Hamilton Joshua M, Johnston Karen L, Simples Jnr James, Turkoz Ibrahim, Lim Lisa, Antunes Jose, Obando Camilo, Mattingly Gregory
Washington State University, College of Nursing, Department of Advanced Practice & Community-Based Care, Spokane, WA, USA.
Johnson & Johnson, Titusville, NJ, USA.
Neuropsychiatr Dis Treat. 2025 Jun 18;21:1203-1214. doi: 10.2147/NDT.S523687. eCollection 2025.
Long-acting injectable (LAI) formulations of paliperidone palmitate (PP) 1-month-(PP1M), 3-month-(PP3M), and 6-month-(PP6M) have been shown to delay time to relapse and to lower relapse rates, while maintaining symptomatic and functional improvements in patients with schizophrenia. This post-hoc analysis assessed symptomatic and functional remission rates in patients who transitioned from PP3M to PP6M (PP3M/PP6M) or continued PP6M (PP6M/PP6M) over 3 years.
Adult patients with schizophrenia, clinically stable on moderate/high doses of PP1M or PP3M, were randomized to PP6M or PP3M during the 12-month double-blind (DB) phase of a phase-3, noninferiority trial (NCT03345342). Eligible patients who remained relapse-free at the end of the noninferiority trial could choose to continue PP6M in a 2-year, single-arm, open-label extension (OLE) study (NCT04072575). Symptomatic remission was assessed using the Andreasen criteria (Positive and Negative Syndrome Scale symptoms [P1,G9,P3,P2,G5,N1,N4,N6] score of ≤3 for ≥6 months), while functional remission was defined as Personal and Social Performance score >70.
A total of 178 patients either transitioned to PP6M (PP3M/PP6M=57) or continued PP6M (PP6M/PP6M=121) treatment in the OLE study. At the 1-year DB endpoint, 47/57 (82.5%) PP3M/PP6M patients and 103/121 (85.1%) PP6M/PP6M patients achieved symptomatic remission, while 30/57 (52.6%) and 67/121 (55.4%) achieved functional remission, respectively. By the 3-year OLE endpoint, the rates of symptomatic remission (PP3M/PP6M:43/53 [81.1%]; PP6M/PP6M:87/101 [86.1%]) and functional remission (PP3M/PP6M:31/53 [58.5%]; PP6M/PP6M:60/102 [58.8%]) were sustained in both treatment groups. In addition, >56% of patients who transitioned from PP3M to PP6M or continued PP6M treatment had sustained combined (symptomatic and functional) remission at the OLE endpoint.
These findings support the long-term efficacy of PP3M and PP6M, highlighting the potential benefits of transitioning to longer acting antipsychotic formulations in achieving and sustaining both symptomatic stability and functional improvement in adults with schizophrenia.
棕榈酸帕利哌酮（PP）的长效注射（LAI）制剂，即1个月剂型（PP1M）、3个月剂型（PP3M）和6个月剂型（PP6M），已被证明可延迟复发时间并降低复发率，同时维持精神分裂症患者的症状改善和功能改善。这项事后分析评估了在3年时间里从PP3M转换为PP6M（PP3M/PP6M）或继续使用PP6M（PP6M/PP6M）的患者的症状缓解率和功能缓解率。
在一项3期非劣效性试验（NCT03345342）的12个月双盲（DB）阶段，将中度/高剂量PP1M或PP3M治疗下病情临床稳定的成年精神分裂症患者随机分为PP6M组或PP3M组。在非劣效性试验结束时仍未复发的符合条件患者可选择在一项为期2年的单臂开放标签扩展（OLE）研究（NCT04072575）中继续使用PP6M。使用 Andreasen 标准评估症状缓解情况（阳性和阴性综合征量表症状[P1、G9、P3、P2、G5、N1、N4、N6]得分≤3 持续≥6 个月），而功能缓解定义为个人和社会表现得分>70。
共有178例患者在OLE研究中转换为PP6M（PP3M/PP6M = 57）或继续使用PP6M（PP6M/PP6M = 121）治疗。在1年双盲终点时，47/57（82.5%）的PP3M/PP6M患者和103/121（85.1%）的PP6M/PP6M患者实现了症状缓解，而分别有30/57（52.6%）和67/121（55.4%）实现了功能缓解。到3年OLE终点时，两个治疗组的症状缓解率（PP3M/PP6M：43/53 [81.1%]；PP6M/PP6M：87/101 [86.1%]）和功能缓解率（PP3M/PP6M：31/53 [58.5%]；PP6M/PP6M：60/102 [58.8%]）得以维持。此外，在OLE终点时，从PP3M转换为PP6M或继续使用PP6M治疗的患者中，超过56%实现了症状和功能的持续联合缓解。
这些发现支持了PP3M和PP6M的长期疗效，突出了转换为长效抗精神病制剂对于实现并维持成年精神分裂症患者症状稳定性和功能改善的潜在益处。
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