TY - JOUR
T1 - A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents
AU - Schreiner, Andreas
AU - Bergmans, Paul
AU - Cherubin, Pierre
AU - Keim, Sofia
AU - Rancans, Elmars
AU - Bez, Yasin
AU - Parellada, Eduard
AU - Carpiniello, Bernardo
AU - Vidailhet, Pierre
AU - Hargarter, Ludger
N1 - Funding Information:
Dr. Schreiner, Mr. Bergmans and Ms. Keim are full-time employees of Janssen-Cilag and shareholders of Johnson & Johnson. Dr. Rancans participated in advisory boards for and cooperated in clinical trials with AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Lundbeck, M’s Science Corporation, Otsuka, Pfizer and Servier, has received speaker’s fees from AstraZeneca, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Pfizer, Sanofi Synthlabo and Servier and was Principal Investigator for one site in the PALMFlexS study. Dr. Bez has received speaker honoraria from Nobel, Bilim and Janssen-Cilag, travel grants from Sanovel, Sanofi-Aventis, Janssen-Cilag and Bilim, and is member of advisory panels for Nobel and Janssen-Cilag. 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. Carpiniello has received financial support as a participant to scientific boards or as a speaker in congresses or courses and grants for research from AstraZeneca, Janssen, Pfizer, Otsuka, Lundbeck, Angelini and Eli Lilly. Dr. Vidailhet has received investigation fees for the PALMFlexS study, speaker's honoraria and is member of advisory panels for Janssen, Lundbeck, Bristol-Myers Squibb, Eli Lilly, Roche, and research grants from the French Health Ministry, the French Education and Research Ministry and the University Hospital of Strasbourg, France. Dr. Cherubin is a full-time employee of Janssen-Cilag. Ludger Hargarter is a full-time employee and a member of Medical Affairs EMEA at Janssen-Cilag GmbH, Neuss, Germany.
Publisher Copyright:
© 2014 The Authors.
PY - 2014/11/10
Y1 - 2014/11/10
N2 - Implications The PALMFlexS study is a pragmatic interventional study compared with randomized controlled trials, conducted in a large, more representative sample of patients with schizophrenia, and designed specifically to mimic real-world clinical situations. The findings support the results from randomized controlled studies. The findings support results from randomized controlled studies. They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients. Clinical trials.gov number: NCT01281527.Purpose The goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study.Methods This was an interventional, single-arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. Patients were categorized according to reasons for switching. In patients switching because of lack of efficacy or for other reasons, primary efficacy outcomes were the proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to last-observation-carried-forward end point) and maintained efficacy (defined as noninferiority in the change in PANSS total score at end point versus baseline [Schuirmann's test]), respectively.Findings A total of 593 patients (intention-to-treat population) were enrolled: 63.1% were male; their mean (SD) age was 38.4 (11.8) years; and 78.6% had paranoid schizophrenia. The main reasons for transition to PP were patient's wish (n = 259 [43.7%]), lack of efficacy (n = 144 [24.3%]), lack of compliance (n = 138 [23.3%]), and lack of tolerability (n = 52 [8.8%]) with the previous oral antipsychotic medication. The recommended PP initiation regimen (150 milligram equivalents [mg eq] day 1 and 100 mg eq day 8) was administered in 93.9% of patients. Mean PANSS total score decreased from 71.5 (14.6) at baseline to 59.7 (18.1) at end point (mean change, -11.7 [15.9]; 95% CI, -13.0 to -10.5; P < 0.0001). Sixty-four percent of patients showed an improvement of ≥20% in PANSS total score, and the percentage of patients rated mildly ill or less in Clinical Global Impression-Severity increased from 31.8% to 63.2%. Mean personal and social performance total score (SD) increased (ie, improved) significantly for all patients from baseline to end point (58.1 [13.4] to 66.1 [15.7]; P < 0.0001).
AB - Implications The PALMFlexS study is a pragmatic interventional study compared with randomized controlled trials, conducted in a large, more representative sample of patients with schizophrenia, and designed specifically to mimic real-world clinical situations. The findings support the results from randomized controlled studies. The findings support results from randomized controlled studies. They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients. Clinical trials.gov number: NCT01281527.Purpose The goal of this study was to explore the tolerability, safety, and treatment response of flexible doses of once-monthly paliperidone palmitate (PP) in the subset of nonacute but symptomatic adult patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents in the PALMFlexS (Paliperidone Palmitate Flexible Dosing in Schizophrenia) study.Methods This was an interventional, single-arm, international, multicenter, unblinded, 6-month study performed in patients with schizophrenia. Patients were categorized according to reasons for switching. In patients switching because of lack of efficacy or for other reasons, primary efficacy outcomes were the proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to last-observation-carried-forward end point) and maintained efficacy (defined as noninferiority in the change in PANSS total score at end point versus baseline [Schuirmann's test]), respectively.Findings A total of 593 patients (intention-to-treat population) were enrolled: 63.1% were male; their mean (SD) age was 38.4 (11.8) years; and 78.6% had paranoid schizophrenia. The main reasons for transition to PP were patient's wish (n = 259 [43.7%]), lack of efficacy (n = 144 [24.3%]), lack of compliance (n = 138 [23.3%]), and lack of tolerability (n = 52 [8.8%]) with the previous oral antipsychotic medication. The recommended PP initiation regimen (150 milligram equivalents [mg eq] day 1 and 100 mg eq day 8) was administered in 93.9% of patients. Mean PANSS total score decreased from 71.5 (14.6) at baseline to 59.7 (18.1) at end point (mean change, -11.7 [15.9]; 95% CI, -13.0 to -10.5; P < 0.0001). Sixty-four percent of patients showed an improvement of ≥20% in PANSS total score, and the percentage of patients rated mildly ill or less in Clinical Global Impression-Severity increased from 31.8% to 63.2%. Mean personal and social performance total score (SD) increased (ie, improved) significantly for all patients from baseline to end point (58.1 [13.4] to 66.1 [15.7]; P < 0.0001).
KW - long-acting antipsychotic
KW - nonacute
KW - paliperidone palmitate
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=84908297790&partnerID=8YFLogxK
U2 - 10.1016/j.clinthera.2014.08.014
DO - 10.1016/j.clinthera.2014.08.014
M3 - Article
C2 - 25444566
AN - SCOPUS:84908297790
SN - 0149-2918
VL - 36
SP - 1372-1388.e1
JO - Clinical Therapeutics
JF - Clinical Therapeutics
IS - 10
ER -