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Neuropsychiatric Disease and Treatment Volume 15, 2019 - Issue
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Original Research

Efficacy and safety of paliperidone palmitate 3-month versus 1-month formulation in patients with schizophrenia: comparison between European and non-European population

Adam J Savitz1 Janssen Research & Development, LLC, Raritan, NJ, USA, [email protected]Correspondence[email protected]
,
Haiyan Xu1 Janssen Research & Development, LLC, Raritan, NJ, USA, [email protected]
,
Srihari Gopal1 Janssen Research & Development, LLC, Raritan, NJ, USA, [email protected]
,
Isaac Nuamah1 Janssen Research & Development, LLC, Raritan, NJ, USA, [email protected]
,
Paulien Ravenstijn2 Janssen Research & Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium
,
David Hough1 Janssen Research & Development, LLC, Raritan, NJ, USA, [email protected]
&
Ludger Hargarter3 Medical & Scientific Affairs, Janssen Cilag EMEA, Neuss, Germany
 show all
Pages 587-602 | Published online: 21 Feb 2019

Figures & data

Figure 1 Study design and disposition of patients from Europe, Asia and rest of the world (ITT [OL] analysis set and mITT [DB] analysis set).

Notes: The follow-up visit was 4 weeks after the end-of-study visit for those patients who completed the DB phase without a relapse and 12 weeks for those who withdrew early or had a relapse during the DB phase. In OL phase, patients received PP1M on day 1 (150 mg eq deltoid), day 8 (100 mg eq deltoid), wherein flexible dosing was administered at weeks 5 and 9. PP1M: 50, 75, 100 or 150 mg eq dose; PP3M: 175, 263, 350, 525 mg eq dose (3.5 × PP1M dose).
Abbreviations: DB, double-blind; EU, Europe; OL, open-label; PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month; ROW, rest of the world.
Figure 1 Study design and disposition of patients from Europe, Asia and rest of the world (ITT [OL] analysis set and mITT [DB] analysis set).

Table 1 Analysis sets and number of patients by region/country in the study

Table 2 Demographic and baseline characteristics (ITT [OL] analysis set and mITT [DB] analysis set)

Table 3 Extent of exposure during the double-blind phase by region: Europe vs Asia vs rest of the world (safety analysis set)

Figure 2 Time-to-relapse during the double-blind phase and percentage of patients that remained relapse-free: (A) European patients; (B) Asian patients; (C) rest of the world patients (per-protocol analysis set).

Notes: Based on Kaplan–Meier product limit estimates; per-protocol analysis set defined as patients who were randomly assigned to treatment during the DB phase and received at least 1 dose of DB study drug. Patients did not have any major protocol violations that could impact the efficacy such as violations of eligibility criteria for patient enrollment and randomization, errors in treatment assignment or use of excluded medications.
Abbreviations: DB, double-blind; PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month.
Figure 2 Time-to-relapse during the double-blind phase and percentage of patients that remained relapse-free: (A) European patients; (B) Asian patients; (C) rest of the world patients (per-protocol analysis set).
Figure 2 Time-to-relapse during the double-blind phase and percentage of patients that remained relapse-free: (A) European patients; (B) Asian patients; (C) rest of the world patients (per-protocol analysis set).

Figure 3 Mean (SE) total PANSS score (LOCF) over time: (A) European patients; (B) non-European patients (mITT [DB] analysis set).

Abbreviations: DB, double-blind; OL, open-label; PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month; PANSS, Positive and Negative Syndrome Scale.
Figure 3 Mean (SE) total PANSS score (LOCF) over time: (A) European patients; (B) non-European patients (mITT [DB] analysis set).
Figure 3 Mean (SE) total PANSS score (LOCF) over time: (A) European patients; (B) non-European patients (mITT [DB] analysis set).

Figure 4 Percentage of European patients with (A) symptomatic remission; (B) symptomatic and functional remission over time during the double-blind phase (mITT [DB] analysis set).

Abbreviations: PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month; DB, double-blind.
Figure 4 Percentage of European patients with (A) symptomatic remission; (B) symptomatic and functional remission over time during the double-blind phase (mITT [DB] analysis set).

Table 4 Mean (SD) change from DB baseline in secondary efficacy parameters during the double-blind phase (mITT [DB] analysis set)

Table 5 Summary of treatment-emergent adverse events during the open-label (ITT [OL] analysis set) and double-blind phases (safety analysis set)

Table 6 Body weight, BMI, and waist circumference – change from baseline (OL) to endpoint (DB) – Europe vs non-Europe (Asia, rest of the world and total non-Europe) (safety analysis set)

Table

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