Tratamientos
Use of Paliperidone Palmitate in Acute Units: post-hoc analysis of the SHADOW study according to previous antipsychotic treatment

P.3.d.042
Use of Paliperidone Palmitate in Acute Units: post-hoc analysis
of the SHADOW study according to previous antipsychotic treatment
(1)

(2)

(2)

(3)

(3)

Manuel Serrano , Eduard Parellada , Miquel Bioque , Begoña Nebot , Berta Herrera , Marta García Dorado
(1)

(3)

(2)

Hospital Marítimo de Oza, A Coruña, Unitat d'Esquizofrènia Clínic, Hospital Clínic de Barcelona Centro de
(3)
Investigación Biomédica en Red en Salud Mental (CIBERSAM), Medical Affairs Department, Janssen

Introduction

Methods

The use of long-acting treatments (LATs) in acute units has been increasing recently
partly because of the availability of new second-generation LATs with rapid onset of
(1)
action . It is also important to increase knowledge on how these treatments behave
within a real world setting, in which a diverse patient population is found.

An observational, prospective 6-week-study was performed in acute units including adult patients with acute exacerbation of schizophrenia who started treatment
with PP during an admission (index admission) due to a relapse. Changes in Clinical
Global Inventory (CGI-SCH) and total score on the Personal and Social Performance
scale (PSP) were used to assess changes in illness severity and functionality, respectively. Data were collected from initiation of PP and for a period of 6 weeks (or
patient's discharge if earlier). Previous antipsychotic treatment before admission
was recorded.
A paired Student-t test was performed for assessing changes in CGI-SCH and PSP
between basal and endpoint visits. The Kruskal-Wallis test was used to assess association between changes in the main variables and previous treatment. The Spearman
correlation test was used to relate index hospitalization total length of stay to the
length of time since admission to initiation of PP. Statistically significant differences
were declared if p<0.05. No adjustment was made for multiplicity.

Aim of the study
The main purpose of this post-hoc analysis is to assess the changes in the severity of
the disease in patients with schizophrenia who require, according to standard clinical practice, treatment with Paliperidone Palmitate (PP) during admission into acute
[1,2]
units due to relapse (primary results have been previously presented ). This posthoc analysis has been performed according to the previous antipsychotic treatment these patients had at admission.

Discussion

Results
Two hundred and eighty patients were included in the analysis. Twenty-one % of
patients were discharged on PP-monotherapy.
A significant clinical and functional improvement (mean CGI-SCH, Figure 1, and PSP
scores, Figure 2) from baseline to endpoint was observed for the total population
(both p-values <0.0001). Additional post-hoc analysis was performed according to
the following antipsychotic (AP) treatments subgroups (n, %) taking into account
the antipsychotic treatment at admission: only oral treatments (137, 48.9%), AP treatment which includes a second generation long-acting treatment (51, 18.2%), no AP
treatment (77, 27.5%) and AP treatment that includes conventional depots (15, 5.4%)
(Figure 3).

7
6

*p<0.0001

*p<0.0001

Day 8 (±4 days)

Discharge or week 6

**
**
**
**

**

5
4
3
2
1
0
Day 1

Figure 1. Mean CGI-S Total Score
(*) p<0.0001

100

6
5,5

**
Mean CGI-S Total Score

PSP Total Score

80

27,5%

60

48,9%

40
5,4%

20

18,2%

5
4,5
4
3,5
3

0

**

2,5

Day 1

Discharge or week 6

Day 1

Oral treatments
Conventional depots

Figure 2. Mean PSP Total Score
(** p<0.0001 vs basal point)

Second generation long-acting treatment
No AP treatment

**

**

**

**

5,5

100
100

40
30

Proportion of patients (%)

Mean CGI-S Total Score

50

5
4,5

**
**

4

**

3,5

**
**

20
3

10

Oral treatments (N=137)
Conventional depots (N=15)

Figure 5. Mean PSP Total Score
(** p<0.0001 vs basal point)

Discharge or week 6

00

Second generation long-acting treatment (N=51)
No AP treatment (N=77)

Day 1

Risperidone (N=32)

Day 8 (±4 days)

Olanzapine (N=38)

72,4%
72,4

Conclusions

66,4%
66,4

2,1%
2,1

Day 1

Discharge or week 6

Mild difficulties (PSP>70)
Intensive support is needed (PSP<31)

Other treatment (N=67)

Figure 6. Mean CGI-S Total Score: patients with Risperidone, Olanzapine and
Others treatment at endpoint (**p<0.0001 vs basal point)

Statistically significant improvements in CGI-SCH (Figure 4) and PSP total scores
(Figure 5) were found in all subgroups regardless of previous treatment (p<0.0001).
Also, a second subanalysis was performed according to the daily oral antipsychotic
treatment upon admission (Figure 6). No differences were found between groups
(Kruskal-Wallis test, p-value).
This Patient-functioning was consistent with the distribution of frequencies in each
category (Figure 7).
A significant correlation was found between time since admission to PP initiation
and the total length of stay (Spearman correlation coefficient 0.5125; p <0.0001)
(Figure 8).

30,7%
30,7

60
60
40
40

2,5
2,5%

25,1%
25,1

Discharge or week 6
Varying degrees of disability (PSP 31-70)
Missing

Figure 7. Frequency distribution of PSP total score

These results support the effectiveness of PP in an acute setting in a
population of daily clinical practice
after initiation of PP from different
antipsychotic treatments.

100
90
80
Mean Length of stay (days)

Day 1

80
80

0,7
0,7%

20
20

**

2,5

0

Second generation long-acting treatment (N=51)
No AP treatment (N=77)

120
120

70
60

Discharge or week 6

Figure 4. Mean CGI-S Total Score per antispychotic treatment at admission
(**p<0.0001 vs basal point)

6

80

Day 8 (±4 days)

Oral treatments (N=137)
Conventional depots (N=15)

Figure 3. % Patients with antipsychotic treatment at admission

90

PSP Total Score (SD)

**
**

The use of long-acting atypical antipsychotics (LATs) are becoming more
widespread due to the availability of
new options and the reduction of bias
(3)
and some false beliefs regarding
LATs. Also, it is important to display of
real world evidence data that confirms
results from interventional trials in a
naturalistic population and setting.
The population of this observational
study, performed with minimal lowrestrictive inclusion criteria is representative of patients seen in daily clin(2)
ical practice within the acute units .
This post-hoc analysis is consistent
with results from other trials efficacy,
safety, and impact of PP on hospitali(4)
zations studied .
The data related to the pattern of use
of PP show that the use of PP improves
symptoms and functionality of
patients regardless of previous
antipsychotic treatment.

(*)There are two patients (values) not included in this figure with
a length of stay of 125 and 190 days and, a time since admission to
PP initiation of 116 and 147 days respectively

Bibliography

70
60
50
40
30
20
10
0
0-5

6-10

11-15 16-20 21-25 26-30 31-35 36-40
Time since admission to PP initiation (days)

41-45

Figure 8. Correlation between time since admission to PP initiation,
and lenght of stay*

Limitations of this study (due to the study design): 1) antipsychotic polytherapy was
allowed as a reflection of clinical practice, 2) long acting treatments may have beneficial
clinical outcomes for first episode patients, but, due to the fact that a clear schizophrenia
diagnosis must be established, these patients were ruled out.

+ 46

1. Gopal S. et al. Innov Clin Neurosci.
2011;8(8):26-33.
2. Hamann J. et al. European Neuropsychopharmacology. 2014; 24, 1506-10
3. Parellada E. et al. 27 ECNP Congress, 18-21
October 2014, Berlin, Germany.
(P.3.d.049).
4. Zhang F. et al. Neuropsychiatric Disease
and Treatment 2015:11 657-668.

[1] 24th European Congress of Psychiatry (EPA 2016), Madrid, Spain, 12-15 March 2016:
EPA16-0795.
[2] 27th European Congress of Neuropsychopharmacology (ECNP 2014), Berlin,
Germany, 18-21 October 2014: P.3.d.049.

Poster presented at the 29th ECNP Congress of Applied and Translational Neuroscience (ECNP 2016), Vienna, Austria, 17-20 september 2016 (Poster number: P.3.d.042)
The editorial support of this poster and the SHADOW study were sponsored by funding from Janssen-Cilag, S.A.
Manuel Serrano has been a consultant for, received grant/research support and honoraria from, and been on the speakers/advisory board of Otsuka, Janssen-Cilag, Lundbeck and GlaxoSmithKline.



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