Most Patients With Schizophrenia Relapse-Free With Paliperidone Palmitate, Open Label Extension Study Finds

In a 2-year open-label extension study of a 1-year randomized clinical trial, 95.6% of the participating patients with schizophrenia being treated with paliperidone palmitate (PP) remained relapse free for up to 3 years. Results from the study were published in JAMA Network Open.

“The low rate of relapse reported in this study highlights the important role that long-acting injectable (LAI) antipsychotics have as a treatment that can facilitate and support the recovery process,” said Christoph U. Correll, MD, department of psychiatry, Zucker Hillside Hospital, Glen Oaks, New York, and co-authors. “In this regard, treatments such as PP every 6 months can play a potentially important role in long-term recovery in patients with schizophrenia.”

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The open-label extension study included 121 patients who opted to continue their PP treatment after not experiencing relapse during the 1-year international, multicenter, double-blind, randomized noninferiority trial. These patients continued receiving PP once every 6 months for up to 30 months. Study endpoints included relapse assessment as well as score changes on the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Severity (CGI-S) Scale, and Personal Social Performance (PSP), as compared to the double-blind trial baseline.

Of the 121 patients, 5 (4.1%) experienced relapse during the 3-year follow up period. The remaining patients receiving regular PP treatment “were clinically and functionally stable, and outcomes were well maintained” according to scores across the assessment tools (PANSS [mean (SD) change, −2.6 [9.96] points], CGI-S [mean (SD) change, −0.2 (0.57) points], and PSP [mean (SD) change, 3.1 (9.14) points]).

Additionally, 97 (80.2%) of the patients reported at least 1 treatment-emergent adverse event, though authors noted that no new safety or tolerability concerns arose throughout the study.

The authors noted some limitations to their study, including the lack of a comparator group and potential confounding demographic factors.

Reference

Correll CU, Johnston K, Turkoz I, et al. Three-year outcomes of 6-month paliperidone palmitate in adults with schizophrenia: An open-label extension study of a randomized clinical trial. JAMA Netw Open. 2024;7(7):e2421495. doi: 10.1001/jamanetworkopen.2024.21495