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Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations.
Turkoz, Ibrahim; Daskiran, Mehmet; Siddiqui, Uzma; Knight, R Karl; Johnston, Karen L; Correll, Christoph U.
Afiliação
  • Turkoz I; Janssen Research & Development, LLC, Titusville, NJ, USA.
  • Daskiran M; Janssen Research & Development, LLC, Titusville, NJ, USA.
  • Siddiqui U; Janssen Research & Development, LLC, Titusville, NJ, USA.
  • Knight RK; Janssen Research & Development, LLC, Titusville, NJ, USA.
  • Johnston KL; Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
  • Correll CU; Zucker Hillside Hospital, Department of Psychiatry, Glen Oaks, New York, USA.
Int J Neuropsychopharmacol ; 27(2)2024 Feb 01.
Article em En | MEDLINE | ID: mdl-38300235
ABSTRACT

BACKGROUND:

The 3 paliperidone palmitate (PP) long-acting injectable antipsychotic formulations, PP 1-month (PP1M), PP 3-month (PP3M), and PP 6-month (PP6M), have shown to reduce the risk of relapse in schizophrenia. The current phase-4 study constructed external comparator arms (ECAs) using real-world data for PP3M and PP1M and compared relapse prevention rates with PP6M from an open-label extension (OLE) study in adult patients with schizophrenia.

METHODS:

PP6M data were derived from a single-arm, 24-month, OLE study (NCT04072575), which included patients with schizophrenia who completed a 12-month randomized, double-blind, noninferiority, phase-3 study (NCT03345342) without relapse. Patients in the PP3M and PP1M ECAs were identified from the IBM® MarketScan® Multistate Medicaid Database based on similar eligibility criteria as the PP6M cohort.

RESULTS:

A total of 178 patients were included in each cohort following propensity score matching. Most patients were men (>70%; mean age 39-41 years). Time to relapse (primary analysis based on Kaplan-Meier estimates) was significantly delayed in the PP6M cohort (P < .001, log-rank test). The relapse rate was lower in the PP6M cohort (3.9%) vs PP3M (20.2%) and PP1M (29.8%) cohorts. Risk of relapse decreased significantly (P < .001) by 82% for PP6M vs PP3M (HR = 0.18 [95% CI = 0.08 to 0.40]), 89% for PP6M vs PP1M (HR = 0.11 [0.05 to 0.25]), and 35% for PP3M vs PP1M (HR = 0.65 [0.42 to 0.99]; P = .043). Sensitivity analysis confirmed findings from the primary analysis. Although the ECAs were matched to mimic the characteristics of the PP6M cohort, heterogeneity between the groups could exist due to factors including prior study participation, unmeasured confounders, variations in data capture and quality, and completeness of clinical information.

CONCLUSIONS:

In a clinical trial setting, PP6M significantly delayed time to relapse and demonstrated lower relapse rates compared with PP3M and PP1M treatments in real-world settings among adult patients with schizophrenia. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04072575; EudraCT number 2018-004532-30.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esquizofrenia / Antipsicóticos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Male País/Região como assunto: America do norte Idioma: En Revista: Int J Neuropsychopharmacol Assunto da revista: NEUROLOGIA / PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esquizofrenia / Antipsicóticos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Adult / Female / Humans / Male País/Região como assunto: America do norte Idioma: En Revista: Int J Neuropsychopharmacol Assunto da revista: NEUROLOGIA / PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos