10/17/2018 Programme of the 31st ECNP Congress - Barcelona 2018

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Programme of the 31st ECNP Congress -

Barcelona 2018
BACK TO MY SEARCH RESULTS
Presentation No: P.272

Session title: Poster presentation

Session type: Poster session

Stable schizophrenia patients switched to paliperidone

palmitate 3-monthly formulation in real life: functioning
and resource use
P. Garcia-Portilla (1), P.M. Llorca (2), G. Maina (3), V.P. Bozikas (4), H. Devrimci-Ozguven (5), S.W.
Kim (6), P. Bergmans (7), I. Usankova (8), P. Cherubin (9), K. Pungor (10)

(1)
University of Oviedo, Cibersam, Oviedo, Spain
(2)
CHRU Clermont- Ferrand, Pôle Psychiatrie, Clermont-Ferrand, France
(3)
Università degli Studi di Torino, SCDU Psichiatria- AOU San Luigi Gonzaga, Torino, Italy
(4)
Aristotle University of Thessaloniki, Department of Psychiatry- School of Medicine,
Thessaloniki, Greece
(5)
Ankara University, School of Medicine- Department of Psychiatry, Ankara, Turkey
(6)
Chonnam National University, Medical School, Gwangju, South-Korea
(7)
Janssen Cilag- Biostatistics & Programming, Biostatistics & Programming, Breda, The
Netherlands
(8)
Johnson & Johnson, Medical Affairs Organization, Moscow, Russia
(9)
Janssen Cilag, EMEA Medical Affairs, Issy-les-Moulineaux, France
(10)
Janssen Cilag, EMEA Medical Affairs, Dusseldorf, Germany

Paliperidone 3-monthly formulation (PP3M) has demonstrated favourable e cacy and safety
in clinically stable patients during randomized controlled clinical trials [1-3]. However, due to
the nature of these studies, only selected patient populations were included.

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10/17/2018 Programme of the 31st ECNP Congress - Barcelona 2018

REMISSIO was a prospective, single-arm, open-label, 52-week study conducted to assess the
effectiveness of PP3M in clinically stable schizophrenia patients within a naturalistic setting.
Eligible patients were aged 18-50 years with schizophrenia (DSM-5), adequately treated with
paliperidone palmitate 1-month formulation (PP1M) for ≥4 months (the last 2 doses of PP1M
being the same), and had a Positive and Negative Syndrome Scale (PANSS) total score <70.
Initial PP3M dose and subsequent dose changes (at clinician's discretion) were made
according to the product label [4]. The primary outcome was the number of patients
achieving symptomatic remission (SR) at the last observation carried forward (LOCF)
endpoint. Secondary outcomes included functioning, medication satisfaction and healthcare
resource use. The intent-to-treat (ITT) population comprised 305 patients from Europe, the
Middle East and Asia, who had received ≥1 dose of PP3M. Treatment response analyses
were performed on the e cacy ITT population (n=303). Endpoint analysis using LOCF was
performed, in addition to observed case analysis.

The patients had a mean (standard deviation; SD) age of 36.5 (8.0) years and 66% were male,
with a mean (SD) 11.5 (7.3) years since psychotic symptom onset, and 10.3 (7.2) years since
antipsychotic drug initiation. The primary endpoint of SR (a score of ≤3 on PANSS items P1,
P2, P3, N1, N4, N6, G5, and G9 maintained for ≥6 months) [5] at LOCF endpoint was met by
172 patients (56.8%).

At baseline mean (SD) Personal and Social Performance (PSP) score was 65.9 (14.0) with
38.4% of patients having a score >70. Mean LOCF endpoint PSP score was 66.9 (95%CI, 65.3,
68.5) with 39.8% having a score >70. All four PSP subdomains (scaled 1-6) showed a similar
effect with each a mean positive change of 1.45 (95%CI, 1.3, 1.6). In relevant subgroups,
comparable maintenance of LOCF PSP score was seen: mean (95%CI) PSP score of patients
with LOCF SR: 1.95 (95%CI, 0.5, 3.4), without LOCF SR: -0.14 (95%CI, -2.5, 2.2), with PP1M
duration >6 months: 1.23 (95%CI, -0.3, 2.8), with PP1M duration 4-6 months: 1.52 (95%CI,
-0.9, 4.0), switching from antipsychotic monotherapy: 1.24 (95%CI, -0.2, 2.7), or polytherapy:
0.08 (95%CI, -3.2, 3.4).

A total of 59.6% and 61.6% of patients were very/extremely satis ed with their medication,
respectively, at baseline and LOCF endpoint. The proportion of clinicians who were overall
very/extremely satis ed with medication increased from 67.2% at baseline to 75.4% at LOCF
endpoint. During the 12 months prior to baseline, 12.2% of patients had ≥1 psychiatric
hospitalization; this decreased to 2.6% during the data collection period. Emergency
department visits for psychiatric reasons were recorded for 3.6% and 1.0% of patients during
the 12 months prior to baseline and at LOCF endpoint, respectively.

In conclusion, routine clinical use of PP3M in clinically stable schizophrenia patients

maintained personal and social functioning scores; healthcare resource used decreased over
the data collection period.

References

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10/17/2018 Programme of the 31st ECNP Congress - Barcelona 2018

[1] Berwaerts J., Liu Y., Gopal S., Nuamah I., Xu H., Savitz A., Coppola D., Schotte A.,
Remmerie B., Maruta N., Hough D.W. 2015. E cacy and safety of the 3-month formulation of
paliperidone palmitate vs placebo for relapse prevention of schizophrenia. A randomized
clinical trial. JAMA Psychiatry 72, 830-839.

[2] Savitz A.J., Xu H., Gopal S., Nuamah I., Ravenstijn P., Janik A., Schotte A., Hough D.,
Fleischhacker W.W. 2016. E cacy and safety of paliperidone palmitate 3-month formulation
for patients with schizophrenia: A randomized, multicentre, double-blind, noninferiority study.
Int J Neuropsychopharmacol 19, 1-14.

[3] Savitz A.J., Xu H., Gopal S., Nuamah I., Hough D., Mathews M. 2017. Paliperidone
palmitate 3-month treatment results in symptomatic remission in patients with
schizophrenia: a randomized, multicentre, double-blind, and noninferiority study. Int Clin
Psychopharmacol 32, 329-336.

[4] TREVICTA prolonged release suspension for injection. Summary of Product

Characteristics.

[5] Andreasen N.C., Carpenter W.T. Jr., Kane J.M., Lasser R.A., Marder S.R., Weinberger D.R.
2005. Remission in schizophrenia: proposed criteria and rationale for consensus. Am J
Psychiatry 162,441-449.

Con ict of interest:

Disclosure statement: Bergmans, Paul - employee of Janssen stockholder of Johnson &
Johnson Cherubin, Pierre - employee of Janssen Pungor, Katalin - employee of Janssen
Usankova, Irina - employee of Janssen Garcia-Portilla, Paz - : Maria Paz Garcia-Portilla has
been a consultant to and/or has received honoraria/grants from Alianza Otsuka-Lundbeck,
Angellini, CIBERSAM, European Comission, Europena Medicines Agency, Instituto de Salud
Carlos III, Janssen-Cilag, Lilly, Lundbeck, Otsuka, P zer, Servier, Roche, and Rovi. Llorca,
Pierre Michel - Honorarium from Janssen, EISAI, Lundbeck, Otsuka, Bouchara-Recordatti for
conference, advisory board and expert consulting Maina, Giuseppe - No con icts of interest
to disclose Bozikas, Vasillis - No con icts of interest to disclose Özgüven, Halise - No
con icts of interest to disclose Sung-Wan, Kim - No con icts of interest to disclose

Topics:
Pharmacology - Intervention
Psychotic disorder

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