tocilizumab治疗类风湿性关节炎患者的癌症风险：来自法国国家注册REGATE的数据

IF 3.8 3区医学 Q1 RHEUMATOLOGY

Joint Bone Spine Pub Date : 2025-04-04 DOI:10.1016/j.jbspin.2025.105900

Jacques Morel , Amélie Wetzman , Daniel Wendling , Martin Soubrier , Sylvie Hoang , Daniel Briançon , Olivier Roth , Philippe Goupille , Jacques-Eric Gottenberg , Xavier Mariette , Cédric Lukas , On behalf of the French Society of Rheumatology, the investigators participating in REGATE registry

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引用次数: 0

摘要

目的：我们的研究旨在评估接受tocilizumab （TCZ）治疗的类风湿性关节炎（RA）患者的癌症发病率和危险因素，并在法国注册中心（REGATE）进行了5年的随访。REGATE注册是一项法国前瞻性队列研究，旨在调查TCZ治疗RA的安全性（注册号：910346）。在2011年至2016年期间，使用e-CRF收集数据，并专门向REGATE报告恶性肿瘤的参与中心分发问卷。我们主要关注实体癌、血液恶性肿瘤和非黑色素瘤皮肤癌（NMSC）。为了确定与癌症相关的潜在危险因素，我们使用Cox比例风险模型进行了单因素分析和多因素分析。结果：我们的研究纳入了1496例RA患者，他们接受TCZ治疗的平均持续时间为32.0（±22.0）个月，平均随访时间为47（±15.2）个月，导致总暴露量为3990.9患者年（PY）。在这些患者中，63例（4.2%）在随访期间被诊断出总共75种癌症（35例实体肿瘤，11例血液恶性肿瘤，3例黑色素瘤和26例NMSC）。除NMSC外的总体癌症发病率为7.5 /1000 PY（暴露时间）。我们的多因素分析显示，高龄（HR=1.05[1.02-1.08]）、吸烟（HR=2.65[1.27-5.53]）和男性（HR= 2.38[1,18-4,80]）是实体癌的独立危险因素。年龄和吸烟与血液恶性肿瘤的高风险相关。结论：除了在一般人群中已知的危险因素外，我们没有发现在TCZ下RA患者的癌症危险因素。

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Risk of cancer in patients with rheumatoid arthritis under tocilizumab: Data from the French national registry REGATE

Objective

Our study aimed to estimate the incidence and risk factors of cancer among rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and followed for five years in the French registry (REGATE).

Method

The REGATE registry is a French prospective cohort study investigating the safety of TCZ in RA (registration n^o: 910346). Data were collected using an e-CRF between 2011 and 2016 and with a questionnaire specifically distributed to participating centers that reported malignancies in REGATE. We mainly focused on solid cancers, hematological malignancies, and non-melanoma skin cancers (NMSC). To identify potential risk factors associated with cancer, we performed a univariate analysis and a multivariate analysis using Cox proportional hazards models.

Results

Our study included 1496 patients with RA who were treated with TCZ for a mean duration of 32.0 (±22.0) months and followed for an average of 47 (±15.2) months, resulting in a total exposure of 3990.9 patient-years (PY). Of these patients, 63 (4.2%) were diagnosed with a total of 75 cancers during the follow-up period (35 solid neoplasms, 11 hematological malignancies, 3 melanomas, and 26 NMSC). The overall incidence of cancer excluding NMSC was 7.5/1000 PY (exposure time). Our multivariate analysis revealed that high age (HR = 1.05 [1.02–1.08]), current smoker (HR = 2.65 [1.27–5.53]) and male 2.38 [1,18–4,80]) were independent risk factors for solid cancers. Age and active smoking were associated with higher risk of hematological malignancies.

Conclusion

We found no additional risk factors of cancer for RA patients under TCZ, beyond those already known in the general population.

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来源期刊

Joint Bone Spine 医学-风湿病学

CiteScore

4.50

自引率

11.90%

发文量

184

审稿时长

25 days

期刊介绍： Bimonthly e-only international journal, Joint Bone Spine publishes in English original research articles and all the latest advances that deal with disorders affecting the joints, bones, and spine and, more generally, the entire field of rheumatology. All submitted manuscripts to the journal are subjected to rigorous peer review by international experts: under no circumstances does the journal guarantee publication before the editorial board makes its final decision. (Surgical techniques and work focusing specifically on orthopedic surgery are not within the scope of the journal.)Joint Bone Spine is indexed in the main international databases and is accessible worldwide through the ScienceDirect and ClinicalKey platforms.