INVEGA SUSTENNA® is approved for the treatment of schizoaffective disorder

A Comparative Efficacy Study With a Real-World Design: INVEGA SUSTENNA® vs Commonly Prescribed Oral Antipsychotics in Patients With Schizophrenia and a History of Incarceration1,2*

In the 15-month study:

INVEGA SUSTENNA® significantly delayed time to first treatment failure >6 months longer than commonly prescribed oral antipsychotics1

Primary endpoint: Time to first treatment failure for INVEGA SUSTENNA® vs commonly prescribed oral antipsychotics1
A diagram illustrating a visual of comparative efficacy study with delayed time to first treatment failure with INVEGA SUSTENNA®

Real-world as defined by patient selection and clinically meaningful outcome measures.1

*The 7 oral antipsychotics (included in the comparative arm) account for 74% of oral schizophrenia treatment.3

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).1

  • Median time to first treatment failure in the INVEGA SUSTENNA® group was 416 days vs 226 days in the oral antipsychotic group1
  • Fewer patients experienced a treatment failure event taking INVEGA SUSTENNA® vs those patients taking oral antipsychotics (39.8% vs 53.7%, respectively)1

The study was not powered to compare the efficacy of INVEGA SUSTENNA® with that of individual oral antipsychotics.

Time to first treatment failure, defined as 1 of the following1:

  • Psychiatric hospitalization
  • Arrest/incarceration
  • Discontinuation of antipsychotic treatment due to safety or tolerability concerns
  • Treatment supplementation with another antipsychotic due to inadequate efficacy
  • Increased psychiatric services to prevent an imminent psychiatric hospitalization
  • Discontinuation of antipsychotic treatment due to inadequate efficacy
  • Suicide

Secondary endpoint:

Time to First Psychiatric Hospitalization or Arrest/Incarceration Was Significantly Longer With INVEGA SUSTENNA® Than With Commonly Prescribed Oral Antipsychotics1

Secondary endpoint: Median time to first psychiatric hospitalization or arrest/incarceration1
A diagram illustrating a visual of comparative efficacy study with delayed hospitalization/arrest with INVEGA SUSTENNA®
  • 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 days1

A 15-month comparative efficacy study of INVEGA SUSTENNA® vs commonly prescribed oral antipsychotics1

Abbreviated study design1
A diagram illustrating an abbreviated visual of INVEGA SUSTENNA® efficacy, a comparative efficacy study design
  • 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)1
    • Flexible monthly maintenance dosing for INVEGA SUSTENNA® was started on day 38 within a range of 78 mg to 234 mg (recommended target maintenance dose was 156 mg)1
    • Before randomization, each patient and the treating clinician could deselect up to 6 of the 7 oral antipsychotics based on prior patient experience1
    • Patients not previously treated with INVEGA SUSTENNA®, INVEGA® (paliperidone), or oral risperidone underwent 2-day oral tolerability testing with risperidone 1 mg once daily3
  • Oral antipsychotic doses were given and adjusted within the range of the package insert1
  • 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])1,3

Occasional dosing outside of the package insert range was allowed.

Paliperidone Palmitate Research in Demonstrating Effectiveness Study (N=444)1-3
A graph illustrating acomparative efficacy study for INVEGA SUSTENNA® which is aimed to reflect issues with treatment of schizophrenia patients

Real-world as defined by patient selection and clinically meaningful outcome measures.1

The 39-mg strength was not studied in the comparative efficacy study.1

§The 7 oral antipsychotics (included in the comparative arm) account for 74% of oral schizophrenia treatment.3

Except for patients who had abused intravenous drugs within 3 months of screening or had an opiate dependence disorder (DSM-IV®).1

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

Key patient characteristics1

  • Mean age: 38.1 years
  • Patients with comorbid substance abuse: 59.5%
  • Mean time since release from last incarceration: 42.2 days

Key inclusion/exclusion criteria

Key inclusion criteria1:

  • 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 criteria1:

  • 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

Safety and tolerability of INVEGA SUSTENNA® vs commonly prescribed oral antipsychotics1,4

Select treatment-emergent adverse events1
A graph illustrating potential INVEGA SUSTENNA® (paliperidone palmitate) adverse reactions and other tolerability information, comparative efficacy study

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).

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

References: 1. 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. 2. Landmark study shows once-monthly long-acting therapy INVEGA® SUSTENNA® (paliperidone palmitate) significantly delayed time to relapse in patients with schizophrenia compared to daily oral antipsychotic [press release]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; May 5, 2014. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. IMS Real-World Data. May 2010-December 2013. 4. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; March 2018.

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