Switching from oral atypical antipsychotic monotherapy to paliperidone palmitate once-monthly in non-acute patients with schizophrenia: A prospective, open-label, interventional study.
Long-acting injectable antipsychotic therapies may offer benefits over oral antipsychotics in patients with schizophrenia.



This study aimed to explore the safety, tolerability, and treatment response of paliperidone palmitate once-monthly in non-acute but symptomatic adult patients switched from previously unsuccessful monotherapy with frequently used oral atypical antipsychotics.



This was a post hoc analysis of a prospective, interventional, single-arm, international, multicenter, open-label, 6-month study.



The patients (N = 472) were switched to paliperidone palmitate once-monthly (PP1M) from daily oral treatment with either aripiprazole (n = 46), olanzapine (n = 87), paliperidone extended-release (n = 104), quetiapine (n = 44), or risperidone (n = 191). In all groups, mean Positive and Negative Syndrome Scale total (p < 0.0001) and Clinical Global Impression-Severity scores improved significantly (p = 0.0004 to p < 0.0001). An improvement of ≥50 % in the Positive and Negative Syndrome Scale total score was observed in 21.7 % (aripiprazole), 29.9 % (olanzapine), 29.8 % (paliperidone extended-release), 27.3 % (quetiapine), and 37.2 % (risperidone) of patients. The patients showed significant improvements in the Personal and Social Performance score (aripiprazole p = 0.0409, all others p ≤ 0.0015); Mini International Classification of Functionality, Disability and Health Rating for Activity and Participation Disorders in Psychological Illnesses total scores (all p < 0.01); and Treatment Satisfaction Questionnaire for Medication Global Satisfaction score (olanzapine and risperidone p < 0.0001, quetiapine p = 0.0465, paliperidone extended-release p = 0.0571, aripiprazole p = NS). Paliperidone palmitate once-monthly was well tolerated, presenting no new safety signals.



These data illustrate that stable, non-acute but symptomatic patients on oral antipsychotic monotherapy may show clinically meaningful improvement of symptoms, functioning, and treatment satisfaction after direct transition to PP1M. The findings are limited by the naturalistic study design; thus, further studies are required to confirm the current findings.
Medical & Scientific Affairs, Janssen Cilag EMEA, Johnson & Johnson Platz 1, 41470, Neuss, Germany. aschrein@its.jnj.com.
Andreas
A
Schreiner
Psychiatric Ambulatory Clinic, Sheba Medical Center, Ramat Gan, Israel.
Asaf
A
Caspi
Biometrics and Reporting, Janssen Cilag Benelux, Tilburg, The Netherlands.
Paul
P
Bergmans
Medical Affairs, Janssen Cilag EMEA, Issy-les-Moulineaux, France.
Pierre
P
Cherubin
Global Clinical Operations EMEA MAO, Janssen Cilag, Barcarena, Portugal.
Sofia
S
Keim
Hospital CUF Infante Santo, Lisbon, Portugal.
Elsa
E
Lara
Ukrainian Research Institute of Social and Forensic Psychiatry and Drug Abuse, Ministry of Health of Ukraine, Kiev, Ukraine.
Irina
I
Pinchuk
Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich, Zurich, Switzerland.|Klinikum am Weissenhof, Weinsberg, Germany.
Daniel
D
Schuepbach
South London & Maudsley NHS Foundation Trust, Ladywell Unit, University Hospital Lewisham, London, UK.
Sajid
S
Suleman
Medical & Scientific Affairs, Janssen Cilag EMEA, Johnson & Johnson Platz 1, 41470, Neuss, Germany.
Ludger
L
Hargarter
D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D000068882:Paliperidone Palmitate / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011446:Prospective Studies; D018967:Risperidone / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000068180:Aripiprazole; D018967:Risperidone; D000077152:Olanzapine; D000068882:Paliperidone Palmitate
Functioning; Long-acting injectable antipsychotic therapy; Non-acute; Oral antipsychotic; Paliperidone palmitate; Schizophrenia; Switching; Treatment satisfaction