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在一项长期临床研究中,接受每月一次长效利培酮治疗的精神分裂症患者的患者报告结局。

Patient-reported outcomes in schizophrenia patients treated with once-monthly extended-release risperidone in a long-term clinical study.

作者信息

Dhanda Rahul, Varghese Della, Nadipelli Vijay R, Fava Maurizio, Joshi Namita, Solem Caitlyn T, Graham James A, Learned Susan M, Heidbreder Christian

机构信息

Global Health Economics and Outcomes Research, Indivior Inc, Richmond, VA 23235, USA.

Real-World Evidence and Data Analytics, Pharmerit International, Bethesda, MD 20814, USA.

出版信息

Patient Prefer Adherence. 2019 Jul 2;13:1037-1050. doi: 10.2147/PPA.S202173. eCollection 2019.

Abstract

PURPOSE

RBP-7000 (PERSERIS™) is a once-monthly subcutaneous extended-release risperidone formulation approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. The objective of this study was to describe the long-term impact of RBP-7000 on health-related quality of life (HRQoL), subjective well-being, treatment satisfaction and medication preference in patients with schizophrenia.

PATIENTS AND METHODS

HRQoL was derived from a 52-week multicentre Phase III single-arm open-label outpatient study that assessed the safety and efficacy of RBP-7000 (120 mg) in patients with schizophrenia. HRQoL was measured using the EuroQol EQ-5D-5L and Short-Form Survey SF-36 version 2; well-being using the Subjective Well-being Under Neuroleptic Treatment - Short Version (SWN-S); satisfaction using the Medication Satisfaction Questionnaire and medication preference using the Preference of Medication questionnaire.

RESULTS

Of 482 participants at baseline, 234 remained through the end of study (EOS; week 52). Mean HRQoL and well-being scores remained stable between baseline (EQ-5D-5L index: 0.83; SF-36v2 Physical Component Score: 50; SF-36v2 Mental Component Score: 46; total SWN-S score: 89) and EOS (EQ-5D-5L index: 0.86; SF-36v2 Physical Component Score: 49; SF-36v2 Mental Component Score: 47; total SWN-S score: 90). The proportion of participants reporting satisfaction increased between week 4 (66%) and EOS (81%), with a similar trend for the preference of RBP-7000 over previous treatment (week 4: 66%; EOS: 72%). Sensitivity analyses suggested a minor effect of dropout on characterization of change over time in patient-reported outcomes (PRO) measures.

CONCLUSION

Study participants attained mean HRQoL scores near that of the general US population. Over two-thirds reported high satisfaction with and preference for RBP-7000 across the study period. Additional research is needed to confirm whether these PRO translate into improved outcomes such as adherence and ultimately fewer relapses in patients with schizophrenia.

摘要

目的

RBP - 7000(PERSERIS™)是一种每月皮下注射一次的长效利培酮制剂,已获美国食品药品监督管理局批准用于治疗成人精神分裂症。本研究的目的是描述RBP - 7000对精神分裂症患者健康相关生活质量(HRQoL)、主观幸福感、治疗满意度和药物偏好的长期影响。

患者与方法

HRQoL数据来自一项为期52周的多中心III期单臂开放标签门诊研究,该研究评估了RBP - 7000(120毫克)对精神分裂症患者的安全性和有效性。HRQoL使用欧洲五维度健康量表EQ - 5D - 5L和简明健康调查SF - 36第2版进行测量;幸福感使用抗精神病药物治疗下的主观幸福感简版(SWN - S)进行测量;满意度使用药物满意度问卷进行测量,药物偏好使用药物偏好问卷进行测量。

结果

在基线时的482名参与者中,有234名持续到研究结束(EOS;第52周)。平均HRQoL和幸福感得分在基线(EQ - 5D - 5L指数:0.83;SF - 36v2身体成分得分:50;SF - 36v2精神成分得分:46;SWN - S总分:89)和EOS(EQ - 5D - 5L指数:0.86;SF - 36v2身体成分得分:49;SF - 36v2精神成分得分:47;SWN - S总分:90)之间保持稳定。报告满意的参与者比例在第4周(66%)和EOS(81%)之间有所增加,对RBP - 7000相对于先前治疗的偏好也有类似趋势(第4周:66%;EOS:72%)。敏感性分析表明,失访对患者报告结局(PRO)指标随时间变化特征的影响较小。

结论

研究参与者的平均HRQoL得分接近美国普通人群。在整个研究期间,超过三分之二的参与者报告对RBP - 7000高度满意且有偏好。需要进一步研究以确认这些PRO是否能转化为改善的结局,如依从性提高以及最终精神分裂症患者复发减少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a033/6612993/a926d06b0b80/PPA-13-1037-g0001.jpg

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