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生物制剂治疗实体恶性肿瘤后的结果:来自 Corrona 注册研究。

Therapy with Biologic Agents After Diagnosis of Solid Malignancies: Results from the Corrona Registry.

机构信息

From Columbia University, New York, New York; Corrona LLC, Waltham, Massachusetts; DOCS Global Inc., North Wales, Pennsylvania; University of Massachusetts Medical School, Worcester, Massachusetts; Amgen Inc., Thousand Oaks, California, USA.

D.A. Pappas, MD, MPH, Columbia University, and Corrona LLC; S. Rebello, MPH, Corrona LLC; M. Liu, PhD, Corrona LLC; J. Schenfeld, MPH, DOCS Global Inc.; Y.F. Li, MD, MPH, University of Massachusetts Medical School; D.H. Collier, MD, Amgen Inc.; N.A. Accortt, PhD, Amgen Inc.

出版信息

J Rheumatol. 2019 Nov;46(11):1438-1444. doi: 10.3899/jrheum.171457. Epub 2019 Apr 1.

DOI:10.3899/jrheum.171457
PMID:30936285
Abstract

OBJECTIVE

Guidelines suggest that rheumatoid arthritis (RA) patients with previously treated solid malignancy may be treated as patients without such history. The recommendation is based on limited evidence, and rheumatologists and patients are frequently hesitant to start or continue biologic therapy after a cancer diagnosis. The objective of this study was to describe biologic use in real-world patients with RA following a malignancy diagnosis.

METHODS

RA patients enrolled in the Corrona registry and diagnosed with solid malignancy with at least 1 followup visit within 12 months after diagnosis were included in this analysis. The proportion of patients continuing or initiating biological/targeted synthetic disease-modifying antirheumatic drug (bDMARD/tsDMARD) after diagnosis was estimated. Median time to initiation of bDMARD/tsDMARD after diagnosis was calculated using the Kaplan-Meier method and the proportion initiating biologic treatment in 6-month time intervals was estimated using the life-table method.

RESULTS

There were 880 patients who met inclusion criteria with 2585 person-years total followup time postdiagnosis. Of those, 367 (41.7%) were treated with bDMARD/tsDMARD within 12 months preceding malignancy, of whom 270 (30.7%) were taking such agents at first postdiagnosis visit. Forty-four (5%) switched biologic agents within 36 months and an additional 90 patients (10.2%) started a biologic. The majority of bDMARD/tsDMARD initiations during followup was a tumor necrosis factor inhibitor (TNFi; 53.5%).

CONCLUSION

In real-world practice, nearly one-third of RA patients with a cancer diagnosis were treated with systemic therapy in the immediate visit after malignancy diagnosis and a considerable percentage of malignancy survivors initiated biologic therapy within 3 years. The majority of bDMARD/tsDMARD initiations post-malignancy diagnosis was a TNFi.

摘要

目的

指南建议,既往患有实体瘤的类风湿关节炎(RA)患者可按无此类病史患者进行治疗。这一建议基于有限的证据,且在癌症诊断后,风湿病医生和患者常常不愿开始或继续使用生物制剂治疗。本研究旨在描述癌症诊断后 RA 患者的真实世界中生物制剂的使用情况。

方法

本分析纳入了 Corrona 登记研究中的 RA 患者,这些患者被诊断为患有实体瘤,且在诊断后 12 个月内至少有 1 次随访。估计了诊断后继续或开始使用生物/靶向合成疾病修饰抗风湿药物(bDMARD/tsDMARD)的患者比例。采用 Kaplan-Meier 法计算诊断后开始 bDMARD/tsDMARD 的中位时间,并采用寿命表法估计 6 个月时间间隔内开始生物治疗的比例。

结果

共有 880 例患者符合纳入标准,总随访时间为 2585 人年。其中,367 例(41.7%)在恶性肿瘤前 12 个月内接受 bDMARD/tsDMARD 治疗,其中 270 例(30.7%)在首次诊断后就诊时接受此类药物治疗。44 例(5%)在 36 个月内更换了生物制剂,另外 90 例(10.2%)开始使用生物制剂。在随访期间,大多数 bDMARD/tsDMARD 的起始治疗药物为肿瘤坏死因子抑制剂(TNFi;53.5%)。

结论

在真实世界实践中,近三分之一的癌症诊断 RA 患者在恶性肿瘤诊断后的首次就诊中接受了全身治疗,相当一部分癌症幸存者在 3 年内开始使用生物制剂治疗。恶性肿瘤诊断后开始 bDMARD/tsDMARD 治疗的主要药物为 TNFi。

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