Efficacy, tolerability, and safety of oral paliperidone extended release in the treatment of schizophrenia: a 24-week, open-label, prospective switch study in different settings in Taiwan

Figures & data

Table 1 Patient demographics and baseline characteristics

Variable	Mean (SD)
Age (years) (n = 297)	40.1 (10.9)
Age at first onset of psychotic symptoms (years) (n = 276)	25.0 (8.8)
Age at diagnosis of schizophrenia (years) (n = 258)	27.9 (9.7)
Age at first initiation of antipsychotic treatment (years) (n = 263)	27.1 (9.5)
Sex, male, n (%) (n = 297)	137 (46.1)
DSM-IV type, n (%) (n = 297)
Paranoid	217 (73.1)
Disorganized	13 (4.4)
Catatonic	1 (0.3)
Undifferentiated	37 (12.4)
Residual	18 (6.1)
Schizoaffective	6 (2.0)
Missing data	5 (1.7)

Abbreviations: DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, 4th edition; SD, standard deviation.

Figure 1 Mean PANSS total score up to week 24.

Notes: Progressive decrease in the mean PANSS total score in patients with schizophrenia who switched to paliperidone extended release (ER) from baseline to week 24. ITT, n = 297, *p < 0.0001 vs baseline.
Abbreviations: ITT, intention to treat; PANSS, Positive and Negative Syndrome Scale.

Table 2 Mean PANSS Marder factor scores from baseline to week 24

Visit	PANSS Marder factor
	Positive symptoms	Negative symptoms	Disorganized thoughts	Uncontrolled hostility/excitement	Anxiety/depression
Visit 1 (week 0)	21.6 (7.2)	17.0 (7.0)	16.7 (6.6)	7.5 (3.3)	9.7 (3.8)
Visit 2 (week 2)	20.3 (7.4)*	16.2 (6.7)*	15.9 (6.8)*	7.1 (3.4)*	8.7 (3.5)*
Visit 3 (week 4)	19.6 (7.1)*	15.8 (6.7)*	15.7 (6.6)*	6.8 (3.5)*	8.5 (3.5)*
Visit 4 (week 12)	19.6 (7.3)*	15.6 (6.9)*	15.5 (7.3)*	7.0 (3.6)*	8.7 (3.4)*
Visit 5 (week 24)	19.3 (7.5)*	15.3 (7.0)*	15.4 (7.1)*	7.0 (3.9)*	8.5 (3.5)*

Notes: Data are presented as mean (standard deviation); n = 297 for visit 1; n = 281 for visits 2 to 5;

* p < 0.01 versus visit 0.

Abbreviation: PANSS, Positive and Negative Syndrome Scale.

Table 3 Mean PSP scale, GAF scale, and CGI-S scores from baseline to week 24

Week	PSP scale score	GAF scale score	CGI-S score
Week 0	54.5 (13.8) (n = 297)	48.9 (14.7) (n = 273)	4.3 (1.1) (n = 297)
Week 4	56.2 (13.8)* (n = 269)	53.7 (14.3)* (n = 265)	4.1 (1.1)* (n = 279)
Week 12	57.2 (15.1)* (n = 269)	54.8 (15.7)* (n = 265)	4.0 (1.1)* (n = 279)
Week 24	58.0 (15.7)* (n = 269)	55.5 (15.5)* (n = 265)	3.9 (1.2)* (n = 279)

Notes: Data are reported as mean (standard deviation);

* p < 0.01 versus week 0.

Abbreviations: CGI-S, Clinical Global Impression-Severity; GAF, Global Assessment of Functioning; PSP, Personal and Social Performance.

Figure 2 Mean PANSS total score and CGI-S score for patients in medical centers and psychiatric hospitals.

Notes: Mean Positive and Negative Syndrome Scale (PANSS) total score and mean Clinical Global Impression-Severity (CGI-S) score in patients with schizophrenia who switched to paliperidone extended release (ER) grouped by facility type (medical center or psychiatric hospital) at baseline and week 24. Mean scores significantly decreased from baseline only in patients treated at medical centers.

Table 4 Baseline characteristics of patients with schizophrenia treated at medical centers versus psychiatric hospitals

Variable	Medical centers (n = 215)	Psychiatric hospitals (n = 82)	p-value
Age (years)	38.0 (11.5)	45.5 (11.4)	<0.0001
Age at first onset of psychotic symptoms (years)	26.1 (8.9)	22.5 (8.0)	0.003
Age at diagnosis of schizophrenia (years)	28.3 (9.8)	26.5 (9.6)	0.195
Age at start of first initiation of antipsychotic treatment (years)	27.6 (9.5)	25.7 (9.5)	0.168
CGI-S score	3.8 (1.2)	4.3 (1.0)	0.0001
PANSS total score	71.8 (21.5)	74.0 (20.0)	0.435
PSP scale score	54.9 (13.7)	53.3 (14.0)	0.380

Note: Data are reported as mean (standard deviation).

Abbreviations: CGI-S, Clinical Global Impression-Severity; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance.

Table 5 Incidence of AEs with oral paliperidone extended release treatment in all patients

Organ systems	All AEs	Drug-related AEs	Serious AEs	Drug-related serious AEs
Blood and lymphatic system	1 (0.3%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Cardiac	14 (4.7%)	7 (2.4%)	0 (0.0%)	0 (0.0%)
Ear and labyrinth	7 (2.4%)	1 (0.3%)	0 (0.0%)	0 (0.0%)
Endocrine	2 (0.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Eye	13 (4.4%)	2 (0.7%)	0 (0.0%)	0 (0.0%)
Gastrointestinal	57 (19.2%)	20 (6.7%)	0 (0.0%)	0 (0.0%)
General	19 (6.4%)	7 (2.4%)	0 (0.0%)	0 (0.0%)
Hepatobiliary	2 (0.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Immune system	6 (2.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Infections and infestations	54 (18.2%)	1 (0.3%)	1 (0.3%)	0 (0.0%)
Injury, poisoning, and procedural complications	17 (5.7%)	5 (1.7%)	1 (0.3%)	0 (0.0%)
Metabolism and nutrition	17 (5.7%)	6 (2.0%)	0 (0.0%)	0 (0.0%)
Musculoskeletal and connective tissue	37 (12.5%)	11 (3.7%)	0 (0.0%)	0 (0.0%)
Neoplasms*	1 (0.3%)	0 (0.0%)	1 (0.3%)	0 (0.0%)
Nervous system**	97 (33.0%)	71 (23.9%)	1 (0.3%)	1 (0.3%)
Pregnancy, puerperium and perinatal conditions	1 (0.3%)	0 (0.0%)	1 (0.3%)	0 (0.0%)
Psychiatric	119 (40.1%)	54 (18.2%)	5 (1.7%)	1 (0.3%)
Renal and urinary	3 (1.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)

Notes:

* Benign, malignant, and unspecified hepatic malignant neoplasm (including cysts and polyps).

** Among nervous system disorders, the majority of cases were extrapyramidal disorders (13.8%). The mean ± SD ESRS total score with respect to extrapyramidal symptoms significantly improved from 9.31 ± 11.7 at baseline to 8.17 ± 12.0 at the last visit (p < 0.005). Patients, n = 297.

Abbreviations: AE, adverse event; ESRS, Extrapyramidal Symptom Rating Scale; SD, standard deviation.

Figure 3 Paliperidone ER dose distribution for patients in medical centers and psychiatric hospitals.

Note: Differences in distribution of dose of paliperidone extended release (ER) administered to patients with schizophrenia who switched from an other therapy, by facility type (medical center or psychiatric hospital), from baseline to week 24.