Andreas Schreiner1, Kaire Aadamsoo2, A Carlo Altamura3, Manuel Franco4, Philip Gorwood5, Nikolaj G Neznanov6, Juan Schronen7, Alp Ucok8, Mathias Zink9, Adam Janik10, Pierre Cherubin11, Marjolein Lahaye12, Ludger Hargarter13. 1. Medical Affairs, Janssen Cilag EMEA, Neuss, Germany. Electronic address: aschrein@its.jnj.com. 2. North Estonia Medical Centre Foundation, Tallinn, Estonia. 3. Department of Psychiatry, University of Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. 4. Psychiatric Department, Zamora Hospital, Zamora, Spain. 5. Hôpital Sainte-Anne, Paris Descartes University (INSERM U894), France. 6. St Petersburg V.M. Bekhterev Psychoneurological Research Institute, St Petersburg, Russia. 7. Welgemoed Medical Centre, Cape Town, South Africa. 8. Istanbul Medical Faculty, Istanbul, Turkey. 9. Central Institute of Mental Health, Department of Psychiatry and Psychotherapy, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 10. Global Clinical Operations, Janssen-Cilag, Warsaw, Poland. 11. Medical Affairs, Janssen Cilag EMEA, Issy-les-Moulineaux, France. 12. Biostatistics, Janssen Cilag Benelux, Tilburg, The Netherlands. 13. Medical Affairs, Janssen Cilag EMEA, Neuss, Germany.
Abstract
OBJECTIVE:Relapse and acute exacerbation are common in schizophrenia and may impact treatment response and outcome. Evidence is conflicting in respect to superiority of long-acting injectable antipsychotic therapies versus oral antipsychotics in relapse prevention. This randomized controlled study assessed the efficacy of paliperidone palmitate versus oral antipsychotics for relapse prevention. METHOD: Eligible patients with a recent diagnosis of schizophrenia (within 1-5 years) were randomized 1:1 to paliperidone palmitate (n=376) or oral antipsychotic monotherapy (n=388) and entered a 2-week initial acute oral treatment phase. Patients who met predefined response criteria were eligible to enter the 24-month rater-blinded core treatment phase. Patients were evaluated for relapse, symptoms, functioning, quality of life, treatment satisfaction, and tolerability. RESULTS: In the core treatment phase, time to relapse was significantly longer in the paliperidone palmitate (n=352) compared with the oral antipsychotics arm (n=363): 85% of patients were relapse-free at 469 versus 249 days (P=0.019). Significantly fewer patients receiving paliperidone palmitate met the relapse criteria (52 [14.8%] versus 76 [20.9%, oral antipsychotics]; P=0.032), representing a 29.4% relative risk reduction. For paliperidone palmitate, a significantly greater improvement in Positive and Negative Syndrome Scale total score on Day 8 (P=0.021) and a trend at endpoint (P=0.075) were observed. Functioning improvements were comparable between treatment arms. No new safety signals were identified. CONCLUSION: The observed time to relapse superiority of paliperidone palmitate over oral antipsychotics provides further evidence for the value of long-acting injectable antipsychotic therapies in the treatment of schizophrenia, including during the early stages of illness.
RCT Entities:
OBJECTIVE: Relapse and acute exacerbation are common in schizophrenia and may impact treatment response and outcome. Evidence is conflicting in respect to superiority of long-acting injectable antipsychotic therapies versus oral antipsychotics in relapse prevention. This randomized controlled study assessed the efficacy of paliperidone palmitate versus oral antipsychotics for relapse prevention. METHOD: Eligible patients with a recent diagnosis of schizophrenia (within 1-5 years) were randomized 1:1 to paliperidone palmitate (n=376) or oral antipsychotic monotherapy (n=388) and entered a 2-week initial acute oral treatment phase. Patients who met predefined response criteria were eligible to enter the 24-month rater-blinded core treatment phase. Patients were evaluated for relapse, symptoms, functioning, quality of life, treatment satisfaction, and tolerability. RESULTS: In the core treatment phase, time to relapse was significantly longer in the paliperidone palmitate (n=352) compared with the oral antipsychotics arm (n=363): 85% of patients were relapse-free at 469 versus 249 days (P=0.019). Significantly fewer patients receiving paliperidone palmitate met the relapse criteria (52 [14.8%] versus 76 [20.9%, oral antipsychotics]; P=0.032), representing a 29.4% relative risk reduction. For paliperidone palmitate, a significantly greater improvement in Positive and Negative Syndrome Scale total score on Day 8 (P=0.021) and a trend at endpoint (P=0.075) were observed. Functioning improvements were comparable between treatment arms. No new safety signals were identified. CONCLUSION: The observed time to relapse superiority of paliperidone palmitate over oral antipsychotics provides further evidence for the value of long-acting injectable antipsychotic therapies in the treatment of schizophrenia, including during the early stages of illness.
Authors: Taishiro Kishimoto; Katsuhiko Hagi; Masahiro Nitta; Stefan Leucht; Mark Olfson; John M Kane; Christoph U Correll Journal: Schizophr Bull Date: 2018-04-06 Impact factor: 9.306
Authors: Luis Gutiérrez-Rojas; Sergio Sánchez-Alonso; Marta García Dorado; Paola M López Rengel Journal: CNS Drugs Date: 2022-04-23 Impact factor: 6.497
Authors: Lulu Lian; David D Kim; Ric M Procyshyn; Diana Cázares; William G Honer; Alasdair M Barr Journal: PLoS One Date: 2022-04-29 Impact factor: 3.240