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

Dean Najarian; Ibrahim Turkoz; R Karl Knight; Silvana Galderisi; Hector F Lamaison; Piotr Zalitacz; Suresh Aravind; Ute Richarz

doi:10.1093/ijnp/pyad028

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

Int J Neuropsychopharmacol. 2023 Aug 29;26(8):537-544. doi: 10.1093/ijnp/pyad028.

Authors

Dean Najarian¹, Ibrahim Turkoz², R Karl Knight², Silvana Galderisi³, Hector F Lamaison⁴, Piotr Zalitacz⁵, Suresh Aravind^{2

6}, Ute Richarz⁷

Affiliations

¹ Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
² Janssen Research & Development, LLC, Titusville, New Jersey, USA.
³ University of Campania "Luigi Vanvitelli," Naples, Italy.
⁴ Department of Psychiatry, National University of La Plata (UNLP), Buenos Aires, Argentina.
⁵ Head of Psychiatric Unit, Gorlice Specialist Hospital, Gorlice, Poland.
⁶ Dural Consulting LLC, St Petersburg, Florida, USA (Dr Aravind).
⁷ Janssen Research & Development, Cilag Int., Gubelstrasse, Zug, Switzerland.

Abstract

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.

Keywords: Long-term efficacy; long-acting injectable; open-label extension; paliperidone palmitate 6-month; schizophrenia.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Double-Blind Method
Humans
Male
Paliperidone Palmitate* / adverse effects
Schizophrenia* / drug therapy

Substances

Paliperidone Palmitate

Associated data

ClinicalTrials.gov/NCT04072575
ClinicalTrials.gov/NCT03345342
EudraCT/2018-004532-30