TY - JOUR
T1 - Intramuscular long-acting paliperidone palmitate in acute patients with schizophrenia unsuccessfully treated with oral antipsychotics
AU - Hargarter, Ludger
AU - Cherubin, Pierre
AU - Bergmans, Paul
AU - Keim, Sofia
AU - Rancans, Elmars
AU - Bez, Yasin
AU - Parellada, Eduard
AU - Carpiniello, Bernardo
AU - Vidailhet, Pierre
AU - Schreiner, Andreas
N1 - Funding Information:
Drs. Hargarter, Bergmans and Schreiner, and Ms. Keim are full-time employees of Janssen Cilag and shareholders of Johnson and Johnson. Dr. Cherubin is a full-time employee of Janssen Cilag. Dr. Rancans has received research grants from AstraZeneca, GlaxoSmithKline, Janssen Cilag and Lundbeck. In addition, Dr. Rancans received speaker honoraria from and is a member of advisory panels for AstraZeneca, GlaxoSmithKline, Janssen Cilag, Lundbeck, Sanofi Synthélabo and Servier. Dr. Bez has received research funds from Lundbeck, Sanofi-Aventis, AstraZeneca, Pfizer and Janssen Cilag. In addition, Dr. Bez has received speaker honoraria from Nobel, Bilim and Janssen Cilag, travel grants from Sanovel, Sanofi-Aventis, Janssen Cilag, Bilim and Janssen Cilag and is a member of advisory panels for Nobel and Janssen Cilag. Dr. Carpiniello has received research funds from AstraZeneca and Lundbeck. In addition, Dr. Carpiniello has received speaker honoraria from Lundbeck, Pfizer, Jannsen Cilag, AstraZeneca, Otsuka, ACRAF Angelini and Eli-Lilly, and is a member of advisory panels for Lundbeck and Otsuka. Dr. Parellada has received honoraria and/or research grants from the Fondo de Investigación Sanitaria (registered number PI080055) of the Spanish Ministry of Science and Innovation, Fundació la Marató de TV3 of Catalonia, Janssen Cilag and GlaxoSmithKline. Dr. Vidailhet has received speaker honoraria from Janssen, Otsuka, Lundbeck, Bristol Myers Squibb and Roche, travel grants from Janssen, Lundbeck and Otsuka, and is a member of advisory panels for Janssen, Roche and Otsuka.
Funding Information:
This study was sponsored by Janssen Cilag International NV . The authors thank apothecom scopemedical ltd, Sevenoaks, UK, for writing assistance, funded by Janssen Pharmaceutica NV.
Publisher Copyright:
© 2014.
PY - 2015/4/3
Y1 - 2015/4/3
N2 - In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150 mg eq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≤ 30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events (TEAEs). Overall, 212 patients received PP at least once after switching from oral antipsychotics, primarily due to lack of efficacy (45.8%). Significant improvements from BL in mean (SD) PANSS total score were observed from Day 8 onwards (BL to LOCF EP: -. 31.0 [29.0]; p. < 0.0001). At endpoint, two-thirds (66.7%) and 43.5% of patients achieved a ≤ 30% and ≤ 50% improvement in mean PANSS total score, respectively. PP was associated with significant improvements across secondary measures of symptom severity, subjective well-being, medication satisfaction, illness-related disorders of activity and participation, and patient functioning (p. < 0.0001; BL to LOCF EP). PP was generally well tolerated, with significant reductions in ESRS total score (p < 0.0001) and mainly mild-to-moderate TEAEs. TEAEs reported in ≤ 5% of patients were injection-site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache and anxiety (both 6.1%). The PALMFlexS study findings provide valuable pragmatic clinical data on PP treatment in patients with acute schizophrenia previously unsuccessfully treated with oral antipsychotics.
AB - In this prospective multicentre, open-label, 6-month study (Paliperidone Palmitate Flexible Dosing in Schizophrenia [PALMFlexS]), tolerability, safety and treatment response with paliperidone palmitate (PP) were explored in patients with acute symptoms of schizophrenia following switching from previously unsuccessful treatment with oral antipsychotics. This pragmatic study was conducted in a large, more representative sample of the general schizophrenia population compared to randomized controlled pivotal trials, to specifically mimic real-world clinical situations. After initiation on Day 1 and Day 8, patients received PP once monthly at flexible doses (50-150 mg eq.) intramuscularly. The primary efficacy outcome was defined as the percentage of patients achieving ≤ 30% improvement in PANSS total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events (TEAEs). Overall, 212 patients received PP at least once after switching from oral antipsychotics, primarily due to lack of efficacy (45.8%). Significant improvements from BL in mean (SD) PANSS total score were observed from Day 8 onwards (BL to LOCF EP: -. 31.0 [29.0]; p. < 0.0001). At endpoint, two-thirds (66.7%) and 43.5% of patients achieved a ≤ 30% and ≤ 50% improvement in mean PANSS total score, respectively. PP was associated with significant improvements across secondary measures of symptom severity, subjective well-being, medication satisfaction, illness-related disorders of activity and participation, and patient functioning (p. < 0.0001; BL to LOCF EP). PP was generally well tolerated, with significant reductions in ESRS total score (p < 0.0001) and mainly mild-to-moderate TEAEs. TEAEs reported in ≤ 5% of patients were injection-site pain (13.7%), insomnia (10.8%), psychotic disorder (10.4%), headache and anxiety (both 6.1%). The PALMFlexS study findings provide valuable pragmatic clinical data on PP treatment in patients with acute schizophrenia previously unsuccessfully treated with oral antipsychotics.
KW - Acute
KW - Efficacy
KW - Long-acting
KW - Paliperidone palmitate
KW - Schizophrenia
KW - Switching
UR - http://www.scopus.com/inward/record.url?scp=84918791715&partnerID=8YFLogxK
U2 - 10.1016/j.pnpbp.2014.11.006
DO - 10.1016/j.pnpbp.2014.11.006
M3 - Article
C2 - 25448776
AN - SCOPUS:84918791715
SN - 0278-5846
VL - 58
SP - 1
EP - 7
JO - Progress in Neuro-Psychopharmacology and Biological Psychiatry
JF - Progress in Neuro-Psychopharmacology and Biological Psychiatry
ER -