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Randomized trial indicates Invega Sustenna superior to oral antipsychotics in delaying schizophrenia treatment failure

Results from a randomized, multicenter study indicate that once monthly Invega Sustenna was superior to oral antipsychotics in delaying treatment failure among adults with schizophrenia.

“Poor treatment adherence is common among individuals with schizophrenia, particularly in patients with prior involvement with the criminal justice system or comorbid substance abuse. Such problems with adherence is frequently a precursor to cycles of relapse and recidivism,” study researcher Larry Alphs, MD, PhD, of Janssen Scientific Affairs, and colleagues wrote.

To assess efficacy and safety of Invega Sustenna (paliperidone palmitate, Janssen Pharmaceuticals) in “real-world management of schizophrenia,” researchers randomized 450 patients to receive paliperidone palmitate or oral antipsychotics for 15 months. Study participants were aged 18 to 65 years, diagnosed with schizophrenia and had been taken into custody by the criminal justice system at least two times in the last two years with at least one of those events leading to incarceration. Paliperidone palmitate was administered intravenously in a flexible dose of 78 to 234 mg. During the 15-month study period, study visits occurred on days 8, 15, 38 and monthly thereafter.

Overall, 39.8% of patients who received paliperidone palmitate and 53.7% of patients who received oral antipsychotics experienced treatment failure. However, patients who received paliperidone palmitate had more delayed treatment failure compared with patients who received oral antipsychotics (HR = 1.43; 95% CI, 1.09-1.88). Median time to first treatment failure was 416 days among patients in the paliperidone palmitate group and 226 days in the oral antipsychotics group.

During the study period, psychiatric hospitalization or arrest/incarceration occurred among 33.6% of patients in the paliperidone palmitate group vs. 45% of patients in the oral antipsychotics group. Patients who received paliperidone palmitate had more delayed psychiatric hospitalizations or arrests/incarcerations compared with patients who received oral antipsychotics (HR = 1.43; 95% CI, 1.06-1.93).

There were no significant differences between treatment groups regarding Personal and Social Performance Scale or Clinical Global Impressions-Severity of Illness scale scores, according to researchers.

Severe adverse events occurred among 85.8% of patients who received paliperidone palmitate and 79.8% of those who received oral antipsychotics. Pain at injection site, insomnia, weight increase, akathisia and anxiety were the most commonly reported adverse events in the paliperidone palmitate group.

“[These] study results demonstrated that once-monthly treatment with paliperidone palmitate was more effective in delaying treatment failure versus daily oral antipsychotics (median difference 190 days) in a trial designed to reflect the real-world management of schizophrenia subjects at risk for treatment failure,” Alphs and colleagues concluded. – by Amanda Oldt

Disclosure: Alphs reports he is an employee of Janssen Scientific Affairs, LLC and owns stock in Johnson & Johnson. Please see the full study for a list of all other authors’ relevant financial disclosures.