Efficacy, safety, and impact on hospitalizations of paliperidone palmitate in recent-onset schizophrenia

Figures & data

Table 1 Baseline demographics and clinical characteristics of patients recently diagnosed with schizophrenia (intent-to-treat population)

Parameters	Paliperidone palmitate (N=521)
Age (years), mean (SD)	28.7 (7.95)
Weighta (kg), mean (SD)	68.4 (16.82)
Sex, n (%)
Men	341 (65.5)
Women	180 (34.5)
Race, n (%)
Asian	482 (92.5)
White	31 (6.0)
African American	3 (0.6)
Native Hawaiian or other Pacific Islander	1 (0.2)
Other	4 (0.8)
Schizophrenia type, n (%)
Paranoid	387 (74.3)
Undifferentiated	86 (16.5)
Disorganized	28 (5.4)
Residual	20 (3.8)
Elapsed time since first diagnosis by yearly interval, n (%)
0 to <1	191 (36.7)
1 to <2	82 (15.7)
2 to <3	86 (16.5)
3 to <4	89 (17.1)
≥4	73 (14.0)
Prior antipsychotic use, n (%)	323 (62.0)
PANSS baseline total score,a mean (SD)	64.1 (19.09)
PANSS baseline total score categories,a n (%)
<70	332 (63.7)
≥70	188 (36.1)
CGI-SCH baseline overall severity score,a n (%)
<4	283 (54.3)
≥4	237 (45.5)
Prior psychiatric hospitalizations (2 years before baseline), n (%)
None	334 (64.1)
At least once	187 (35.9)

Note:

a n=520.

Abbreviations: CGI-SCH, Clinical Global Impression of Schizophrenia; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Figure 1 Change from baseline to month 18 in primary efficacy parameter (intent-to-treat population; LOCF).

Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the null hypothesis that change is ≥−3.
Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.

Figure 2 Change from baseline to month 18 in PANSS total score by PANSS baseline total score categories (intent-to-treat population; LOCF)

Notes: **Compared with baseline, P<0.0001. P-value is from one-sided paired t-test for the null hypothesis that change is ≥−3.
Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale.

Table 2 Changes from baseline to month 18 in secondary efficacy parameters (intent-to-treat population; LOCF)

Secondary efficacy parameters	Paliperidone palmitate (N=521)
PANSS factor scores,a mean (SD)
Positive symptoms
Baseline	18.7 (6.94)
Change from baseline	−3.8 (7.65)*
Negative symptoms
Baseline	16.9 (7.01)
Change from baseline	−3.0 (6.19)*
Disorganized thoughts
Baseline	14.0 (4.86)
Change from baseline	−2.2 (5.30)*
Uncontrolled hostility/excitement
Baseline	6.7 (3.43)
Change from baseline	−1.1 (3.69)*
Anxiety/depression
Baseline	7.7 (3.13)
Change from baseline	−1.2 (3.45)*
CGI-SCH score,b mean (SD)
Positive symptoms
Baseline	3.1 (1.40)
Change from baseline	−0.8 (1.57)*
Negative symptoms
Baseline	3.0 (1.23)
Change from baseline	−0.6 (1.14)*
Depressive symptoms
Baseline	1.9 (0.99)
Change from baseline	−0.3 (1.08)*
Cognitive symptoms
Baseline	2.6 (1.13)
Change from baseline	−0.4 (1.19)*
Overall severity
Baseline	3.4 (1.10)
Change from baseline	−0.8 (1.35)*
MSQ scores,c mean (SD)
Baseline	4.3 (1.31)
Change from baseline	0.8 (1.90)*

Notes: A reduction in PANSS and CGI-SCH scores from baseline represents improvement. An increase in MSQ score from baseline indicates improvement.

a n=510,

b n=517,

c n=515,

* P<0.0001.

Abbreviations: CGI-SCH, Clinical Global Impression of Schizophrenia; LOCF, last observation carried forward; MSQ, Medication Satisfaction Questionnaire; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Table 3 Improvement/worsening in PANSS total score, CGI-SCH overall severity score, and MSQ score at month 18 for baseline PANSS score <70 subgroup (intent-to-treat population)

	N (%)	Mean score
PANSS total score (N=328)
Improved	219 (66.8)	40.0
No change	11 (3.4)	47.9
Worsened	98 (29.9)	64.9
Overall CGI-SCH severity score (N=331)
Improved	176 (53.2)	1.7
No change	105 (31.7)	2.6
Worsened	50 (15.1)	4.0
MSQ score (N=330)
Improved	172 (52.0)	6.0
No change	79 (23.9)	4.9
Worsened	79 (23.9)	3.5

Abbreviations: CGI-SCH, Clinical Global Impression of Schizophrenia; MSQ, Medication Satisfaction Questionnaire; PANSS, Positive and Negative Syndrome Scale.

Figure 3 Hospitalizations during retrospective and prospective periods (mirror analyses population).

Notes: (A) Mean number of hospitalization days/person/year for total mirror analyses population. (B) Mean number of hospitalization days/person/year in patients with >1 year schizophrenia history. *P<0.0001 compared with retrospective period. (C) Mean number of hospitalization days/person/year for patients hospitalized within past 12 months. (D) Mean number of hospitalization days/person/year after excluding <1 year schizophrenia history patients. *P<0.0001.

Table 4 Treatment-emergent adverse events in at least 5% patients (safety population)

Most common TEAEs (>5% patients)	Paliperidone palmitate (N=521)
	n (%)
Total number of patients with TEAEs	429 (82.3)
Injection site pain	97 (18.6)
Insomnia	79 (15.2)
Akathisia	70 (13.4)
Headache	59 (11.3)
Abnormal weight gain	51 (9.8)
Upper respiratory tract infection	46 (8.8)
Dizziness	37 (7.1)
Psychotic disorder	42 (8.1)
Weight increased	39 (7.5)
Nausea	34 (6.5)
Tremor	33 (6.3)
Worsening of schizophrenia	33 (6.3)
Anxiety	29 (5.6)
Somnolence	27 (5.2)
Restlessness	26 (5.0)

Abbreviation: TEAEs, treatment-emergent adverse events.