接受Janus激酶抑制剂或bDMARDs治疗的类风湿关节炎患者发生恶性肿瘤的比较风险:来自德国RABBIT登记的观察性数据

IF 20.3 1区 医学 Q1 RHEUMATOLOGY
Martin Schaefer, Alina Purschke, Vera Zietemann, Tatjana Rudi, Yvette Meissner, Adrian Richter, Sylvia Berger, Karin Rockwitz, Klaus Krüger, Karl Matthias Schneider, Anne C Regierer, Anja Strangfeld
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引用次数: 0

摘要

目的:评估类风湿关节炎患者和患者亚组中Janus激酶抑制剂(JAKis)与生物疾病改善抗风湿药物(bDMARDs)对恶性肿瘤(不包括非黑色素瘤皮肤癌)发生风险的影响。方法:分析2017年1月至2020年12月期间在RABBIT(德国注册机构,用于长期观察成年类风湿性关节炎患者使用生物制剂和靶向改善疾病抗风湿药物治疗)中开始的疾病改善抗风湿药物(DMARD)治疗的发作情况,并随访至2024年6月。计算每1000例患者年95% ci的发病率(IRs),并通过反概率加权调整Cox模型以风险比(hr)估计恶性肿瘤的发生率。结果:在2285例JAKi和4259例bDMARD治疗中,分别发生88例和135例恶性肿瘤。JAKi治疗以巴西替尼和托法替尼为主,而大多数bDMARD治疗包括肿瘤坏死因子抑制剂。JAKi组ir为11.6 (95% CI: 9.3, 14.3), bdmard组ir为8.9 (95% CI: 7.4, 10.5)。JAKis与bDMARDs的校正HR为1.40 (95% CI: 1.09, 1.80)。与bDMARD治疗相比,JAKi治疗的恶性肿瘤风险增加仅在治疗持续时间超过16个月时才会观察到。在一些亚组患者中,风险更高,包括那些开始治疗年龄≥60岁的患者,既往接受≥3次常规合成DMARD治疗的患者,以及疾病活动性高的患者。结论:在这项德国观察性队列研究中,观察到JAKi与bDMARD治疗的恶性肿瘤风险总体上略有增加,在某些亚组患者中风险更明显。观察到的风险应该仔细地与已知的与疾病控制不足相关的恶性肿瘤风险相平衡。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative risk of incident malignancies in rheumatoid arthritis patients treated with Janus kinase inhibitors or bDMARDs: observational data from the German RABBIT register.

Objectives: To estimate the effects of Janus kinase inhibitors (JAKis) vs biologic disease-modifying antirheumatic drugs (bDMARDs) on the risk of incident malignancies (excluding nonmelanoma skin cancer) in patients and patient subgroups with rheumatoid arthritis.

Methods: Episodes of disease-modifying antirheumatic drug (DMARD) treatment initiated between January 2017 and December 2020 and followed up to June 2024 in RABBIT, the German register for the long-term observation of therapy with biologics and targeted disease-modifying antirheumatic drugs in adult patients with rheumatoid arthritis, were analysed. Incidence rates (IRs) per 1000 patient-years with 95% CIs were calculated, and incident malignancy risk was estimated as hazard ratios (HRs) by inverse probability weighted adjusted Cox models.

Results: Among 2285 JAKi and 4259 bDMARD treatment episodes, 88 and 135 malignancies occurred, respectively. JAKi treatments were dominated by baricitinib and tofacitinib, while most bDMARD treatments comprised tumour necrosis factor inhibitors. IRs were 11.6 (95% CI: 9.3, 14.3) in JAKi- and 8.9 (95% CI: 7.4, 10.5) in bDMARD-treated groups. The adjusted HR comparing JAKis with bDMARDs was 1.40 (95% CI: 1.09, 1.80). An increase in the malignancy risk for JAKi vs bDMARD treatment could only be observed in treatment episodes lasting longer than 16 months. The risk appeared higher in some subgroups of patients, including those who started treatment aged ≥60 years, patients with ≥3 prior conventional synthetic DMARD treatments, and patients with high disease activity.

Conclusions: In this German observational cohort study, an overall small increase in malignancy risk for JAKi vs bDMARD treatment was observed, with more pronounced risks in some subgroups of patients. The observed risk should be carefully counterbalanced to the known malignancy risk associated with insufficient disease control.

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来源期刊
Annals of the Rheumatic Diseases
Annals of the Rheumatic Diseases 医学-风湿病学
CiteScore
35.00
自引率
9.90%
发文量
3728
审稿时长
1.4 months
期刊介绍: Annals of the Rheumatic Diseases (ARD) is an international peer-reviewed journal covering all aspects of rheumatology, which includes the full spectrum of musculoskeletal conditions, arthritic disease, and connective tissue disorders. ARD publishes basic, clinical, and translational scientific research, including the most important recommendations for the management of various conditions.
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