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在Corrona银屑病注册研究中接受阿普米拉斯治疗的银屑病患者的特征。

Characteristics of Patients with Psoriasis Treated with Apremilast in the Corrona Psoriasis Registry.

作者信息

Gottlieb Alice B, Merola Joseph F, Cirulli Joshua, Williams Catherine C, Linowski Gregory J, Paris Maria, Litman Heather J, Guo Ning, Emeanuru Kelechi, McLean Robert R, Cronin Angel, Strober Bruce

机构信息

Department of Dermatology, Mount Sinai Beth Israel Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

出版信息

Dermatol Ther (Heidelb). 2021 Feb;11(1):253-263. doi: 10.1007/s13555-020-00479-4. Epub 2021 Jan 21.

Abstract

INTRODUCTION

Data on the characteristics of apremilast patients in real-world settings are limited. We assessed the demographics and disease characteristics of apremilast-treated patients in the Corrona Psoriasis Registry overall and by treatment history.

METHODS

The Corrona Psoriasis Registry is a large, independent, prospective, observational registry of adult patients (age ≥ 18 years) who initiate an eligible systemic medication for treatment of psoriasis at or after enrollment (incident users) or within 12 months before enrollment (prevalent users). The current analyses included psoriasis patients enrolled in the Corrona Psoriasis Registry between April 1, 2015, and January 7, 2018. Patients were adults (age ≥ 18 years) with psoriasis who were enrolled between April 1, 2015, and January 7, 2018 and initiated apremilast at the time of registry enrollment or a subsequent visit (incident users) or within the 12 months prior to registry enrollment (prevalent users). Patient characteristics were evaluated descriptively at the index date, defined as the enrollment date for prevalent users and the visit when apremilast was initiated for incident users.

RESULTS

Among 660 patients who initiated apremilast at registry enrollment or a visit thereafter, psoriatic arthritis, hypertension, and hyperlipidemia were common. There were more systemic-experienced (61.4%) versus systemic-naive (38.6%) patients; 43.8% had prior biologic exposure. Most patients were not receiving concomitant systemic treatment (70.2%); 27.4% were receiving concomitant biologic therapy. Most patients had mild or moderate disease (psoriasis-involved body surface area ≤ 10% [76.0%], Investigator Global Assessment ≤ 3 [88.3%], Psoriasis Area and Severity Index ≤ 10 [84.5%]). Dermatologist-reported psoriatic arthritis was present in 47.0% of patients; 33.9% of patients had a Psoriasis Epidemiology Screening Tool score  of ≥ 3, suggestive of psoriatic arthritis. Systemic-experienced apremilast patients had higher rates of obesity and comorbidities and experienced a greater impact on quality of life (mean Dermatology Life Quality Index, 7.3 vs. 6.5) versus systemic-naive patients.

CONCLUSION

In this real-world observational study of apremilast users in the Corrona Psoriasis Registry, most patients had less-severe disease and higher rates of prior exposure to biologic treatments compared with patients with moderate-to-severe psoriasis enrolled in phase 3 clinical studies.

摘要

引言

关于阿普米司特在真实世界中患者特征的数据有限。我们评估了科罗娜银屑病登记处中接受阿普米司特治疗患者的人口统计学和疾病特征,整体情况以及按治疗史进行了评估。

方法

科罗娜银屑病登记处是一个大型、独立、前瞻性的观察性登记处,登记对象为成年患者(年龄≥18岁),这些患者在入组时或之后开始使用符合条件的系统性药物治疗银屑病(新发病例使用者),或在入组前12个月内开始使用(现患病例使用者)。当前分析纳入了2015年4月1日至2018年1月7日期间登记在科罗娜银屑病登记处的银屑病患者。患者为年龄≥18岁的银屑病成年患者,于2015年4月1日至2018年1月7日期间入组,并在登记入组时或随后的就诊时开始使用阿普米司特(新发病例使用者),或在登记入组前12个月内开始使用(现患病例使用者)。在索引日期对患者特征进行描述性评估,索引日期对现患病例使用者定义为入组日期,对新发病例使用者定义为开始使用阿普米司特的就诊日期。

结果

在660例在登记入组时或之后就诊时开始使用阿普米司特的患者中,银屑病关节炎、高血压和高脂血症很常见。有系统性治疗经验的患者(61.4%)多于无系统性治疗经验的患者(38.6%);43.8%的患者曾接受过生物制剂治疗。大多数患者未接受联合系统性治疗(70.2%);27.4%的患者正在接受联合生物治疗。大多数患者患有轻度或中度疾病(银屑病累及体表面积≤10%[76.0%],研究者整体评估≤3[88.3%],银屑病面积和严重程度指数≤10[84.5%])。皮肤科医生报告47.0%的患者存在银屑病关节炎;33.9%的患者银屑病流行病学筛查工具评分≥3,提示银屑病关节炎。与无系统性治疗经验的阿普米司特患者相比,有系统性治疗经验的阿普米司特患者肥胖和合并症发生率更高,对生活质量的影响更大(平均皮肤病生活质量指数,7.3对6.5)。

结论

在这项针对科罗娜银屑病登记处阿普米司特使用者的真实世界观察性研究中,与纳入3期临床研究的中度至重度银屑病患者相比,大多数患者疾病较轻,且既往接受生物治疗的比例更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c1a1/7858993/857f9444a532/13555_2020_479_Fig1_HTML.jpg

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