Clinical Data Demonstrating Time to Relapse With INVEGA TRINZA®

A long-term maintenance trial demonstrated the efficacy and safety of INVEGA TRINZA® vs placebo1,2

Abbreviated study design1,2
A diagram illustrating an abbreviated visual of INVEGA TRINZA® efficacy, Berwaerts study design

Following stabilization with INVEGA SUSTENNA® (paliperidone palmitate), all patients received 1 dose of INVEGA TRINZA® 12 weeks before randomization in the double-blind phase of the clinical trial.1,2

Indicated for the treatment of schizophrenia

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.

In a long-term maintenance trial,

93% of patients treated with INVEGA TRINZA® remained relapse-free1

Interim analysis primary endpoint:
Longer time to relapse vs placebo1,2
A graph illustrating the clinical data about INVEGA TRINZA® efficacy concerning median time to relapse for patients

Key study observations1,2

  • 7% of patients taking INVEGA TRINZA® relapsed vs 23% of patients taking placebo (P<0.001)1,2
  • Median time to relapse for placebo was 274 days in the double-blind phase1,2
  • Median time to relapse in the INVEGA TRINZA® arm could not be estimated due to low percentage (7.4%) of patients with relapse1,2
  • Due to the significant efficacy of INVEGA TRINZA®, the study was terminated early at the preplanned interim analysis by an Independent Data Monitoring Committee1,2
Final analysis: Demonstrated longer time to relapse vs placebo1,2
A graph illustrating the clinical data about INVEGA TRINZA® efficacy concerning median time to relapse for patients

Key study observations2

  • 9% of patients taking INVEGA TRINZA® relapsed vs 29% of patients taking placebo (P<0.001)2
  • Median time to relapse for placebo was 395 days in the double-blind phase2
  • Median time to relapse in the INVEGA TRINZA® arm could not be estimated due to low percentage of patients with relapse2

Relapse criteria1,2

Relapse was defined as emergence of ≥1 of the following:

  • Psychiatric hospitalization
  • Increase in PANSS total score*
  • Increase in distinct PANSS item scores
  • Deliberate self-injury or violent behavior
  • Suicidal or homicidal ideation

*Defined as a ≥25% increase for 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization or a 10-point increase for patients scoring ≤40 at randomization.

PANSS=Positive and Negative Syndrome Scale.

Indicated for the treatment of schizophrenia

The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5®, or current version), where applicable.

Study design of long-term maintenance trial1,2:

A randomized, double-blind, placebo-controlled, long-term maintenance study compared 3-month paliperidone palmitate (INVEGA TRINZA®) to placebo in adult patients with schizophrenia. Patients were treated for 17 weeks with 1-month paliperidone palmitate (INVEGA SUSTENNA®) during an open-label, flexible-dose stabilization phase, and then a single dose of INVEGA TRINZA® during an open-label maintenance phase. This was followed by a fixed dose of INVEGA TRINZA® or placebo once every 3 months in a variable-duration, double-blind phase. Interim analysis: The study protocol designated that an independent data monitoring committee perform an interim analysis after 42 relapse events had occurred across both arms of the trial. At that point, the committee decided to terminate the study because of the significant difference in efficacy favoring INVEGA TRINZA®, and the interim analysis became the primary efficacy analysis. Final analysis: Between the interim analysis and to the end of the study 22 additional patients were randomized and 14 relapse events occurred across both arms of the trial. Final analysis results—which included these additional patients and relapse events—were consistent with and confirmed the results of the interim analysis. The safety data in the INVEGA TRINZA® label are based on the final analysis.

See significant symptom improvement data in PANSS total scores over time

References: 1. INVEGA TRINZA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; February 2017. 2. Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830-839. Supplemental data available at: http://archpsyc.jamanetwork.com/article.aspx?articleid=2211343#tab12. Accessed June 15, 2017.