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
Overview
- Phase
- Not Applicable
- Intervention
- etanercept
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Pfizer
- Enrollment
- 6393
- Primary Endpoint
- Crude Incidence Rate of Malignancy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
patients recruited sequentially as seen in clinical practice
Investigators
Eligibility Criteria
Inclusion Criteria
- •rheumatoid arthritis
- •group 1: initiating etanercept as first biologic therapy
- •group 2: DAS28\<4.2, biologic naive and treated with non-biologic DMARDs
Exclusion Criteria
- •diagnosis of other inflammatory arthritis
Arms & Interventions
etanercept
adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
Intervention: etanercept
nbDMARD
biologic-naive adult rheumatoid arthritis patients with DAS28 \>4.2 treated with non-biologic anti-rheumatic drugs(s).
Intervention: non-biologic anti-rheumatic drugs
Outcomes
Primary Outcomes
Crude Incidence Rate of Malignancy
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)