Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

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.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

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.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

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.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

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.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

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.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.

Time frame: Baseline, Year 1, 2, 3, 4, 5

Population: FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.

HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.

Time frame: Baseline, Year 1, 2, 3

Population: FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate \[ESR, millimeter per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's general health assessment (recorded on a Visual Analog Scale \[VAS\] of 0 millimeter \[mm\]-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.

Time frame: Baseline

Population: FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.

Time frame: 6 months prior to and 6 months post switching etanercept

Population: FAS population. Here N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure.

HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.

Time frame: Baseline

Population: FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.

Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.

DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.

Time frame: Year 1, 2, 3, 4, 5

Population: FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.

HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score \<=0.5 were considered in remission state.

Time frame: Year 1, 2, 3

Population: FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.

Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.

DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.

Time frame: Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years

Population: FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.