Trial Outcomes & Findings for Characterize Patients With Moderately Active Rheumatoid Arthritis (RA) (NCT NCT01557322)

Last Updated: 2013-10-31

Results Overview

ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (\>=) 1 hour; 2) Arthritis/deformity of \>=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: \>=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in \<5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.

Recruitment status

COMPLETED

Target enrollment

1754 participants

Primary outcome timeframe

Baseline

Results posted on

2013-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Overall Study STARTED	211	1543
Overall Study COMPLETED	211	1543
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1543 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	Total n=1754 Participants Total of all reporting groups
Age Continuous	55.3 years n=5 Participants	62.1 years n=7 Participants	61.2 years n=5 Participants
Sex: Female, Male Female	163 Participants n=5 Participants	1098 Participants n=7 Participants	1261 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	445 Participants n=7 Participants	493 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1541 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With American College of Rheumatology (ACR) Criteria Morning Stiffness >1 Hour	194 participants	1316 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Arthritis/Deformity of >=3 Joint Areas	179 participants	1133 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Arthritis/Deformity of Hand/Joint	160 participants	1123 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Symmetry	175 participants	978 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Nodules	91 participants	470 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Rheumatoid Factor Positive	123 participants	927 participants
Number of Participants With American College of Rheumatology (ACR) Criteria Erosions on Hand or Feet X-Ray	116 participants	730 participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable for specified category for each treatment arm, respectively.

Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1540 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Systemic Features Sicca Syndrome (n= 211, 1540)	45 participants	166 participants
Number of Participants With Systemic Features Serosal Involvement (n= 211, 1540)	7 participants	18 participants
Number of Participants With Systemic Features Eye Involvement (n= 211, 1540)	17 participants	93 participants
Number of Participants With Systemic Features Systemic Vasculitis (n= 211, 1540)	6 participants	14 participants
Number of Participants With Systemic Features Nailfold Vasculitis (n= 211, 1540)	3 participants	17 participants
Number of Participants With Systemic Features Pulmonary Fibrosis (n= 211, 1540)	2 participants	37 participants
Number of Participants With Systemic Features Other (n= 211, 1537)	6 participants	34 participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1540 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Prior Joint Replacement or Surgery Total Knee Replacement	31 participants	141 participants
Number of Participants With Prior Joint Replacement or Surgery Total Hip Replacement	29 participants	99 participants
Number of Participants With Prior Joint Replacement or Surgery Total Shoulder Replacement	21 participants	24 participants
Number of Participants With Prior Joint Replacement or Surgery Total Elbow Replacement	14 participants	31 participants
Number of Participants With Prior Joint Replacement or Surgery Wrist/Hand/Ankle/Foot Surgery	56 participants	262 participants
Number of Participants With Prior Joint Replacement or Surgery Neck Surgery	9 participants	9 participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Etanercept n=194 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1441 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Chest X-Ray Prior to New Therapy	183 participants	742 participants

PRIMARY outcome

Timeframe: Baseline

Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.

Outcome measures

Outcome measures
Measure	Etanercept n=208 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1541 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Comorbidities High Blood Pressure (n= 208, 1532)	60 participants	488 participants
Number of Participants With Comorbidities Angina (n= 211, 1536)	5 participants	115 participants
Number of Participants With Comorbidities Heart Attack (n= 210, 1535)	6 participants	73 participants
Number of Participants With Comorbidities Stroke (n= 211, 1538)	3 participants	53 participants
Number of Participants With Comorbidities Epilepsy (n= 211, 1541)	2 participants	19 participants
Number of Participants With Comorbidities Asthma (n= 211, 1539)	24 participants	198 participants
Number of Participants With Comorbidities Chronic Bronchitis/Emphysema (n= 211, 1537)	8 participants	124 participants
Number of Participants With Comorbidities Peptic Ulcer (n= 208, 1537)	11 participants	97 participants
Number of Participants With Comorbidities Liver Disease (n= 211, 1539)	11 participants	26 participants
Number of Participants With Comorbidities Renal Disease (n= 211, 1540)	8 participants	46 participants
Number of Participants With Comorbidities Tuberculosis (n= 207, 1538)	5 participants	34 participants
Number of Participants With Comorbidities Demyelination (n= 210, 1536)	1 participants	7 participants
Number of Participants With Comorbidities Diabetes (n= 211, 1539)	16 participants	93 participants
Number of Participants With Comorbidities Hyperthyroidism (n= 211, 1535)	3 participants	65 participants
Number of Participants With Comorbidities Depression (n= 211, 1539)	40 participants	249 participants
Number of Participants With Comorbidities Cancer (n= 210, 1540)	6 participants	102 participants

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2).

Outcome measures

Outcome measures
Measure	Etanercept n=178 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1462 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Body Mass Index (BMI)	26.6 kg/m^2 Standard Error 0.4	27.2 kg/m^2 Standard Error 0.1

PRIMARY outcome

Timeframe: Baseline

BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).

Outcome measures

Outcome measures
Measure	Etanercept n=199 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1483 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Blood Pressure (BP) Systolic Blood Pressure (n= 199, 1477)	134.3 millimeter of mercury (mmHg) Standard Error 1.4	138.0 millimeter of mercury (mmHg) Standard Error 0.5
Blood Pressure (BP) Diastolic Blood Pressure (n= 199, 1483)	79.4 millimeter of mercury (mmHg) Standard Error 0.8	80.2 millimeter of mercury (mmHg) Standard Error 0.3

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate \[ESR, millimeters per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<2.6: remission, DAS28 \<=3.2: low disease activity, DAS28 \>3.2 to \<=5.1: moderate disease activity, DAS28 \>5.1: progression.

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1543 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 Baseline (n= 211, 1543)	4.6 units on a scale Standard Error 0.03	4.4 units on a scale Standard Error 0.01
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 Change at Month 60 (n= 57, 131)	-1.67 units on a scale Standard Error 0.55	-1.45 units on a scale Standard Error 0.55

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Etanercept n=207 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1526 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Tender Joints Count (TJC) at Month 60 Baseline (n= 207, 1526)	6.1 tender joints Standard Error 0.3	4.8 tender joints Standard Error 0.1
Change From Baseline in Tender Joints Count (TJC) at Month 60 Change at Month 60 (n= 55, 2)	NA tender joints Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.	NA tender joints Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Etanercept n=206 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1526 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Swollen Joints Count (SJC) at Month 60 Baseline (n= 206, 1526)	6.0 swollen joints Standard Error 0.4	3.8 swollen joints Standard Error 0.1
Change From Baseline in Swollen Joints Count (SJC) at Month 60 Change at Month 60 (n= 55, 2)	NA swollen joints Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.	NA swollen joints Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is \<10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	Etanercept n=80 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=431 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 Baseline (n= 80, 431)	28.3 mg/L Standard Error 3.4	23.1 mg/L Standard Error 1.4
Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 Change at Month 60 (n= 15, 0)	NA mg/L Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.	NA mg/L Standard Error NA Result not reported as no participants were evaluable at this time-point.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

Outcome measures

Outcome measures
Measure	Etanercept n=200 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=134 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 Baseline (n= 200, 1344)	24.0 mm/hour Standard Error 1.3	26.3 mm/hour Standard Error 0.5
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 Change at Month 60 (n= 53, 7)	NA mm/hour Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.	NA mm/hour Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Outcome measures

Outcome measures
Measure	Etanercept n=205 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1525 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 Baseline (n= 205, 1525)	49.0 mm Standard Error 1.7	46.7 mm Standard Error 0.5
Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 Change at Month 60 (n= 53, 2)	NA mm Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.	NA mm Standard Error NA Result not reported as there was insufficient data to evaluate the effect in multivariate model.

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Etanercept n=208 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1529 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Duration of Disease (Rheumatoid Arthritis)	14.1 years Standard Error 0.7	10.2 years Standard Error 0.3

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Etanercept n=204 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1501 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Time Since First Rheumatologist Visit	13.1 years Standard Error 0.7	9.7 years Standard Error 0.3

PRIMARY outcome

Timeframe: Baseline

Population: Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.

RA symptoms include joint pain, stiffness, and swelling.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline.

Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1543 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Previous DMARDs: Methotrexate	198 participants	1158 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Methotrexate	65 participants	963 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Azathioprine	7 participants	32 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Cyclophosphamide	0 participants	2 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Cyclosporine	0 participants	27 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Leflunomide	14 participants	158 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Current DMARDs: Sulphasalazine	20 participants	370 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Previous DMARDs: Azathioprine	61 participants	118 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Previous DMARDs: Cyclophosphamide	10 participants	7 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Previous DMARDs: Cyclosporine	40 participants	70 participants
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) Previous DMARDs: Leflunomide	111 participants	209 participants

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Etanercept n=195 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1294 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 Baseline (n= 195, 1294)	1.9 units on a scale Standard Error 0.07	1.5 units on a scale Standard Error 0.04
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 Change at Month 60 (n= 0, 0)	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	Etanercept n=186 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1272 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Baseline: PCS (n= 171, 1202)	27.3 units on a scale Standard Error 0.5	29.8 units on a scale Standard Error 0.2
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Baseline: MCS (n= 171, 1202)	49.1 units on a scale Standard Error 0.6	49.2 units on a scale Standard Error 0.2
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Baseline: Vitality Score (n= 186, 1272)	49.2 units on a scale Standard Error 0.5	49.0 units on a scale Standard Error 0.2
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Change at Month 60: PCS (n= 0, 0)	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Change at Month 60: MCS (n= 0, 0)	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 Change at Month 60: Vitality Score (n= 0, 0)	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.	NA units on a scale Standard Error NA Result not reported as no participants were evaluable at this time-point.

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

Disease worsening (severe RA diagnosis) was defined as DAS28 score \>5.1.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline up to Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

Therapeutic goal achievement was based on physician's discretion.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Population: Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.

Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline

Population: Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.

Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6, 12, 18, 24, 30, 36, 48, 60

Population: Analysis population included all enrolled participants with moderate RA at baseline.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.

Outcome measures

Outcome measures
Measure	Etanercept n=211 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1543 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Adverse Events (AEs) Month 6	22 participants	101 participants
Number of Participants With Adverse Events (AEs) Month 12	10 participants	100 participants
Number of Participants With Adverse Events (AEs) Month 18	12 participants	111 participants
Number of Participants With Adverse Events (AEs) Month 24	10 participants	102 participants
Number of Participants With Adverse Events (AEs) Month 30	12 participants	80 participants
Number of Participants With Adverse Events (AEs) Month 36	6 participants	91 participants
Number of Participants With Adverse Events (AEs) Month 48	3 participants	63 participants
Number of Participants With Adverse Events (AEs) Month 60	7 participants	44 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6, 12, 18, 24, 30, 36, 48, 60

Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.

Outcome measures

Outcome measures
Measure	Etanercept n=191 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1457 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants With Malignancy Solid Tumor: Month 30 (n=127, 1097)	2 participants	5 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 6 (n=191, 1457)	1 participants	1 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 12 (n=172, 1394)	1 participants	1 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 18 (n=146, 1350)	1 participants	0 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 24 (n=141, 1245)	0 participants	0 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 30 (n=127, 1097)	0 participants	3 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 36 (n=128, 1027)	1 participants	1 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 48 (n=114, 815)	1 participants	0 participants
Number of Participants With Malignancy Lymphoproliferative Tumors: Month 60 (n=108, 516)	0 participants	0 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 6 (n=191, 1457)	1 participants	1 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 12 (n=172, 1394)	0 participants	0 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 18 (n=146, 1350)	1 participants	0 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 24 (n=141, 1245)	0 participants	0 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 30 (n=127, 1097)	0 participants	2 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 36 (n=128, 1027)	1 participants	1 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 48 (n=114, 815)	1 participants	0 participants
Number of Participants With Malignancy Hodgkins Lymphoma: Month 60 (n=108, 516)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 6 (n=191, 1457)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 12 (n=172, 1394)	0 participants	1 participants
Number of Participants With Malignancy Myeloma: Month 18 (n=146, 1350)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 24 (n=141, 1245)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 30 (n=127, 1097)	0 participants	1 participants
Number of Participants With Malignancy Myeloma: Month 36 (n=128, 1027)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 48 (n=114, 815)	0 participants	0 participants
Number of Participants With Malignancy Myeloma: Month 60 (n=108, 516)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 6 (n=191, 1457)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 12 (n=172, 1394)	1 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 18 (n=146, 1350)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 24 (n=141, 1245)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 30 (n=127, 1097)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 36 (n=128, 1027)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 48 (n=114, 815)	0 participants	0 participants
Number of Participants With Malignancy Leukaemia: Month 60 (n=108, 516)	0 participants	0 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 6 (n=191, 1457)	0 participants	5 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 12 (n=172, 1394)	0 participants	6 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 18 (n=146, 1350)	0 participants	4 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 24 (n=141, 1245)	1 participants	9 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 30 (n=127, 1097)	0 participants	4 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 36 (n=128, 1027)	0 participants	3 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 48 (n=114, 815)	0 participants	6 participants
Number of Participants With Malignancy Non-Melanoma Skin Cancer: Month 60 (n=108, 516)	0 participants	0 participants
Number of Participants With Malignancy Solid Tumor: Month 6 (n=191, 1457)	2 participants	9 participants
Number of Participants With Malignancy Solid Tumor: Month 12 (n=172, 1394)	0 participants	4 participants
Number of Participants With Malignancy Solid Tumor: Month 18 (n=146, 1350)	0 participants	9 participants
Number of Participants With Malignancy Solid Tumor: Month 24 (n=141, 1245)	0 participants	4 participants
Number of Participants With Malignancy Solid Tumor: Month 36 (n=128, 1027)	0 participants	7 participants
Number of Participants With Malignancy Solid Tumor: Month 48 (n=114, 815)	2 participants	5 participants
Number of Participants With Malignancy Solid Tumor: Month 60 (n=108, 516)	0 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6, 12, 18, 24, 30, 36, 48, 60

Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.

Outcome measures

Outcome measures
Measure	Etanercept n=22 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=111 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 6 (n=22, 101)	1 participants	8 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 12 (n=10, 100)	1 participants	3 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 18 (n=12, 111)	0 participants	3 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 24 (n=10, 102)	2 participants	2 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 30 (n=12, 80)	0 participants	0 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 36 (n=6, 91)	0 participants	2 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 48 (n=3, 63)	0 participants	0 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Death Due to AE: Month 60 (n=7, 44)	1 participants	6 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 6 (n= 18, 85)	16 participants	73 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 12 (n= 8, 81)	6 participants	70 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 18 (n= 11, 77)	10 participants	63 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 24 (n= 5, 70)	5 participants	62 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 30 (n= 8, 64)	6 participants	59 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 36 (n= 4, 69)	4 participants	59 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 48 (n= 1, 38)	1 participants	31 participants
Number of Participants Who Died or Hospitalized Due to Adverse Events Hospitalization Due to AE: Month 60 (n= 4, 24)	4 participants	22 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<2.6: remission, DAS28 \<=3.2: low disease activity, DAS28 \>3.2 to \<=5.1: moderate disease activity, DAS28 \>5.1: progression.

Outcome measures

Outcome measures
Measure	Etanercept n=130 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=437 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6	-0.63 units on a scale Standard Error 0.41	0.08 units on a scale Standard Error 0.39

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	Etanercept n=104 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=676 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6	-0.14 units on a scale Standard Error 0.10	0.08 units on a scale Standard Error 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively.

Outcome measures

Outcome measures
Measure	Etanercept n=104 Participants Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=711 Participants Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6 PCS (n= 87, 633)	0.49 units on a scale Standard Error 1.40	-0.34 units on a scale Standard Error 1.33
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6 MCS (n= 87, 633)	-0.70 units on a scale Standard Error 1.42	-1.21 units on a scale Standard Error 1.35
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6 Vitality Score (n= 104, 711)	1.84 units on a scale Standard Error 1.39	1.70 units on a scale Standard Error 1.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 6

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

Outcome measures

Outcome data not reported

Adverse Events

Etanercept

Serious events: 77 serious events

Other events: 0 other events

Deaths: 0 deaths

nbDMARDs

Serious events: 534 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Etanercept n=211 participants at risk Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.	nbDMARDs n=1543 participants at risk Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
General disorders Pneumonia	1.4% 3/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	4.1% 63/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Septicaemia	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.32% 5/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Bone/Joint Infection	0.95% 2/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.32% 5/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Other Infection	7.6% 16/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	7.1% 109/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Congestive Heart Failure	0.47% 1/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.45% 7/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Myocardial Infarction	1.4% 3/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	1.2% 19/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Other Cardiac Events	0.95% 2/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	2.0% 31/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Central Demyelination	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.06% 1/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Optic Neuritis	0.47% 1/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.00% 0/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Peripheral Neuropathy	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.32% 5/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Other CNS Events	3.8% 8/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	1.9% 30/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Pancytopaenia	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.13% 2/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Leukopaenia	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.13% 2/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Other Dyscrasia	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	1.0% 16/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Lymphoproliferative Tumors	2.4% 5/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.39% 6/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Hodgkin's Lymphoma	1.9% 4/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.26% 4/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Myeloma	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.13% 2/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Leukaemia	0.47% 1/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.00% 0/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Non-Melanoma Skin Cancer	0.47% 1/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	1.9% 30/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Solid Tumor	2.8% 6/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	3.0% 46/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Tuberculosis (TB)	0.00% 0/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.06% 1/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Pregnancy	2.4% 5/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	0.39% 6/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
General disorders Other Serious Events	14.2% 30/211 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.	27.3% 422/1543 This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.