FOR US HEALTHCARE PROFESSIONALS ONLY
INVEGA SUSTENNA® demonstrated statistical superiority vs a group of 7 commonly prescribed oral antipsychotics1,2*†
In a 15-month study with a real-world design,‡ INVEGA SUSTENNA® demonstrated:
Primary endpoint
30%
lower risk of first treatment failure3§II
6-month
longer delay in time to relapse1*†§II
Secondary endpoint
Median time to first psychiatric hospitalization or arrest/ incarceration not reached at
15 months1
- 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 was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group1
- The 5 most common adverse events 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%)1
INVEGA SUSTENNA® demonstrated a 6-month longer delay in time to relapse vs a group of oral antipsychotics3
Primary endpoint: Time to first treatment failure in a long-term, randomized, flexible-dose study in adult patients with schizophrenia and a history of incarceration3
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 practice1
59.5%
Patients with comorbid substance abuse1
42.2 days
Mean time since release from last incarceration1
- 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 excluded1
- Percentage of patients who discontinued due to adverse events was 11.9% in the INVEGA SUSTENNA® group and 7.8% in the oral antipsychotic group1
- The 5 most common adverse events 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%)1
Relapse criteria
Time to first treatment failure, defined as 1 of the following1:
- 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
With INVEGA SUSTENNA®, the median time to first psychiatric hospitalization or arrest/incarceration was not reached at 15 months1
Secondary endpoint: Time to first psychiatric hospitalization or arrest/incarceration was significantly longer vs commonly prescribed orals
- 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)1
- Median time to first psychiatric hospitalization or arrest/incarceration in the oral antipsychotic group was 274 days1
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)1
- 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)1,3
- 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 paliperidone palmitate, paliperidone, or risperidone underwent 2-day oral tolerability testing with risperidone, 1 mg QD2
- Oral antipsychotic doses were given and adjusted within the range of the package insert1*
- 17% of adults were diagnosed within 5 years (the mean age of all patients in the study was 38 years [n=444])1,2
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 incarceration3
| Event type | INVEGA SUSTENNA® (n=226) frequency (%) | Oral Antipsychotics (n=218) frequency (%) | Hazard Ratio* [95% Cl] |
|---|---|---|---|
| First treatment failure | 90 (39.8%) | 117 (53.7%) | 0.70 [0.53, 0.92] |
| First treatment failure component events | |||
| Arrest and/or incarceration | 48 (21.2%) | 64 (29.4%) | |
| Psychiatric hospitalization | 18 (8.0%) | 26 (11.9%) | |
| Discontinuation of antipsychotic treatment because of safety or tolerability | 15 (6.6%) | 8 (3.7%) | |
| Treatment supplementation with another antipsychotic because of inadequate efficacy | 5 (2.2%) | 6 (2.8%) | |
| Need for increase in level of psychiatric services to prevent imminent psychiatric hospitalization | 3 (1.3%) | 4 (1.8%) | |
| Discontinuation of antipsychotic treatment because of inadequate efficacy | 1 (0.4%) | 9 (4.1%) | |
| Suicide | 0 | 0 | |
| Arrest and/or incarceration or psychiatric hospitalization events, regardless of whether they were first events† | 76 (33.6%) | 98 (45.0%) | 0.70 [0.52, 0.94] |
Comparative efficacy study design
Comparative 15-month clinical trial in adult patients with schizophrenia designed to reflect real-world issues1,3
*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). Population included adults diagnosed with schizophrenia within 5 years of study entry randomized to 1 of 7 oral antipsychotics.1
Key inclusion criteria1,3
- 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
Primary endpoint3
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 days.1
Real-world design
Real-world design elements
- Included patients who are typically excluded from clinical trials:
- Comorbid substance abuse*
- History of incarceration†
- Unstable living conditions
- Flexible treatment interventions
- OraI antipsychotics could be deselected prior to randomization
- Allowed dosing flexibility and use of concomitant medications
- Medication adherence was monitored but not required to complete the trial
Clinical trial features
- Prospective
- Randomized
- Open-label with blinded Event Monitoring Board
- A 15-month, head-to-head trial vs a group of 7 commonly prescribed oral antipsychotics‡