Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, etanercept, adalimumab, infliximab, anti-drug antibody, immunogenicity, drug concentration
Brief summary
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
Detailed description
cross-sectional Population will be selected through convenience sampling. Patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. A maximum of 200 patients per treatment will be enrolled.
Interventions
OTHERno intervention
Sponsors
Pfizer
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria 3. Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.
Exclusion criteria
1. Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months. 2. Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer. 3. Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). | 1 day | Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL. |
| Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | 1 Day | Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined. |
| The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 Day | The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI \> 2.8 and ≤ 10; Moderate Disease Activity CDAI \> 10 and ≤ 22; High Disease Activity CDAI \> 22. |
| The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI \> 3.3 and ≤ 11; Moderate Disease Activity SDAI \> 11 and ≤ 26; High Disease Activity SDAI \> 26. |
| Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. |
| Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined). | 1 day | Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count \[DAS28\] Erythrocyte sedimentation rate \[ESR\] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined). |
| Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst). |
| Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | HAQ DI (\<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. |
| Correlation of Antidrug Antibody Titers With Efficacy Measures. | 1 day | Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient. |
| Correlation of Antidrug Antibody Titers With Trough Drug Concentration. | 1 day | Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient. |
| Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | 1 day | The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment. |
Countries
Argentina, Australia, Bulgaria, Turkey (Türkiye), United States
Participant flow
Recruitment details
This is a multicenter, non-interventional (NI) study conducted to evaluate data collected from a cross sectional population of participants with rheumatoid arthritis (RA) who received treatment with etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
Pre-assignment details
Participants treated with one of the three targeted therapies were enrolled using interactive response technology to assure data for approximately 200 participants were included for each RA treatment.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 200 |
| Adalimumab Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 199 |
| Infliximab Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit. | 196 |
| Total | 595 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Incorrect diagnosis of RA | 0 | 0 | 1 |
| Overall Study | Received treatment for >24 months | 2 | 0 | 6 |
| Overall Study | Received treatment for < 6 months | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Etanercept | Adalimumab | Infliximab | Total |
|---|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 13.37 | 54.3 years STANDARD_DEVIATION 12.95 | 60.7 years STANDARD_DEVIATION 13.01 | 57.1 years STANDARD_DEVIATION 13.36 |
| Sex: Female, Male Female | 155 Participants | 162 Participants | 157 Participants | 474 Participants |
| Sex: Female, Male Male | 45 Participants | 37 Participants | 39 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 200 | 4 / 199 | 11 / 196 |
| serious Total, serious adverse events | 1 / 200 | 0 / 199 | 1 / 196 |
Outcome results
Primary
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). | 0 Percentage of participants |
| Adalimumab/ Infliximab | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). | 24.4 Percentage of participants |
Comparison: This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.p-value: <0.0001Fisher Exact
Secondary
Correlation of Antidrug Antibody Titers With Efficacy Measures.
Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab/ Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | CDAI | 0.07447 Correlation coefficient |
| Adalimumab/ Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | DAS28-ESR | 0.12179 Correlation coefficient |
| Adalimumab/ Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | SDAI | 0.08970 Correlation coefficient |
| Adalimumab/ Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | DAS28-CRP | 0.12710 Correlation coefficient |
| Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | DAS28-CRP | 0.08366 Correlation coefficient |
| Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | CDAI | 0.05256 Correlation coefficient |
| Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | SDAI | 0.06806 Correlation coefficient |
| Infliximab | Correlation of Antidrug Antibody Titers With Efficacy Measures. | DAS28-ESR | 0.08950 Correlation coefficient |
Secondary
Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab/ Infliximab | Correlation of Antidrug Antibody Titers With Trough Drug Concentration. | -0.69017 Correlation coefficient |
| Infliximab | Correlation of Antidrug Antibody Titers With Trough Drug Concentration. | -0.60542 Correlation coefficient |
Secondary
Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA Units on a scale | — |
| Etanercept | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 2.9 Units on a scale | Standard Deviation 1.18 |
| Adalimumab/ Infliximab | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 3.4 Units on a scale | Standard Deviation 1.22 |
| Adalimumab/ Infliximab | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 3.1 Units on a scale | Standard Deviation 1.36 |
| Infliximab | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 3.7 Units on a scale | Standard Deviation 1.3 |
| Infliximab | Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 3.4 Units on a scale | Standard Deviation 1.26 |
Secondary
Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA Units on a scale | — |
| Etanercept | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 2.5 Units on a scale | Standard Deviation 1.2 |
| Adalimumab/ Infliximab | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 3.1 Units on a scale | Standard Deviation 1.22 |
| Adalimumab/ Infliximab | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 2.8 Units on a scale | Standard Deviation 1.43 |
| Infliximab | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 3.5 Units on a scale | Standard Deviation 1.33 |
| Infliximab | Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 3.1 Units on a scale | Standard Deviation 1.31 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA Units on a scale | — |
| Etanercept | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 0.8 Units on a scale | Standard Deviation 0.68 |
| Adalimumab/ Infliximab | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 1.0 Units on a scale | Standard Deviation 0.75 |
| Adalimumab/ Infliximab | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 0.9 Units on a scale | Standard Deviation 0.7 |
| Infliximab | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 1.2 Units on a scale | Standard Deviation 0.69 |
| Infliximab | Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 1.0 Units on a scale | Standard Deviation 0.63 |
Secondary
Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
HAQ DI (\<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA+ | NA percentage of participants |
| Etanercept | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA- | 42.5 percentage of participants |
| Adalimumab/ Infliximab | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA+ | 30.6 percentage of participants |
| Adalimumab/ Infliximab | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA- | 36.5 percentage of participants |
| Infliximab | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA- | 26.1 percentage of participants |
| Infliximab | Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | % AA+ | 20.6 percentage of participants |
Secondary
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
Time frame: 1 Day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | 0 Percentage of participants |
| Adalimumab/ Infliximab | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | 31.2 Percentage of participants |
| Infliximab | Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab. | 17.4 Percentage of participants |
Secondary
Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).
Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count \[DAS28\] Erythrocyte sedimentation rate \[ESR\] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined). | 56.4 percentage of participants |
| Adalimumab/ Infliximab | Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined). | 62.0 percentage of participants |
Secondary
Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA µg/mL | — |
| Etanercept | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 1.8 µg/mL | Standard Deviation 1.03 |
| Adalimumab/ Infliximab | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 1.5 µg/mL | Standard Deviation 2.24 |
| Adalimumab/ Infliximab | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 7.7 µg/mL | Standard Deviation 4.72 |
| Infliximab | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 0.2 µg/mL | Standard Deviation 0.9 |
| Infliximab | Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 9.8 µg/mL | Standard Deviation 15.25 |
Secondary
The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI \> 2.8 and ≤ 10; Moderate Disease Activity CDAI \> 10 and ≤ 22; High Disease Activity CDAI \> 22.
Time frame: 1 Day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA units on a scale | — |
| Etanercept | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 12.6 units on a scale | Standard Deviation 10.62 |
| Adalimumab/ Infliximab | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 17.3 units on a scale | Standard Deviation 13.56 |
| Adalimumab/ Infliximab | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 16.3 units on a scale | Standard Deviation 14.83 |
| Infliximab | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 21.7 units on a scale | Standard Deviation 16.12 |
| Infliximab | The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 18.5 units on a scale | Standard Deviation 13.84 |
Secondary
The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI \> 3.3 and ≤ 11; Moderate Disease Activity SDAI \> 11 and ≤ 26; High Disease Activity SDAI \> 26.
Time frame: 1 day
Population: FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | NA units on a scale | — |
| Etanercept | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 13.5 units on a scale | Standard Deviation 10.95 |
| Adalimumab/ Infliximab | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 18.5 units on a scale | Standard Deviation 14.52 |
| Adalimumab/ Infliximab | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 16.8 units on a scale | Standard Deviation 14.91 |
| Infliximab | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA+ | 23.1 units on a scale | Standard Deviation 16.33 |
| Infliximab | The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative. | AA- | 19.2 units on a scale | Standard Deviation 13.89 |