title: Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics.
abstract: PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (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. Significant reductions in mean PANSS total score were observed for all groups (-7.5 to -10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP.
authors.affiliation: EMEA Medical Affairs, Janssen Cilag GmbH, Neuss, Germany aschrein@its.jnj.com.
authors.forename: A
authors.initials: A
authors.lastname: Schreiner
authors.affiliation: Biometrics & Reporting, Janssen Cilag Benelux, Tilburg, the Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Bergmans
authors.affiliation: EMEA Medical Affairs, Janssen Cilag, Issy-les-Moulineaux, France.
authors.forename: P
authors.initials: P
authors.lastname: Cherubin
authors.affiliation: Global Clinical Operations EMEA Medical Affairs, Janssen Cilag, Barcarena, Portugal.
authors.forename: S
authors.initials: S
authors.lastname: Keim
authors.affiliation: CHRU Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: P-M
authors.initials: PM
authors.lastname: Llorca
authors.affiliation: Gazi University Medical Faculty, Ankara, Turkey.
authors.forename: B
authors.initials: B
authors.lastname: Cosar
authors.affiliation: UOPI of Psychiatry, AOU Policlinico Vittorio Emanuele, Catania, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Petralia
authors.affiliation: UOSM Distretto D, Pontecagnano-Faiano (Sa), Italy.
authors.forename: G
authors.initials: G
authors.lastname: Corrivetti
authors.affiliation: EMEA Medical Affairs, Janssen Cilag GmbH, Neuss, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Hargarter
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D000068882:Paliperidone Palmitate / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D011446:Prospective Studies; D018967:Risperidone / Q000008:administration & dosage / Q000494:pharmacology; D012559:Schizophrenia / Q000188:drug therapy*; D012720:Severity of Illness Index
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D018967:Risperidone; D000068882:Paliperidone Palmitate
keywords: Non-acute; injectable antipsychotic; paliperidone palmitate; schizophrenia; switching