Landmark study shows once-monthly long-acting therapy INVEGA® SUSTENNA® significantly delayed time to relapse in patients with schizophrenia compared to daily oral antipsychotic
Posted: 6 May 2014 | | No comments yet
Janssen Pharmaceuticals, Inc., announced the results of its landmark PRIDE trial…
Janssen Pharmaceuticals, Inc., today announced the results of its landmark PRIDE (Paliperidone Palmitate Research In Demonstrating Effectiveness) trial. PRIDE is the first prospective, randomized clinical trial to compare schizophrenia medications within the context of many “real world” issues in the treatment of schizophrenia, including some of the most challenging circumstances – recent incarceration and substance abuse.
“The PRIDE trial is significant as it is the first to examine the ‘real-world’ consequences of relapse for individuals with schizophrenia,” said Mark Lerman, MD, principal investigator and medical director at the Center for Psychiatric Research at Alexian Brothers Behavioral Health Hospital in Hoffman Estates, Illinois. “The findings indicate that treatment with once-monthly INVEGA® SUSTENNA® significantly delayed time to relapse, as well as reduced overall relapse, compared to the most commonly used treatments, even for patients facing some of the most challenging circumstances.”
INVEGA® SUSTENNA® showed statistical superiority against the primary endpoint, delaying relapse in patients with schizophrenia, as well as in reducing overall relapse, compared to the most commonly used treatments, daily oral antipsychotics (median 416 days vs. median 226 days; P = 0.011). The risk of relapse was 1.4 times higher (95% CI: 1.09, 1.88, P=0.011) in the oral group versus the INVEGA® SUSTENNA® group.
Results of the study will be presented at the 167th Annual Meeting of the American Psychiatric Association (APA) in New York City and support the filing of a supplemental New Drug Application (sNDA) later this year for a U.S. label update.
Continuity of treatment is an ongoing challenge among individuals with schizophrenia, particularly after release from an institution, and lack of access to consistent community care may lead some to cycle through jails or prisons. In addition to the impact on patients, these factors have created an increasingly large and costly problem for the U.S. healthcare system.
“We are pleased and proud to share the results of the PRIDE trial, an example of Janssen’s long-standing commitment to research and development to advance care for people living with schizophrenia,” said Lynn Starr, MD, director of clinical development, Janssen Pharmaceuticals. “The study further demonstrates that INVEGA® SUSTENNA® helps address a critical need for all individuals living with schizophrenia by delaying relapse, even for those patients typically excluded from clinical trials, such as those with a history of incarceration and substance abuse.”
The 15-month U.S. multicenter, prospective, randomized, open-label, event monitoring board-blinded, active-controlled study assessed as its primary endpoint the time to treatment failure, which is a subset of relapse. The endpoint was defined as any one of the following: psychiatric hospitalization; arrest/incarceration; suicide; treatment supplementation or discontinuation of antipsychotic medication because of inadequate efficacy, safety concerns or tolerability issues; or increased level of psychiatric services in order to prevent psychiatric hospitalization.
No new safety issues were observed during the study. The most commonly observed adverse events (AEs) were consistent with those listed in the current U.S. label, including injection site pain, insomnia, weight increase, akathisia, which is restlessness ranging from a feeling of inner distress to an inability to sit still, and anxiety. Among the trial participants, 53 (23.5%) of those taking INVEGA® SUSTENNA® and 9 (4.1%) of those taking oral antipsychotics reported a treatment-emergent prolactin-related AE. Incidence of specific movement disorders associated with antipsychotics was 23.9% in the INVEGA® SUSTENNA® group and 18.8% in the oral antipsychotic group. A ≥7% increase in weight affected 32.4% of subjects in the INVEGA® SUSTENNA® group and 14.4% in the oral antipsychotic group. The study AEs should be evaluated within the context of the trial design and study population.
The study was not powered to compare efficacy of INVEGA® SUSTENNA® with that of individual oral antipsychotics. As with any trial population, results may not be generalized to all persons with schizophrenia.
