Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study.
OBJECTIVE
The Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study compared the effects of once-monthly paliperidone palmitate with daily oral antipsychotics on treatment failure in adults with schizophrenia.


METHODS
The PRIDE study is a 15-month, randomized, multicenter study (May 5, 2010, to December 9, 2013) of adult subjects with a DSM-IV diagnosis of schizophrenia and a history of incarceration. Subjects were randomly assigned to once-monthly paliperidone palmitate injections or daily oral antipsychotics (randomly assigned from 7 acceptable, prespecified oral antipsychotics) for 15 months. The primary end point was time to first treatment failure, defined as arrest/incarceration; psychiatric hospitalization; suicide; treatment discontinuation or supplementation due to inadequate efficacy, safety, or tolerability; or increased psychiatric services to prevent hospitalization. Time to first treatment failure was determined by a blinded event-monitoring board and analyzed with the Kaplan-Meier method.


RESULTS
In this study, 450 patients were randomly assigned, and 444 were included in the intent-to-treat population. Paliperidone palmitate was associated with significant delay in time to first treatment failure versus oral antipsychotics (hazard ratio, 1.43; 95% CI, 1.09-1.88; log rank P = .011). Observed treatment failure rates over 15 months were 39.8% and 53.7%, respectively. Arrest/incarceration and psychiatric hospitalization were the most common reasons for treatment failure in the paliperidone palmitate and oral antipsychotic groups (21.2% vs 29.4% and 8.0% vs 11.9%, respectively). The 5 most common treatment-emergent adverse events for the paliperidone palmitate treatment group were injection site pain (18.6% of subjects), insomnia (16.8%), weight increased (11.9%), akathisia (11.1%), and anxiety (10.6%).


CONCLUSIONS
In a trial designed to reflect real-world management of schizophrenia, once-monthly paliperidone palmitate demonstrated superiority compared to oral antipsychotics in delaying time to treatment failure.


BACKGROUND
Clinicaltrials.gov Identifier: NCT01157351.
Therapeutic Team Leader: Psychiatry, Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Rd-A32404, Titusville, NJ 08560 lalphs@its.jnj.com.
Larry
L
Alphs
Carmela
C
Benson
Kimberly
K
Cheshire-Kinney
Jean-Pierre
JP
Lindenmayer
Lian
L
Mao
Stephen C
SC
Rodriguez
H Lynn
HL
Starr
D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D057237:Criminals; D005260:Female; D006760:Hospitalization; D006801:Humans; D007273:Injections, Intramuscular; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D010168:Palmitates / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D012559:Schizophrenia / Q000188:drug therapy*; D016037:Single-Blind Method; D017211:Treatment Failure; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D007555:Isoxazoles; D010168:Palmitates; D000068882:Paliperidone Palmitate