INVEGA SUSTENNA® Demonstrated Statistical Superiority vs a Group of 7 Commonly Prescribed Oral Antipsychotics in Adult Patients With Schizophrenia*†

In a 15-month study with a real-world design, INVEGA SUSTENNA® demonstrated:

comparative efficacy overview
  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
  • Percentage of patients who discontinued due to adverse events (AEs) was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group2
  • The 5 most common AEs in the INVEGA SUSTENNA® group were injection-site pain (18.6%), insomnia (16.8%), weight increase (11.9%), akathisia (11.1%), and anxiety (10.6%)2

*Data from randomization until end of randomly assigned treatment (28 days after last injection of INVEGA SUSTENNA® or 1 day after last dose of oral antipsychotic). Population included adults diagnosed with schizophrenia within 5 years of study entry randomized to 1 of 7 oral antipsychotics.2

†Real-world as defined by patient selection and clinically meaningful outcome measures.

‡The 7 oral antipsychotics included in the comparative arm accounted for 74% of oral schizophrenia treatment during the study period.3

§Relapse was defined as time to first treatment failure.1

¶Median time to first treatment failure in the INVEGA SUSTENNA® group was 416 days vs 226 days in the oral antipsychotic group.1

Abbreviated Study Design:

Comparative 15-month clinical trial in adult patients with schizophrenia designed to reflect real-world issues.1,2

comparative efficacy study design

*Data from randomization until end of randomly assigned treatment (28 days after last injection of INVEGA SUSTENNA® or 1 day after last dose of oral antipsychotic). Population included adults diagnosed with schizophrenia within 5 years of study entry randomized to 1 of 7 oral antipsychotics.2

Primary Endpoint:

Time to first treatment failure in a long-term, randomized, flexible-dose study in adult patients with schizophrenia and a history of incarceration1

comparative efficacy primary endpoint

Select real-world† patient characteristics relevant to clinical practice‡ included adults living with schizophrenia often excluded from trials to compare how antipsychotics work in clinical practice2

59.5%—Patients with comorbid substance abuse
42.2 days—Mean time since release from last incarceration

  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
  • Substance abuse was not exclusionary, but subjects who had abused intravenous drugs within 3 months of screening or had an opiate dependence disorder (DSM-IV®) were excluded
  • Percentage of patients who discontinued due to AEs was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group2
  • The 5 most common AEs in the INVEGA SUSTENNA® group were injection-site pain (18.6%), insomnia (16.8%), weight increase (11.9%), akathisia (11.1%), and anxiety (10.6%)

†Real-world as defined by patient selection and clinically meaningful outcome measures.

‡The 7 oral antipsychotics included in the comparative arm accounted for 74% of oral schizophrenia treatment during the study period.3

Secondary Endpoint

Time to first psychiatric hospitalization or arrest/incarceration was significantly longer vs commonly prescribed orals

comparative efficacy secondary endpoint
  • The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics
  • Median time to first psychiatric hospitalization or arrest/incarceration was not reached in the INVEGA SUSTENNA® group (>450 days)
  • Median time to first psychiatric hospitalization or arrest/incarceration in the oral antipsychotic group was 274 days2

Study Notes

Adult patients assigned to the INVEGA SUSTENNA® group were initiated with 2 injections in the deltoid muscle that were given approximately 1 week apart: 234 mg on Day 1 and 156 mg on Day 8 (±4 days)2

  • Flexible monthly maintenance dosing for INVEGA SUSTENNA® was started on Day 38 within a range of 78 mg to 234 mg (median dose was 156 mg)1,2
  • Before randomization, each patient and the treating clinician could deselect up to 6 of the 7 oral antipsychotics based on prior patient experience2
  • Patients not previously treated with paliperidone palmitate, paliperidone, or risperidone underwent 2-day oral tolerability testing with risperidone, 1 mg QD3
  • Oral antipsychotic doses were given and adjusted within the range of the package insert2*
  • 17% of adults were diagnosed within 5 years, with a mean age of 32 years (the mean age of all patients in the study was 38 years [n=444])2,4

*Occasional dosing outside of the package insert range was allowed.

Real-world Design Elements

real world design elements

*The 7 oral antipsychotics included in the comparative arm accounted for 74% of oral schizophrenia treatment during the study period.3

†Except for patients who had abused intravenous drugs within 3 months of screening or had an opiate-dependence disorder (DSM-IV®).2

‡Patients must have been arrested ≥2 times in the previous 2 years, with ≥1 event leading to incarceration; released from most recent custody within 90 days of the screening visit.2

Key Inclusion Criteria1,2:

  • Adults (18 to 65 years old)
  • Current diagnosis of schizophrenia (DSM-IV® criteria)
  • Patients must have been taken into criminal justice system custody ≥2 times in the previous 2 years, with ≥1 of these events leading to incarceration
  • Released from most recent custody within 90 days of screening

Key Exclusion Criteria2:

  • Use of clozapine within 3 months of screening or an injectable antipsychotic within 2 injection cycles of screening
  • Substance abuse was not exclusionary, but subjects who had abused intravenous drugs within 3 months of screening or had an opiate dependence disorder (DSM-IV®) were excluded

Relapse Criteria

Time to first treatment failure, defined as 1 of the following:

  • Psychiatric hospitalization
  • Arrest/Incarceration
  • Discontinuation of antipsychotic treatment because of safety or tolerability concerns
  • Treatment supplementation with another antipsychotic because of inadequate efficacy
  • Increase in level of psychiatric services to prevent an imminent psychiatric hospitalization
  • Discontinuation of antipsychotic treatment because of inadequate efficacy
  • Suicide

Primary Endpoint1

Median time to first treatment failure in the INVEGA SUSTENNA® group was 416 days vs 226 days in the oral antipsychotic group.

Secondary Endpoint1

  • Median time to first psychiatric hospitalization or arrest/incarceration was not reached in the INVEGA SUSTENNA® group (>450 days). Median time to first psychiatric hospitalization or arrest/incarceration in the oral antipsychotic group was 274 days2
  • Time to first psychiatric hospitalization or arrest/incarceration1

Frequencies of First Treatment Failure Events by Type

Components of composite endpoint in a long-term, randomized, flexible-dose study in subjects with schizophrenia and a history of incarceration1

composite endpoint

QD=every day

*Hazard ratio of INVEGA SUSTENNA® to oral antipsychotics based on Cox regression model for time-to-event analysis. Note that the hazard ratio did not appear constant throughout the trial.

†Analysis results, which incorporated relevant events collected after discontinuation for those who discontinued, were consistent with the results from the prespecified analysis of this secondary endpoint.

References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019. 2. Alphs L, Benson C, Cheshire-Kinney K, et al. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board–blinded 15-month study. J Clin Psychiatry. 2015;76(5):554-561. 3. IMS Real World Data. May 2010-December 2013. 4. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.