FOR US HEALTHCARE PROFESSIONALS ONLY
A noninferiority study compared INVEGA TRINZA® to INVEGA SUSTENNA®
In the study, INVEGA TRINZA® delayed relapse as effectively as INVEGA SUSTENNA®1
Primary endpoint
At Week 48*
91%
of patients taking
INVEGA TRINZA®
VS
90%
of patients taking
INVEGA SUSTENNA®
remained relapse-free1
Secondary endpoint
Mean PANSS total scores were similar for INVEGA SUSTENNA® and INVEGA TRINZA® over time during the double-blind phase1
Nearly 60% of patients in both groups demonstrated symptomatic remission† during the last 6 months of the double-blind phase1‡
- During the double-blind phase, 3% of patients in each group discontinued treatment due to adverse events.
- The most common treatment-emergent adverse events (≥5%) in either group during the double-blind phase were increased weight (21% in both groups), nasopharyngitis (INVEGA TRINZA®: 7%; INVEGA SUSTENNA®: 6%), anxiety (5% in both groups), and headache (INVEGA TRINZA®: 4%; INVEGA SUSTENNA®: 5%)
INVEGA TRINZA® was noninferior to INVEGA SUSTENNA® after the 48-week double-blind phase1
Primary endpoint: time to first relapse
- During the double-blind phase, 3% of patients in each group discontinued treatment due to adverse events1
- The most common treatment-emergent adverse events (≥5%) in either group during the double-blind phase were increased weight (21% in both groups), nasopharyngitis (INVEGA TRINZA®: 7%; INVEGA SUSTENNA®: 6%), anxiety (5% in both groups), and headache (INVEGA TRINZA®: 4%; INVEGA SUSTENNA®: 5%)
Relapse criteria
Occurrence of 1 or more of the following:
- Hospitalization for schizophrenia symptoms (involuntary or voluntary admission)
- 25% increase in PANSS total score from randomization on 2 consecutive assessments between 3 and 7 days apart for patients scoring >40 at randomization, or a 10-point increase of patients scoring ≤40 at randomization
- Increase in distinct PANSS item scores (P1, P2, P3, P6, P7, or G8) for 2 consecutive assessments between 3 and 7 days apart
- Clinically significant, deliberate self-injury or violent behavior resulting in suicide, injury, or significant damage
- Suicidal or homicidal ideation and aggressive behavior
INVEGA TRINZA® achieved similar improvements as INVEGA SUSTENNA® in mean PANSS total scores in the double-blind phase1
Secondary endpoint: change in mean PANSS total score over time
- Double-blind phase: Only patients who were clinically stable* entered the double-blind phase—and they still reported continued improvements in both treatment groups
- The mean baseline PANSS total score for patients entering the double-blind phase in the INVEGA SUSTENNA® group was 58.1, and these patients saw an improvement of -4.3. Patients entering the double-blind phase in the INVEGA TRINZA® group had a mean baseline score of 57.4 and saw an improvement of -3.5
Patients showed symptomatic remission during the last 6 months of the double-blind phase1
Nearly 6 out of 10 patients in both the INVEGA TRINZA® and INVEGA SUSTENNA® arms showed symptomatic remission*
- 59% of patients taking INVEGA SUSTENNA® and 58% of patients taking INVEGA TRINZA® showed symptomatic remission for the last 6 months of the double-blind phase
- Symptomatic remission was defined by the Andreasen remission criteria
Study design: 48-week, randomized, double-blind noninferiority trial1
- The prespecified noninferiority margin was -15%
- After a 3-week screening period for oral tolerability testing/washout, patients entered a 17-week open-label stabilization phase (5 doses of INVEGA SUSTENNA®). Clinically stable patients (n=1,016) were then randomized in the double-blind phase to continue receiving INVEGA SUSTENNA® or start on INVEGA TRINZA®
Study criteria
Key Inclusion Criteria
- Adult patients (men and women, ages 18-70 years) with a diagnosis of schizophrenia (according to the DSM-IV®), a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 at screening and baseline, and worsening of symptoms
- Patients who discontinued other antipsychotics due to insufficient efficacy, safety, or tolerability issues with current therapy, or with preferences for injectable medications
- Women included in the study were postmenopausal, surgically sterile, or used adequate contraception, and eligible men used adequate contraception
Key exclusion Criteria
- Active DSM-IV® diagnosis other than schizophrenia
- Significant risk of suicidal behavior
- History of substance dependence within 6 months before screening
- Involuntary status in a psychiatric hospital at screening
- History of neuroleptic malignant syndrome, tardive dyskinesia, or any unstable or significant medical or neurological illness
- Morbid obesity (BMI >40 kg/m2)
- Other systemic disease, mental retardation, risk factors for prolonged QT interval, torsades de pointes, or sudden death
- History of intolerability, hypersensitivity, or lack of response to risperidone or paliperidone
- Taking any long-acting injectable antipsychotics within 4 weeks before screening
Reference: 1. Savitz AJ, Xu H, Gopal S, et al. Efficacy and safety of paliperidone palmitate 3-month formulation for patients with schizophrenia: a randomized, multicenter, double-blind, noninferiority study. Int J Neuropsychopharm. 2016;19(7):1-14.