elmar Beck; Christoph U Correll; Klaus Wiedemann Journal: BMC Psychiatry Date: 2020-02-22 Impact factor: 3.630