Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia.

Autor:	Najarian D; Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA., Turkoz I; Janssen Research & Development, LLC, Titusville, New Jersey, USA., Knight RK; Janssen Research & Development, LLC, Titusville, New Jersey, USA., Galderisi S; University of Campania 'Luigi Vanvitelli,' Naples, Italy., Lamaison HF; Department of Psychiatry, National University of La Plata (UNLP), Buenos Aires, Argentina., Zalitacz P; Head of Psychiatric Unit, Gorlice Specialist Hospital, Gorlice, Poland., Aravind S; Janssen Research & Development, LLC, Titusville, New Jersey, USA.; Dural Consulting LLC, St Petersburg, Florida, USA (Dr Aravind)., Richarz U; Janssen Research & Development, Cilag Int., Gubelstrasse, Zug, Switzerland.
Jazyk:	angličtina
Zdroj:	The international journal of neuropsychopharmacology [Int J Neuropsychopharmacol] 2023 Aug 29; Vol. 26 (8), pp. 537-544.
DOI:	10.1093/ijnp/pyad028
Abstrakt:	Background: Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone palmitate 3-month in preventing relapse in patients with schizophrenia in a phase 3 double-blind (DB) study (NCT03345342). Here, we report long-term efficacy and safety results from a 2-year single-arm, open-label extension (OLE; NCT04072575) of this DB study. Methods: Participants who completed the DB study without relapse were enrolled and followed-up every 3 months up to 2 years. Participants received 4 PP6M gluteal injections (700/1000 mg eq.) at baseline, 6-month, 12-month, and 18-month visits. Efficacy endpoints included assessment of relapse, Positive and Negative Syndrome Scale total score, Personal and Social Performance score, and Clinical Global Impression-Severity scale change from baseline. Safety was assessed by treatment-emergent adverse events (TEAEs), physical examinations, and laboratory tests. Results: Of 178 participants enrolled, 154 (86.5%) completed the OLE (mean age: 40.4 years, men: 70.8%; mean duration of PP6M exposure during OLE: 682.1 days). Overall, 7/178 (3.9%) participants relapsed between 20 and 703 days after enrolment. Mean (SD) changes from baseline to endpoint were as follows: Positive and Negative Syndrome Scale total score, 0.7 (8.22); Clinical Global Impression-Severity, 0.0 (0.51); and Personal and Social Performance Scale, 0.5 (7.47). Overall, 111/178 participants (62.4%) reported ≥1 TEAE; most common (>5%) TEAEs were headache (13.5%) and increased blood prolactin/hyperprolactinemia (18.0%); 8/178 (4.5%) participants experienced serious TEAEs, and 6/178 (3.4%) participants withdrew due to TEAEs. No deaths were reported. Conclusions: The relapse rate observed with PP6M during the 2-year OLE was low (3.9%). Clinical and functional improvements demonstrated in the DB study were maintained during OLE, and no new safety concerns were identified. Trial Registration: ClinicalTrials.gov Identifier: NCT04072575; EudraCT number: 2018-004532-30. (© The Author(s) 2023. Published by Oxford University Press on behalf of CINP.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu