Poster
89
(#89) Treatment Effects of Paliperidone Palmitate 6-month Formulation on Negative Symptoms in Patients With Schizophrenia: Post-Hoc Analysis Over 3 Years
Psych Congress 2025
Abstract: Background: Persistent negative symptoms in schizophrenia are a major contributor to long-term functional impairment and disability. Paliperidone palmitate 6-month formulation (PP6M) has demonstrated efficacy in patients with schizophrenia. This post-hoc analysis assessed the effect of PP6M on negative symptoms over 3-years.
Methods: Adult patients previously stabilized on PP1M/PP3M completing 12-month double-blind (DB) phase of noninferiority study (NCT03345342) of PP6M/PP3M without relapse, continued on PP6M in 24-month, open-label extension (OLE; NCT04072575). Improvements in Positive and Negative Syndrome Scale (PANSS) for negative subscale score (PANSS-NSS) and Factor Score for Negative Symptoms (PANSS-FSNS), secondary negative symptoms, and functional improvements over 36-months were assessed in a subset of patients from these relapse prevention studies with prominent negative symptoms.
Results: Of 130 patients (mean[SD] age: 42.8[12.09] years; 71.5% male) with prominent negative symptoms (≥2 negative symptoms items and PANSS-NSS ≥15, [sum N1-N5/N7]), 116 completed DB phase; 31 patients (PP6M/PP6M=23; PP3M/PP6M=8) continued PP6M in OLE. Mean (SE) noninferiority study baseline PANSS-NSS/PANSS-FSNS of 21.29(0.210)/19.84(0.257), n=130, improved at 12-months (DB endpoint) to 19.05(0.322)/17.58(0.304), n=116; mean (SE) change from noninferiority study baseline (CFB): −2.22(0.308)/−2.22(0.322), and maintained through 36-months in OLE to 19.96(0.953)/17.96(0.861), n=25. Secondary negative symptoms factor scores through 36-months did not worsen/remained similar to noninferiority study baseline for Disorganized Thoughts/Uncontrolled Hostility-Excitement/Anxiety-Depression (mean[SE] CFB: −1.04 [0.776]/0.20 [0.392]/−0.20 [0.458], n=25). Functional improvements were observed through 36-months.
Conclusion: In patients with schizophrenia displaying prominent negative symptoms, long-term PP6M treatment in these relapse prevention studies over 3-years maintained improved negative symptoms levels and functional improvements, without secondary negative symptoms' development.
Short Description: Persistent negative symptoms in schizophrenia significantly affect patients' quality of life, social and occupational functioning and can lead to increased disability. In this post-hoc analysis of a subset of patients with schizophrenia displaying prominent negative symptoms, from a 12-month phase-3 study and its 24-month open-label extension, long-term treatment over 3-years with paliperidone palmitate 6-month formulation maintained improved negative symptoms levels and functional improvements, without secondary negative symptoms' development.
Name of Sponsoring Organization(s): Johnson & Johnson
Methods: Adult patients previously stabilized on PP1M/PP3M completing 12-month double-blind (DB) phase of noninferiority study (NCT03345342) of PP6M/PP3M without relapse, continued on PP6M in 24-month, open-label extension (OLE; NCT04072575). Improvements in Positive and Negative Syndrome Scale (PANSS) for negative subscale score (PANSS-NSS) and Factor Score for Negative Symptoms (PANSS-FSNS), secondary negative symptoms, and functional improvements over 36-months were assessed in a subset of patients from these relapse prevention studies with prominent negative symptoms.
Results: Of 130 patients (mean[SD] age: 42.8[12.09] years; 71.5% male) with prominent negative symptoms (≥2 negative symptoms items and PANSS-NSS ≥15, [sum N1-N5/N7]), 116 completed DB phase; 31 patients (PP6M/PP6M=23; PP3M/PP6M=8) continued PP6M in OLE. Mean (SE) noninferiority study baseline PANSS-NSS/PANSS-FSNS of 21.29(0.210)/19.84(0.257), n=130, improved at 12-months (DB endpoint) to 19.05(0.322)/17.58(0.304), n=116; mean (SE) change from noninferiority study baseline (CFB): −2.22(0.308)/−2.22(0.322), and maintained through 36-months in OLE to 19.96(0.953)/17.96(0.861), n=25. Secondary negative symptoms factor scores through 36-months did not worsen/remained similar to noninferiority study baseline for Disorganized Thoughts/Uncontrolled Hostility-Excitement/Anxiety-Depression (mean[SE] CFB: −1.04 [0.776]/0.20 [0.392]/−0.20 [0.458], n=25). Functional improvements were observed through 36-months.
Conclusion: In patients with schizophrenia displaying prominent negative symptoms, long-term PP6M treatment in these relapse prevention studies over 3-years maintained improved negative symptoms levels and functional improvements, without secondary negative symptoms' development.
Short Description: Persistent negative symptoms in schizophrenia significantly affect patients' quality of life, social and occupational functioning and can lead to increased disability. In this post-hoc analysis of a subset of patients with schizophrenia displaying prominent negative symptoms, from a 12-month phase-3 study and its 24-month open-label extension, long-term treatment over 3-years with paliperidone palmitate 6-month formulation maintained improved negative symptoms levels and functional improvements, without secondary negative symptoms' development.
Name of Sponsoring Organization(s): Johnson & Johnson
