Psychosis relapse during treatment with long-acting injectable antipsychotics in individuals with schizophrenia-spectrum disorders: an individual participant data meta-analysis.,The Lancet Psychiatry

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Psychosis relapse during treatment with long-acting injectable antipsychotics in individuals with schizophrenia-spectrum disorders: an individual participant data meta-analysis.
The Lancet Psychiatry ( IF 30.8 ) Pub Date : 2020-08-20 , DOI: 10.1016/s2215-0366(20)30264-9
Jose M Rubio ₁ , Georgios Schoretsanitis ₂ , Majnu John ₃ , Jari Tiihonen ₄ , Heidi Taipale ₅ , Daniel Guinart ₂ , Anil K Malhotra ₁ , Christoph U Correll ₆ , John M Kane ₁

Affiliation

Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; Center for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, Manhasset, NY, USA.
Center for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, Manhasset, NY, USA.
Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; Center for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, Manhasset, NY, USA.
Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Stockholm City Council, Stockholm, Sweden.
Department of Forensic Psychiatry, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; School of Pharmacy, University of Eastern Finland, Kuopio, Finland.
Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; Center for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, Manhasset, NY, USA; Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin Berlin, Berlin, Germany.

Background

Most individuals with schizophrenia-spectrum disorders have relapses, which increase the risk of morbidity and mortality. Because non-adherence to antipsychotic maintenance treatment could affect more than half of individuals with schizophrenia-spectrum disorders, psychosis relapse can often be confounded by unnoticed treatment interruption. Research of relapse during confirmed antipsychotic exposure has basic clinical and neurobiological implications, but data are scarce. We aimed to generate reliable estimates of incidence and predictors of relapse during assured antipsychotic treatment.

Methods

We did a systematic review and individual participant data (IPD) meta-analysis of clinical trials of long-acting injectable antipsychotics (LAIs) for psychosis relapse-prevention, following IPD-PRISMA guidelines. Datasets were identified by searching relevant repositories from inception to Aug 1, 2019. Each LAI group was reanalysed as a separate cohort, further identifying subcohorts of individuals with and without prospectively determined symptom remission (PSR). Summary incidence rate of relapse, incidence rate ratios (IRRs) of relapse between individuals with and without PSR, hazard ratios (HRs) of covariates on risk of relapse, and standardised mean difference (SMDs) in changes in overall functioning associated with relapse were generated by pooling results from the harmonised reanalysis of each study. This study is registered with PROSPERO, number CRD42019137439.

Findings

19 treatment cohorts consisting of 5130 individuals (2938 with PSR, 2192 without PSR), with 3959·53 observed participant-years, were meta-analysed. Pooled incidence of relapse was 22·97 per 100 participant-years (14·76 per 100 participant-years for the PSR subcohort, 31·51 per 100 participant-years for the non-PSR subcohort), with an IRR of 0·19 (95% CI 0·07 to 0·54). Relapse was associated with functional decline (overall SMD −0·76, 95% CI −1·14 to −0·37; PSR SMD −0·52, 95% CI −0·80 to −0·21; non-PSR SMD −0·72, 95% CI −1·18 to −0·26). The strongest predictor of relapse was tardive dyskinesia at treatment onset (HR 2·39, 95% CI 1·05 to 5·42).

Interpretation

Despite the established efficacy of antipsychotics in preventing relapse, these data indicate that these drugs might not prevent subsequent exacerbations for a proportion of individuals whose illness is stabilised on continuous antipsychotic treatment. Tardive dyskinesia in particular might have pathophysiological implications for relapse.

Funding

Northwell Health.

中文翻译：

长效注射抗精神病药治疗患有精神分裂症-频谱障碍的个体中的精神病复发：个体参与者数据荟萃分析。

背景

大多数患有精神分裂症-频谱疾病的人都会复发，从而增加发病和死亡的风险。由于不坚持抗精神病药物维持治疗可能会影响超过一半的精神分裂症患者，因此精神病的复发通常会因未引起注意的治疗中断而混淆。已证实的抗精神病药物暴露期间复发的研究具有基本的临床和神经生物学意义，但数据很少。我们旨在生成可靠的抗精神病药物治疗期间的发病率和复发预测指标的可靠估计。

方法

我们按照IPD-PRISMA指南对长效可注射抗精神病药（LAIs）预防精神病复发的临床试验进行了系统回顾和个人参与者数据（IPD）荟萃分析。从开始到2019年8月1日，通过搜索相关的存储库来识别数据集。每个LAI组作为一个单独的队列进行重新分析，进一步确定患有和未患有预期的症状缓解（PSR）的个体的亚队列。汇总了复发的发生率，有或没有PSR的个体之间的复发发生率（IRR），有关复发风险的协变量的危险比（HRs）以及与复发相关的总体功能变化的标准化均值（SMD）通过汇总每个研究的统一再分析结果得出结果。该研究已在PROSPERO注册，

发现

荟萃分析了19个治疗队列，包括5130个个体（2938个有PSR，2192个无PSR）和3959·53个观察者-年。复发的合并发生率为每100参与者年22·97（PSR子队列为14·76每100参与者年，非PSR子群体为每100参与者年31·51），IRR为0·19 （95％CI 0·07至0·54）。复发与功能下降有关（总体SMD -0·76，95％CI -1·14至-0·37; PSR SMD -0·52，95％CI -0·80至-0·21;非PSR SMD -0·72，95％CI -1·18至-0·26）。复发的最强预测因子是治疗开始时的迟发性运动障碍（HR 2·39，95％CI 1·05至5·42）。