Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 6,393
- 主要终点
- Crude Incidence Rate of Malignancy
研究概览
简要总结
This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.
详细描述
patients recruited sequentially as seen in clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rheumatoid arthritis
- •group 1: initiating etanercept as first biologic therapy
- •group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs
排除标准
- •diagnosis of other inflammatory arthritis
研究组 & 干预措施
etanercept
adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
干预措施: etanercept (Drug)
nbDMARD
biologic-naive adult rheumatoid arthritis patients with DAS28 >4.2 treated with non-biologic anti-rheumatic drugs(s).
干预措施: non-biologic anti-rheumatic drugs (Drug)
结局指标
主要结局
Crude Incidence Rate of Malignancy
时间窗: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)
时间窗: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field \[lymphopro\] labeled by BSRBR.
Crude Incidence Rate of Serious Infections
时间窗: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field \[serinf\] labeled by BSRBR.
Crude Incidence Rate of Other Serious Adverse Events
时间窗: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.
Crude Incidence Rate of All-Cause Mortality
时间窗: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years
Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.
次要结局
- Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation(Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years)
- Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline(Baseline)
- Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5(Baseline, Year 1, 2, 3, 4, 5)
- Health Assessment Questionnaire (HAQ) Score at Baseline(Baseline)
- Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)(Year 1, 2, 3, 4, 5)
- Time on Etanercept Therapy(Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years)
- Time to Remission(Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years)
- Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score(Year 1, 2, 3)
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3(Baseline, Year 1, 2, 3)
- Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept(6 months prior to and 6 months post switching etanercept)