Turkoz Ibrahim, Daskiran Mehmet, Starr H Lynn, Najarian Dean, Lopena Oliver, Obando Camilo, Keenan Alexander, Benson Carmela, Gopal Srihari
Statistics & Decision Sciences, Janssen Research and Development, LLC, Titusville, NJ, USA.
Neuroscience, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Neuropsychiatr Dis Treat. 2022 Aug 30;18:1927-1937. doi: 10.2147/NDT.S373725. eCollection 2022.
This retrospective cohort study evaluated real-world data on relapses in adult patients with schizophrenia who transitioned to long-acting injectable paliperidone palmitate once-every-3-months (PP3M) following treatment with once-monthly paliperidone palmitate (PP1M).
Data derived from the IBM MarketScan Multi-State Medicaid Database were analyzed. Adults aged ≥18 years with ≥1 schizophrenia diagnosis claim and ≥12 months of continuous medical and prescription enrollment before and/or at index date of PP3M were eligible for inclusion. Patients were matched on propensity score to 2 PP3M cohorts: (1) adequately treated (AT), defined as patients treated with PP1M for ≥4 months, with the last 2 doses the same and a PP3M initiation dose meeting the corresponding PP1M-to-PP3M dose conversion, or (2) not adequately treated (NAT), defined as patients who received ≤2 or no PP1M doses. Relapse rates and time to relapse distributions based on the first occurrence of a qualifying event during the 2-year follow-up period were compared between PP3M cohorts using Kaplan-Meier survival curves and log rank test statistics. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. Two sensitivity analyses using different matched populations were performed to assess the robustness of the primary findings.
Propensity score matching yielded a sample of 1314 patients (657 per group). Most patients were male (68.9%) and aged 25-64 years (90.1%). The relapse rate was significantly lower in the AT (18.4%) versus NAT cohort (26.8%), P = 0.0002. Risk of relapse decreased by 35% for AT versus NAT (HR: 0.65 [95% CI: 0.51-0.81]). Relapse reductions favored the AT cohort in both sensitivity analyses (HR: 0.67 [95% CI: 0.54-0.83] and HR: 0.74 [95% CI: 0.56-0.97]).
In this analysis of Medicaid claims data, patients adequately treated with PP1M before transitioning to PP3M demonstrated significantly lower relapse rates and delayed time to relapse.
这项回顾性队列研究评估了成年精神分裂症患者在接受每月一次的棕榈酸帕利哌酮(PP1M)治疗后转为每三个月一次的长效注射用棕榈酸帕利哌酮(PP3M)的复发真实世界数据。
分析了来自IBM MarketScan多州医疗补助数据库的数据。年龄≥18岁、有≥1次精神分裂症诊断记录且在PP3M索引日期之前和/或当日有≥12个月连续医疗和处方登记记录的成年人符合纳入条件。患者根据倾向得分与2个PP3M队列进行匹配:(1)充分治疗(AT)组,定义为接受PP1M治疗≥4个月、最后2剂相同且PP3M起始剂量符合相应PP1M至PP3M剂量转换的患者;(2)未充分治疗(NAT)组,定义为接受≤2剂PP1M或未接受PP1M治疗的患者。使用Kaplan-Meier生存曲线和对数秩检验统计量比较PP3M队列中在2年随访期内首次出现符合条件事件的复发率和复发时间分布。使用Cox比例风险模型计算风险比(HR)和95%置信区间(CI)。进行了两项使用不同匹配人群的敏感性分析,以评估主要研究结果的稳健性。
倾向得分匹配产生了一个1314名患者的样本(每组657名)。大多数患者为男性(68.9%),年龄在25 - 64岁之间(90.1%)。AT组的复发率(18.4%)显著低于NAT组(26.8%),P = 0.0002。与NAT组相比,AT组的复发风险降低了35%(HR:0.65 [95% CI:0.51 - 0.81])。在两项敏感性分析中,复发率降低均有利于AT组(HR:0.67 [95% CI:0.54 - 0.83]和HR:0.74 [95% CI:0.56 - 0.97])。
在这项对医疗补助索赔数据的分析中,在转为PP3M之前接受PP1M充分治疗的患者复发率显著降低且复发时间延迟。