Injectable paliperidone palmitate reduces incarcerations in schizophrenia

BERLIN – Once-monthly intramuscular paliperidone palmitate significantly delayed the unwelcome real world consequences of schizophrenia – including contact with the criminal justice system as well as psychiatric hospitalization – compared with oral antipsychotics, in the randomized PRIDE study.

PRIDE, or Paliperidone Palmitate Research in Demonstrating Effectiveness, deliberately enrolled the sort of real world patients with schizophrenia who are familiar to every clinician and jail warden but normally excluded from participation in clinical trials, including patients with a history of arrest and incarceration, and comorbid substance abuse.

Indeed, release from incarceration within the past 90 days was a prerequisite for eligibility for the PRIDE study, Dr. H. Lynn Starr explained at the annual congress of the European College of Neuropsychopharmacology.

Meanwhile, Janssen announced Nov. 13 that the Food and Drug Administration has approved the supplemental new drug applications for the long-acting drug for treating schizoaffective disorder.

PRIDE was a prospective, open-label, multicenter single-blind study in which 450 U.S. schizophrenia patients were randomized to treatment with once-monthly injectable paliperidone palmitate (Invega Sustenna) or daily oral antipsychotics for up to 15 months. Willingness to accept the long-acting injectable medication was a precondition for eligibility. Prior to randomization, patients sat down individually with a clinician, reviewed seven widely prescribed oral antipsychotics available in this study, and eliminated up to six of them from further consideration. They were then randomly assigned to flexibly dosed therapy with either an oral antipsychotic agent or injectable paliperidone palmitate.

The primary study endpoint was time to treatment failure, broadly defined in this study as a composite of arrest or incarceration; psychiatric hospitalization; suicide; dropout because of insufficient efficacy; discontinuation because of safety or tolerability issues; and the need for treatment supplementation with an additional antipsychotic because of inadequate efficacy, suicide risk, or increased use of psychiatric services in order to prevent imminent psychiatric hospitalization.

Median time to treatment failure was 226 days in the oral antipsychotic group and nearly twice as long at 416 days in the injectable paliperidone palmitate group. The treatment failure rate was 39.8% with paliperidone palmitate, compared with 53.7% with oral antipsychotics. This translated to a 43% greater risk of treatment failure in the oral therapy group, according to Dr. Starr of Janssen Pharmaceuticals in Titusville, N.J.

A prespecified key secondary endpoint was time to first psychiatric hospitalization or arrest/incarceration, as these outcomes are associated with considerable public health impact. The risk of either event proved to be 43% higher in the oral antipsychotic group. Arrest/incarceration and psychiatric hospitalization turned out to be the two most frequently occurring elements of the primary composite endpoint. Arrest/incarceration occurred in 21.2% of the paliperidone group, compared with 29.4% on oral antipsychotics. Eight percent of patients on long-term injectable therapy underwent psychiatric hospitalization, as did 11.9% on oral antipsychotics.

Patients on oral antipsychotic therapy not only experienced arrest/incarceration or psychiatric hospitalization sooner, they also had a significantly greater cumulative number of such events during follow-up.

The study drug was discontinued because of safety or tolerability issues in 6.6% of the paliperidone palmitate group and 3.7% on an oral antipsychotic. Erectile dysfunction was reported by 8.8% of patients on long-acting therapy but none on oral agents. Among women, amenorrhea occurred in 15.2% on paliperidone palmitate, vs. 3.6% on oral antipsychotics.

Thirty-two percent of patients on paliperidone palmitate had at least a 7% weight gain, as did 14% of the oral antipsychotic group.

In the oral antipsychotic group, 22% of patients were on paliperidone; 17%, on risperidone; 16.5%, on olanzapine; 15.1%, on aripiprazole; 13.3%, on quetiapine; 9.2%, on perphenazine; and 6.9%, on haloperidol.

The PRIDE study was funded by Janssen Scientific Affairs, where Dr. Starr serves as director of clinical development.

[email protected]

BERLIN – Once-monthly intramuscular paliperidone palmitate significantly delayed the unwelcome real world consequences of schizophrenia – including contact with the criminal justice system as well as psychiatric hospitalization – compared with oral antipsychotics, in the randomized PRIDE study.

PRIDE, or Paliperidone Palmitate Research in Demonstrating Effectiveness, deliberately enrolled the sort of real world patients with schizophrenia who are familiar to every clinician and jail warden but normally excluded from participation in clinical trials, including patients with a history of arrest and incarceration, and comorbid substance abuse.

Indeed, release from incarceration within the past 90 days was a prerequisite for eligibility for the PRIDE study, Dr. H. Lynn Starr explained at the annual congress of the European College of Neuropsychopharmacology.

Meanwhile, Janssen announced Nov. 13 that the Food and Drug Administration has approved the supplemental new drug applications for the long-acting drug for treating schizoaffective disorder.

PRIDE was a prospective, open-label, multicenter single-blind study in which 450 U.S. schizophrenia patients were randomized to treatment with once-monthly injectable paliperidone palmitate (Invega Sustenna) or daily oral antipsychotics for up to 15 months. Willingness to accept the long-acting injectable medication was a precondition for eligibility. Prior to randomization, patients sat down individually with a clinician, reviewed seven widely prescribed oral antipsychotics available in this study, and eliminated up to six of them from further consideration. They were then randomly assigned to flexibly dosed therapy with either an oral antipsychotic agent or injectable paliperidone palmitate.

The primary study endpoint was time to treatment failure, broadly defined in this study as a composite of arrest or incarceration; psychiatric hospitalization; suicide; dropout because of insufficient efficacy; discontinuation because of safety or tolerability issues; and the need for treatment supplementation with an additional antipsychotic because of inadequate efficacy, suicide risk, or increased use of psychiatric services in order to prevent imminent psychiatric hospitalization.

Median time to treatment failure was 226 days in the oral antipsychotic group and nearly twice as long at 416 days in the injectable paliperidone palmitate group. The treatment failure rate was 39.8% with paliperidone palmitate, compared with 53.7% with oral antipsychotics. This translated to a 43% greater risk of treatment failure in the oral therapy group, according to Dr. Starr of Janssen Pharmaceuticals in Titusville, N.J.

A prespecified key secondary endpoint was time to first psychiatric hospitalization or arrest/incarceration, as these outcomes are associated with considerable public health impact. The risk of either event proved to be 43% higher in the oral antipsychotic group. Arrest/incarceration and psychiatric hospitalization turned out to be the two most frequently occurring elements of the primary composite endpoint. Arrest/incarceration occurred in 21.2% of the paliperidone group, compared with 29.4% on oral antipsychotics. Eight percent of patients on long-term injectable therapy underwent psychiatric hospitalization, as did 11.9% on oral antipsychotics.

Patients on oral antipsychotic therapy not only experienced arrest/incarceration or psychiatric hospitalization sooner, they also had a significantly greater cumulative number of such events during follow-up.

The study drug was discontinued because of safety or tolerability issues in 6.6% of the paliperidone palmitate group and 3.7% on an oral antipsychotic. Erectile dysfunction was reported by 8.8% of patients on long-acting therapy but none on oral agents. Among women, amenorrhea occurred in 15.2% on paliperidone palmitate, vs. 3.6% on oral antipsychotics.

Thirty-two percent of patients on paliperidone palmitate had at least a 7% weight gain, as did 14% of the oral antipsychotic group.

In the oral antipsychotic group, 22% of patients were on paliperidone; 17%, on risperidone; 16.5%, on olanzapine; 15.1%, on aripiprazole; 13.3%, on quetiapine; 9.2%, on perphenazine; and 6.9%, on haloperidol.

The PRIDE study was funded by Janssen Scientific Affairs, where Dr. Starr serves as director of clinical development.

[email protected]

BERLIN – Once-monthly intramuscular paliperidone palmitate significantly delayed the unwelcome real world consequences of schizophrenia – including contact with the criminal justice system as well as psychiatric hospitalization – compared with oral antipsychotics, in the randomized PRIDE study.

PRIDE, or Paliperidone Palmitate Research in Demonstrating Effectiveness, deliberately enrolled the sort of real world patients with schizophrenia who are familiar to every clinician and jail warden but normally excluded from participation in clinical trials, including patients with a history of arrest and incarceration, and comorbid substance abuse.

Indeed, release from incarceration within the past 90 days was a prerequisite for eligibility for the PRIDE study, Dr. H. Lynn Starr explained at the annual congress of the European College of Neuropsychopharmacology.

Meanwhile, Janssen announced Nov. 13 that the Food and Drug Administration has approved the supplemental new drug applications for the long-acting drug for treating schizoaffective disorder.

PRIDE was a prospective, open-label, multicenter single-blind study in which 450 U.S. schizophrenia patients were randomized to treatment with once-monthly injectable paliperidone palmitate (Invega Sustenna) or daily oral antipsychotics for up to 15 months. Willingness to accept the long-acting injectable medication was a precondition for eligibility. Prior to randomization, patients sat down individually with a clinician, reviewed seven widely prescribed oral antipsychotics available in this study, and eliminated up to six of them from further consideration. They were then randomly assigned to flexibly dosed therapy with either an oral antipsychotic agent or injectable paliperidone palmitate.

The primary study endpoint was time to treatment failure, broadly defined in this study as a composite of arrest or incarceration; psychiatric hospitalization; suicide; dropout because of insufficient efficacy; discontinuation because of safety or tolerability issues; and the need for treatment supplementation with an additional antipsychotic because of inadequate efficacy, suicide risk, or increased use of psychiatric services in order to prevent imminent psychiatric hospitalization.

Median time to treatment failure was 226 days in the oral antipsychotic group and nearly twice as long at 416 days in the injectable paliperidone palmitate group. The treatment failure rate was 39.8% with paliperidone palmitate, compared with 53.7% with oral antipsychotics. This translated to a 43% greater risk of treatment failure in the oral therapy group, according to Dr. Starr of Janssen Pharmaceuticals in Titusville, N.J.

A prespecified key secondary endpoint was time to first psychiatric hospitalization or arrest/incarceration, as these outcomes are associated with considerable public health impact. The risk of either event proved to be 43% higher in the oral antipsychotic group. Arrest/incarceration and psychiatric hospitalization turned out to be the two most frequently occurring elements of the primary composite endpoint. Arrest/incarceration occurred in 21.2% of the paliperidone group, compared with 29.4% on oral antipsychotics. Eight percent of patients on long-term injectable therapy underwent psychiatric hospitalization, as did 11.9% on oral antipsychotics.

Patients on oral antipsychotic therapy not only experienced arrest/incarceration or psychiatric hospitalization sooner, they also had a significantly greater cumulative number of such events during follow-up.

The study drug was discontinued because of safety or tolerability issues in 6.6% of the paliperidone palmitate group and 3.7% on an oral antipsychotic. Erectile dysfunction was reported by 8.8% of patients on long-acting therapy but none on oral agents. Among women, amenorrhea occurred in 15.2% on paliperidone palmitate, vs. 3.6% on oral antipsychotics.

Thirty-two percent of patients on paliperidone palmitate had at least a 7% weight gain, as did 14% of the oral antipsychotic group.

In the oral antipsychotic group, 22% of patients were on paliperidone; 17%, on risperidone; 16.5%, on olanzapine; 15.1%, on aripiprazole; 13.3%, on quetiapine; 9.2%, on perphenazine; and 6.9%, on haloperidol.

The PRIDE study was funded by Janssen Scientific Affairs, where Dr. Starr serves as director of clinical development.

[email protected]