Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study

Huafang Li; Yan Li; Yu Feng; Jianmin Zhuo; Ibrahim Turkoz; Maju Mathews; Wilson Tan

doi:10.2147/NDT.S157399

Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study

Neuropsychiatr Dis Treat. 2018 Apr 26:14:1107-1117. doi: 10.2147/NDT.S157399. eCollection 2018.

Authors

Huafang Li^{1

2}, Yan Li^{1

2}, Yu Feng³, Jianmin Zhuo⁴, Ibrahim Turkoz⁵, Maju Mathews⁵, Wilson Tan³

Affiliations

¹ Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.
³ Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore.
⁴ Janssen China Research and Development, Shanghai, China.
⁵ Janssen Research & Development LLC, Titusville, NJ, USA.

Abstract

Purpose: To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate.

Patients and methods: PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18-65 years) diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis.

Results: Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (P≤0.01), PANSS subscales (positive and general psychopathology; all P≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P≤0.01), Personal and Social Performance scale scores (P≤0.05) and Clinical Global Impression-Severity categorical summary (P≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup (P≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups.

Conclusion: Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization.

Keywords: Asian; early treatment initiation; efficacy; hospital discharge; hospital setting; long acting injectable; positive and negative syndrome scale total score; safety.