Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study

Figures & data

Figure 1 Patients’ disposition.

Abbreviation: ITT, intent-to-treat.

Table 1 Demographic and baseline characteristics (ITT analysis set)

Parameter	All patients (N=212)
Age in years, mean (SD)	37.1 (11.82)
Age range in years	18–64
18–25 years, n (%)	43 (20.3)
26–50 years, n (%)	133 (62.7)
>50 years, n (%)	36 (17.0)
Sex, n (%)
Men	108 (50.9)
Women	104 (49.1)
BMI, kg/m^2, mean (SD)	23.6 (4.24)a
Category, n (%)
Normal weight <25	147 (69.7)
Overweight 25 to <30	47 (22.3)
Obese ≥30	17 (8.1)
Age at first schizophrenia diagnosis, mean (SD) years	29.7 (11.21)
Schizophrenia type, n (%)
Paranoid	149 (70.3)
Disorganized	10 (4.7)
Undifferentiated	50 (23.6)
Residual	3 (1.4)
Baseline PANSS total score, mean (SD)	90.0 (17.41)
Baseline CGI-S score, mean (SD)	4.9 (0.79)
Mild illness, n (%)	6 (2.8)
Moderate illness, n (%)	59 (27.8)
Marked, severe/extremely severe illness, n (%)	147 (69.3)

Note:

a n=211.

Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression-Severity; ITT, intent-to-treat; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Figure 2 Mean (±2 SE) change in PANSS total score from baseline at each timepoint, and at week 13 (ITT analysis set).

Note: *P<0.001 for change from baseline using paired t-test.
Abbreviations: ITT, intent-to-treat; LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale; SE, standard error.

Figure 3 PANSS responder rates at each timepoint and at week 13 (ITT analysis set).

Abbreviations: ITT, intent-to-treat; LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.

Table 2 Change from baseline to each timepoint, and at week 13 in the secondary endpoints (ITT analysis set; LOCF)

Parameter	Baseline mean (SD)	Mean (SD) change from baseline to
		Day 4*	Week 1*	Week 5*	Week 9*	Week 13*
CGI-S score	4.9 (0.79)	ND	−0.6 (0.73)	−1.1 (1.06)	−1.3 (1.28)	−1.4 (1.33)
PSP score	42.8 (13.14)	ND	ND	ND	ND	18.8 (17.56)
PANSS subscales score
Positive subscale score	22.5 (6.53)	−2.1 (3.66)	−4.1 (5.21)	−6.4 (7.08)	ND	−7.7 (7.91)
Negative subscale score	23.1 (7.19)	−1.3 (2.46)	−2.3 (3.78)	−4.1 (5.74)	ND	−5.2 (6.82)
General psychopathology score	44.4 (9.87)	−2.8 (5.29)	−5.6 (7.67)	−8.9 (10.46)	ND	−11.0 (12.20)
PANSS Marder factor scores
Positive symptoms	26.7 (6.27)	−1.7 (3.37)	−3.6 (4.63)	−6.2 (6.66)	ND	−7.7 (7.87)
Negative symptoms	22.7 (7.38)	−1.3 (2.56)	−2.3 (3.99)	−4.0 (5.95)	ND	−5.1 (7.08)
Disorganized thoughts	19.9 (5.44)	−1.2 (2.39)	−2.3 (3.46)	−3.9 (4.74)	ND	−5.0 (5.81)
Uncontrolled hostility and excitement	11.2 (4.11)	−1.2 (2.78)	−2.4 (3.53)	−3.5 (5.01)	ND	−3.9 (5.08)
Anxiety/depression	9.4 (4.07)	−0.7 (1.81)	−1.4 (2.81)	−1.9 (3.19)	ND	−2.3 (3.47)

Note:

* P<0.001 for change from baseline using paired t-test for all parameters.

Abbreviations: CGI-S, Clinical Global Impression-Severity; ITT, intent-to-treat; LOCF, last observation carried forward; ND, not determined; PANSS, Positive and Negative Syndrome Scale; PSP, personal and social performance; SD, standard deviation.

Table 3 Most common (≥2% patients) TEAEs (ITT analysis set)

Parameter	Overall (N=212) n (%)
Patients with at least one TEAE	139 (65.6)
Hyperprolactinemiaa	25 (11.8)
Constipation	19 (9.0)
Nasopharyngitis	18 (8.5)
Insomnia	17 (8.0)
Weight increased	16 (7.5)
Tremor	11 (5.2)
Akathisia	10 (4.7)
Upper respiratory tract infection	10 (4.7)
Injection site pain	9 (4.2)
Sinus bradycardia	9 (4.2)
Anxiety	9 (4.2)
Schizophrenia	8 (3.8)
Extrapyramidal disorder	7 (3.3)
Agitation	6 (2.8)
Diarrhea	6 (2.8)
Hypokalemia	6 (2.8)
Hepatic function abnormal	5 (2.4)
Dystonia	5 (2.4)

Notes:

a Hyperprolactinemia TEAEs also include the preferred terms “blood prolactin increased” and “blood prolactin abnormal”. The percentages are based on the number of patients in the ITT population. Each patient is counted only once within each system organ class and within each preferred term.

Abbreviations: ITT, intent-to-treat; TEAE, treatment-emergent adverse event.