棕榈酸帕利哌酮6个月长效注射剂与棕榈酸帕利哌酮3个月长效注射剂治疗欧洲精神分裂症患者的疗效和安全性：一项全球3期双盲随机非劣效性研究的事后分析
Efficacy and Safety of Paliperidone Palmitate 6-Month versus Paliperidone Palmitate 3-Month Long-Acting Injectable in European Patients with Schizophrenia: A Post Hoc Analysis of a Global Phase-3 Double-Blind Randomized Non-Inferiority Study.
作者信息
Giron-Hernandez Cesar, Han Joong Hee, Alberio Roberta, Singh Arun, García-Portilla Maria Paz, Pompili Maurizio, Knight R Karl, Richarz Ute, Gopal Srihari, Antunes José
机构信息
EMEA Medical Affairs, Janssen-Cilag, Issy-les-Moulineaux, France.
Janssen Research & Development, LLC, Titusville, NJ, USA.
出版信息
Neuropsychiatr Dis Treat. 2023 Apr 13;19:895-906. doi: 10.2147/NDT.S400342. eCollection 2023.
PURPOSE
To examine efficacy and safety of paliperidone palmitate (PP) 6-month (PP6M) vs PP3-month (PP3M) long acting injectable (LAI) in patients with schizophrenia from European sites previously stabilized on PP3M or PP1-month (PP1M).
METHODS
This post-hoc subgroup analysis used data from a global phase-3 double-blind (DB) randomized non-inferiority study (NCT03345342). Patients were randomized (2:1, respectively) to receive dorsogluteal injections of PP6M (700 mg eq. or 1000 mg eq.) or PP3M (350 mg eq. or 525 mg eq.) in the 12-month DB phase. Primary endpoint was time-to-relapse during the DB phase, using a Kaplan-Meier cumulative survival estimate (non-inferiority margin 95% CI lower bound larger than prespecified as -10%). Treatment emergent adverse events (TEAEs), physical examinations, and laboratory tests were also evaluated.
RESULTS
A total of 384 patients who entered the DB phase were included in European sites (PP6M, n = 260; PP3M, n = 124) with a mean age similar in both groups (mean age [SD] years: PP6M, 40.0 [11.39]; PP3M, 38.8 [10.41]). Baseline characteristics were similar across both groups. The number of patients who experienced a relapse during DB phase were PP6M: 18 (6.9%) vs PP3M: 3 (2.4%) with percentage relapse-free difference of -4.9% (95% CI: -9.2%, -0.5%), thus achieving non-inferiority criteria. Secondary efficacy endpoints indicated comparable improvements. Incidence of TEAEs was similar between PP6M (58.8%) and PP3M (54.8%) groups. Nasopharyngitis, headache, increased weight, and injection-site pain were the most common TEAEs.
CONCLUSION
The efficacy of PP6M was non-inferior to that of PP3M in preventing relapse in the European subgroup previously treated with PP1M or PP3M, which was consistent with the global study. No new safety signals were identified.
目的
在欧洲地区曾使用棕榈酸帕利哌酮（PP）3个月或1个月长效注射剂（LAI）病情已稳定的精神分裂症患者中，比较6个月棕榈酸帕利哌酮（PP6M）与3个月棕榈酸帕利哌酮（PP3M）长效注射剂的疗效和安全性。
方法
本事后亚组分析使用了一项全球3期双盲（DB）随机非劣效性研究（NCT03345342）的数据。在12个月的双盲阶段，患者被随机分组（分别为2:1），接受臀肌注射PP6M（700毫克当量或1000毫克当量）或PP3M（350毫克当量或525毫克当量）。主要终点是双盲阶段的复发时间，采用Kaplan-Meier累积生存估计（非劣效性界值95%CI下限大于预先设定的-10%）。还评估了治疗中出现的不良事件（TEAE）、体格检查和实验室检查。
结果
共有384名进入双盲阶段的患者被纳入欧洲地区的研究（PP6M组，n = 260；PP3M组，n = 124），两组的平均年龄相似（平均年龄[标准差]岁：PP6M组，40.0[11.39]；PP3M组，38.8[10.41]）。两组的基线特征相似。双盲阶段出现复发的患者人数分别为：PP6M组18例（6.9%），PP3M组3例（2.4%），无复发百分比差异为-4.9%（95%CI：-9.2%，-0.5%），因此达到非劣效性标准。次要疗效终点显示改善情况相当。PP6M组（58.8%）和PP3M组（54.8%）的TEAE发生率相似。鼻咽炎、头痛、体重增加和注射部位疼痛是最常见的TEAE。
结论
在欧洲曾接受PP1M或PP3M治疗的亚组中，PP6M预防复发的疗效不劣于PP3M，这与全球研究结果一致。未发现新的安全信号。
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