MAKE ABILIFY MAINTENA® (aripiprazole) YOUR FIRST-CHOICE LAI* FOR ADULT PATIENTS WITH SCHIZOPHRENIA
*Establish tolerability with oral aripiprazole before initiating therapy. For patients already stable on oral aripiprazole or
LAI=long-acting injectable.
12-week Short-term Study
Screening Phase
Before study enrollment, 26.5% of patients were on no antipsychotic, 22% on another antipsychotic, 21.5% on risperidone, 15.3% on quetiapine, 8.2% on olanzapine, and 6.5% on aripiprazole. Percentages provided were patient-reported estimations. All patients underwent a 7‑day washout period at trial entry.1,2
Patients without prior exposure received oral aripiprazole to establish tolerability.
Study Design
12-week, randomized, double-blind, placebo-controlled study evaluated acutely relapsed† adult patients with schizophrenia1:
- Patients were randomized to either
ABILIFY MAINTENA (n=168) or intramuscular placebo (n=172) - After initial injection, patients received 14 days of oral aripiprazole or oral placebo based on treatment arm
- Safety was assessed throughout the duration of the study
- Primary endpoint was mean change in PANSS Total Score from baseline to Week 10
†Baseline characteristics: PANSS Total Score ≥80 and a PANSS score >4 on each of 4 specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content) at screening and baseline; diagnosis of schizophrenia ≥1 year.1
Primary efficacy endpoint: Mean change in PANSS Total Score from baseline to Week 101
Statistically significant improvement in PANSS Total Score vs placebo as early as Week 1 and through Week 121
PANSS=Positive and Negative Syndrome Scale.
Contraindication:
Known hypersensitivity reaction to aripiprasole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
52-week Maintenance Study
Study Design
52-week, multiphase study evaluated the time to relapse for adult patients with schizophrenia diagnosed ≥3 years with a history of symptom exacerbation or relapse when not receiving antipsychotic treatment (DSM-IV-TR criteria)3‡
- Open-label Phase 1: Patients were converted to oral aripiprazole
- Open-label Phase 2: Patients were stabilized on oral aripiprazole 10 mg to 30 mg/day
- Single-blind Phase 3: Patients were converted to and stabilized on
ABILIFY MAINTENA 400 mg. Patients continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initialABILIFY MAINTENA dose - Double-blind Phase 4: Patients were randomized to either
ABILIFY MAINTENA (n=269) or intramuscular placebo (n=134) - Primary endpoint was time from randomization to relapse
‡Relapse was defined as clinical worsening, psychiatric hospitalization, increased risk of suicide, or violent behavior.3
Primary endpoint: Time from randomization to relapse3
ABILIFY MAINTENA significantly delayed time to relapse‡ vs placebo (HR=0.199 [95% CI, 0.1-0.3], P<0.0001)3,4§
The hazard ratio was used to calculate the reduction in risk of relapse for patients on
‡Relapse was defined as clinical worsening, psychiatric hospitalization, increased risk of suicide, or violent behavior.3
§This figure is based on a total of 80 relapse events.
Key secondary endpoint: Percent of patients meeting relapse criteria3‡
The percent of patients who relapsed was 4x higher on placebo than ABILIFY MAINTENA (HR=5.03 [95% CI, 3.15-8.02])3
CI=confidence interval; HR=hazard ratio.
‡Relapse was defined as clinical worsening, psychiatric hospitalization, increased risk of suicide, or violent behavior.3
Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including Stroke:
Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
References: 1. Kane JM, Peters-Strickland T, Baker RA, et al. Aripirazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260. 2. Data on file. ABIMAI-122. 3. Kane JM, Sanchez R, Perry PP, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(5):617-624. 4. Data on file. ABIMAI-027.