EPA-1547 - Once monthly paliperidone palmitate – tolerability and treatment response in recently diagnosed versus chronic non-acute schizophrenia patients switched from previously unsuccessful treatment with oral antipsychotics

Abstract

To explore tolerability and treatment response of flexibly dosed once-monthly paliperidone palmitate (PP) in recently diagnosed versus chronic adult non-acute schizophrenia patients previously unsuccessfully treated with oral antipsychotics. International prospective 6-month open-label study. Patients were stratified by years since diagnosis [≤3 versus >3 years]. Outcomes were changes from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression- Change Scale (CGI-C), Extrapyramidal Symptom Rating Scale (ESRS) and treatment-emergent adverse events (TEAEs). N=233 recently diagnosed (63.9% male, mean age 32.2±10.3 years, mean time since diagnosis 1.2±0.9 years) and n=360 chronic patients (62.5% male, mean age 42.4±11.0, mean time since diagnosis 13.9±9.3 years) were included. 71% of recently diagnosed and 59% of chronic patients showed a ≥20% improvement in PANSS total score at endpoint. Mean changes in PANSS total score at endpoint were - 15.1±15.6 and -9.6±15.7, respectively (between-group difference p<0.0001). Changes in PANSS positive, negative and general subscores were consistently higher in recently diagnosed patients (all p≤0.001). At endpoint, 52.4% of recently diagnosed patients were rated much or very much improved on CGI-C compared to 38.1% in the chronic group (p=0.0008). TEAEs ≥5% in both subgroups (recently diagnosed and chronic) were injection site pain (12.9% vs. 11.9%), insomnia (9.9% vs. 7.8%), anxiety (6.4% vs. 6.9%), and headache (6.0% vs.5.3%). These data suggest that both recently diagnosed and chronic patients previously unsuccessfully treated with oral antipsychotics benefit from paliperidone palmitate, with recently diagnosed patients showing consistently higher treatment response and lower disease severity at endpoint.