Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs), especially abatacept which compared to Tumor Necrosis Factor α (TNFα) inhibitors has distinct mechanism of action. Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and the Fc region of human immunoglobulin gamma-1 (IgG1). This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86.
Recently, the investigator's study found in a US cohort of 64,000 patients with Rheumatoid Arthritis (RA) a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs (article in press). These results were in accordance with another prospective cohort study of the public health care system in Sweden, showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors. As these results warrant replication, the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer, including breast, lung, lymphoma, cervical, melanoma and NMSC, compared to other bDMARDs.
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Toulouse、法国、31059
- 招聘中
- UHToulouse
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接触:
- François MD MONTASTRUC, PhD
- 电话号码:+33 5 61 14 59 60
- 邮箱:francois.montastruc@univ-tlse3.fr
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接触:
- Isabelle OLIVIER, PhD
- 电话号码:+33 561777051
- 邮箱:olivier.i@chu-toulouse.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- case reported in the World Health Organization (WHO) database of individual safety case report to 11/20/2018
- Patient treated with at least one bDMARD prescriptions
- adverse events reported were including the MedDRA terms
Exclusion Criteria:
- Chronology not compatible
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:追溯
队列和干预
团体/队列 |
干预/治疗 |
---|---|
abatacept
patients with abatacept prescription
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Case report of cancer overall
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others bDMARDs
patients with at least one bDMARD prescriptions
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Case report of cancer overall
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Risk of reporting cancer overall specific cancers
大体时间:Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Estimate statistically the risk of reporting cancer overall and specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis
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Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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Risk of reporting specific cancers
大体时间:Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
|
Estimate statistically the risk of specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis
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Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
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合作者和调查者
调查人员
- 研究主任:François MONTASTRUC, PhD MD、University Hospital, Toulouse
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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