Arthritis, Rheumatoid
Conditions
Brief summary
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
Interventions
1\. To describe the characteristics of patients newly initiated on Inflectra.
Sponsors
Study design
Eligibility
Inclusion criteria
* Be at least 18 years of age * Have been diagnosed with RA by a rheumatologist * Have initiated treatment with Inflectra * Had assessment of effectiveness in patients who have at least one follow up visit.
Exclusion criteria
* No additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation | 6 Months (from the retrospective data collected from the CorEvitas RA registry) | Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (\<=)10. Participants with moderate or high disease activity (CDAI greater than \[\>\]10) at baseline were analyzed for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CDAI at 6 Months After Inflectra Initiation | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) | CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI \<2.8 indicated disease remission, 2.8 to \<10 indicated low disease activity, 10 to \<22 indicated moderate disease activity, and \>=22 indicated high disease activity. |
| Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) | HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 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 ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. |
| Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) | Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). |
| Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation | 6 Months (from the retrospective data collected from the CorEvitas RA registry) | CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved clinical remission had a CDAI score \<=2.8. Participants with low, moderate or high disease activity (CDAI\>2.8) at baseline were analyzed for this outcome measure. |
| Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation | 6 Months (from the retrospective data collected from the CorEvitas RA registry) | mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). |
| Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation | 6 Months (from the retrospective data collected from the CorEvitas RA registry) | mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). |
| Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation | 6 Months (from the retrospective data collected from the CorEvitas RA registry) | mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function). |
| Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation | Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry) | Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
Countries
United States
Participant flow
Recruitment details
Data of participants with Rheumatoid Arthritis (RA) who had initiated Inflectra was retrieved from the CorEvitas RA registry and observed in this retrospective observational study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants (Cohort 1) All participants diagnosed with RA who were Inflectra initiators in real world, who met inclusion criteria, and whose data were observed in this study. | 255 |
| Total | 255 |
Baseline characteristics
| Characteristic | All Participants (Cohort 1) |
|---|---|
| Age, Continuous Cohort 1 | 64.0 Years STANDARD_DEVIATION 12.7 |
| Age, Continuous Cohort 2 | 63.6 Years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Cohort 1 Non-white | 62 Participants |
| Race/Ethnicity, Customized Cohort 1 Not reported | 1 Participants |
| Race/Ethnicity, Customized Cohort 1 White | 192 Participants |
| Race/Ethnicity, Customized Cohort 2 Non-white | 43 Participants |
| Race/Ethnicity, Customized Cohort 2 Not reported | 0 Participants |
| Race/Ethnicity, Customized Cohort 2 White | 133 Participants |
| Sex: Female, Male Cohort 1 Female | 194 Participants |
| Sex: Female, Male Cohort 1 Male | 61 Participants |
| Sex: Female, Male Cohort 2 Female | 138 Participants |
| Sex: Female, Male Cohort 2 Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation
Clinical disease activity index (CDAI) was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 millimeter (mm) visual analogue scale (VAS) where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved LDA had CDAI score less than or equal to (\<=)10. Participants with moderate or high disease activity (CDAI greater than \[\>\]10) at baseline were analyzed for this outcome measure.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with moderate or high disease activity (CDAI\>10) at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Percentage of Participants Who Achieved Low Disease Activity (LDA) at 6 Months After Inflectra Initiation | 32.9 Percentage of participants |
Change From Baseline in CDAI at 6 Months After Inflectra Initiation
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). CDAI total score = 0 to 76, higher scores=greater affection due to disease activity. CDAI \<2.8 indicated disease remission, 2.8 to \<10 indicated low disease activity, 10 to \<22 indicated moderate disease activity, and \>=22 indicated high disease activity.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Change From Baseline in CDAI at 6 Months After Inflectra Initiation | -1.8 Units on scale | Standard Deviation 10 |
Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation
HAQ: participant-reported questionnaire for the assessment of rheumatoid arthritis. It comprised of 20 questions in 8 categories of activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and activities over past week. Each activity was assessed on a 4-point Likert scale from 0 to 3, where 0 = without difficulty, 1 = with some difficulty, 2 = with much difficulty, and 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 ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months After Inflectra Initiation | -0.0 Units on scale | Standard Deviation 0.4 |
Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation
Participant fatigue was measured on a VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Change From Baseline in Participant Fatigue Assessment at 6 Months After Inflectra Initiation | -1.4 Millimeter | Standard Deviation 24.4 |
Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation
Participant pain was measured on a VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
Time frame: Baseline, 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Change From Baseline in Participant Pain Assessment at 6 Months After Inflectra Initiation | -0.5 Millimeter | Standard Deviation 22.4 |
Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation
CDAI was the numerical sum of 4 outcome parameters: tender and swollen joint count based on a 28-joint assessment, participant global assessment and physician global assessment assessed on 0 to 10 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). Total score for CDAI ranged from 0 to 76 with higher score indicating greater disease activity. Participants who achieved clinical remission had a CDAI score \<=2.8. Participants with low, moderate or high disease activity (CDAI\>2.8) at baseline were analyzed for this outcome measure.
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with moderate or high disease activity (CDAI\>2.8) at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Percentage of Participants Who Achieved Clinical Remission at 6 Months After Inflectra Initiation | 13.7 Percentage of Participants |
Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation
mACR20 response: \>= 20% improvement in tender and swollen joint count and 20% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Percentage of Participants With a Modified American College of Rheumatology 20 Percent (%) (mACR20) Response at 6 Months After Inflectra Initiation | 12.6 Percentage of participants |
Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation
mACR50 response: \>= 50% improvement in tender and swollen joint count and 50% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Percentage of Participants With mACR50 at 6 Months After Inflectra Initiation | 8.4 Percentage of participants |
Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation
mACR70 response: \>= 70% improvement in tender and swollen joint count and 70% improvement in two of the following four criteria: 1) participant assessment of pain (scored from 0 mm to 100 mm, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Time frame: 6 Months (from the retrospective data collected from the CorEvitas RA registry)
Population: All eligible participants who had CDAI available at baseline and at 6-months follow-up visit and CDAI measured at the 6-month follow-up visit. Here Number of Participants Analyzed signifies number of participants with complete information for calculation of mACR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With 6-Months Follow-up (Cohort 2) | Percentage of Participants With mACR70 at 6 Months After Inflectra Initiation | 4.2 Percentage of participants |