title: Once-monthly paliperidone palmitate in recently diagnosed and chronic non-acute patients with schizophrenia.
abstract: OBJECTIVE
  To explore the treatment response, tolerability and safety of once-monthly paliperidone palmitate (PP1M) in non-acute patients switched from oral antipsychotics, stratified by time since diagnosis as recently diagnosed (≤3 years) or chronic patients (>3 years).
  
  
  METHODS
  Post hoc analysis of a prospective, interventional, single-arm, multicentre, open-label, 6-month study performed in 233 recently diagnosed and 360 chronic patients.
  
  
  METHODS
  The proportion achieving treatment response (defined as ≥20% improvement in Positive and Negative Syndrome Scale [PANSS] total score from baseline to endpoint) and maintained efficacy (defined as non-inferiority in the change in PANSS total score at endpoint [Schuirmann's test]).
  
  
  RESULTS
  71.4% of recently diagnosed and 59.2% of chronic patients showed a ≥20% decrease in PANSS total score (p = 0.0028 between groups). Changes in PANSS Marder factors, PANSS subscales, and the proportion of patients with a Personal and Social Performance scale (PSP) total score of 71-100 were significantly greater in recently diagnosed compared with chronic patients. PP1M was well tolerated, presenting no unexpected safety findings.
  
  
  CONCLUSIONS
  These data show that recently diagnosed patients treated with PP1M had a significantly higher treatment response and improved functioning, as assessed by the PSP total score, than chronic patients.
authors.affiliation: a Medical & Scientific Affairs , Janssen Cilag EMEA , Neuss , Germany.
authors.forename: L
authors.initials: L
authors.lastname: Hargarter
authors.affiliation: b Biometrics & Reporting , Janssen Cilag Benelux , Tilburg , The Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Bergmans
authors.affiliation: c Medical Affairs , Janssen Cilag EMEA , Issy-les-Moulineaux , France.
authors.forename: P
authors.initials: P
authors.lastname: Cherubin
authors.affiliation: d Global Clinical Operations EMEA MAO, Janssen Cilag , Barcarena , Portugal.
authors.forename: S
authors.initials: S
authors.lastname: Keim
authors.affiliation: e Department of Psychiatry , General Hospital , Bolzano , Italy.
authors.forename: A
authors.initials: A
authors.lastname: Conca
authors.affiliation: f Acute Inpatient Unit , Parc Sanitari Sant Joan de Déu , Barcelona , Spain and redIAPP, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Serrano-Blanco
authors.affiliation: g Department of Psychiatry and Psychotherapy , Semmelweis University , Budapest , Hungary.
authors.forename: I
authors.initials: I
authors.lastname: Bitter
authors.affiliation: h Department of Psychiatric , General Hospital of Arta , Arta , Greece.
authors.forename: N
authors.initials: N
authors.lastname: Bilanakis
authors.affiliation: a Medical & Scientific Affairs , Janssen Cilag EMEA , Neuss , Germany.
authors.forename: A
authors.initials: A
authors.lastname: Schreiner
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D000068882:Paliperidone Palmitate / Q000627:therapeutic use*; D011446:Prospective Studies; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D000068882:Paliperidone Palmitate
keywords: LAI; Long-acting injectable antipsychotic; paliperidone palmitate; schizophrenia; treatment response