Rheumatoid Arthritis
Conditions
Brief summary
This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Diagnosis of rheumatoid arthritis by a rheumatologist * Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines
Exclusion criteria
* Primary diagnosis of a condition other than rheumatoid arthritis * Current treatment with a biologic in combination without methotrexate * Prior treatment with an experimental agent for rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) | Month 6 | The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6. LDA was defined as a DAS28 score \<3.2. |
| Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6. |
| Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6. |
| Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment | Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 \* √ of TJC) + (0.28 \* √ of SJC) + (0.70 \* ln ESR in mm/h) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \< 2.6. |
| Average Methotrexate Dose of Participants on Biological Combination Treatment | Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | — |
| Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Duration of Treatment | Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Retrospective data was collected for 450 participants of whom 151 received biologic monotherapy, 289 received biologic combination therapy and 10 could not be categorized. Participant flow and baseline characteristics are presented for overall population and endpoints are presented for individual group.
Participants by arm
| Arm | Count |
|---|---|
| Overall Population Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs. | 450 |
| Total | 450 |
Baseline characteristics
| Characteristic | Overall Population |
|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 11.53 |
| Sex: Female, Male Female | 331 Participants |
| Sex: Female, Male Male | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 2 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 |
Outcome results
Primary
Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by \[\*\] the square root \[√\] of TJC) plus (+) (0.28 \* √ of SJC) + (0.70 \* the natural logarithm \[ln\] ESR in millimeters per hour \[mm/h\]) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \<2.6.
Time frame: Month 6
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biologic Monotherapy | Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) | 30.7 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6) | 31.9 percentage of participants |
Comparison: A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.p-value: 0.822295% CI: [-9.5, 12]Pearson's chi-squared
Secondary
Average Methotrexate Dose of Participants on Biological Combination Treatment
Time frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biologic Monotherapy | Average Methotrexate Dose of Participants on Biological Combination Treatment | 17.12 milligrams per week | Standard Deviation 5.64 |
Secondary
Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment
The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6.
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biologic Monotherapy | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Month 3 (n=103,198) | -2.74 units on a scale | Standard Error 0.123 |
| Biologic Monotherapy | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Month 6 (n=105,180) | -3.00 units on a scale | Standard Error 0.119 |
| Biologic Monotherapy | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Last visit (n=115,215) | -3.39 units on a scale | Standard Error 0.124 |
| Biologic Combination | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Month 3 (n=103,198) | -2.84 units on a scale | Standard Error 0.089 |
| Biologic Combination | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Month 6 (n=105,180) | -3.18 units on a scale | Standard Error 0.089 |
| Biologic Combination | Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment | Last visit (n=115,215) | -3.54 units on a scale | Standard Error 0.091 |
Comparison: Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.p-value: 0.519595% CI: [-0.4, 0.2]Mixed Models Analysis
Comparison: Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.p-value: 0.24295% CI: [-0.47, 0.12]Mixed Models Analysis
Comparison: Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.p-value: 0.326495% CI: [-0.45, 0.15]Mixed Models Analysis
Secondary
Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment
The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biologic Monotherapy | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Month 6 (n=107,185) | -7.7 swollen joints | Standard Deviation 5.24 |
| Biologic Monotherapy | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Baseline (n=129,246) | 9.1 swollen joints | Standard Deviation 5.27 |
| Biologic Monotherapy | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Last Visit (n=114,216) | -7.9 swollen joints | Standard Deviation 5.73 |
| Biologic Monotherapy | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Month 3 (n=106,205) | -7.0 swollen joints | Standard Deviation 5.05 |
| Biologic Combination | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Last Visit (n=114,216) | -8.8 swollen joints | Standard Deviation 5.64 |
| Biologic Combination | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Baseline (n=129,246) | 10.0 swollen joints | Standard Deviation 5.64 |
| Biologic Combination | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Month 6 (n=107,185) | -8.3 swollen joints | Standard Deviation 5.57 |
| Biologic Combination | Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment | Change From Baseline at Month 3 (n=106,205) | -7.2 swollen joints | Standard Deviation 5.1 |
Secondary
Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Biologic Monotherapy | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Baseline (n=129,245) | 17.1 tender joints | Standard Deviation 6.98 |
| Biologic Monotherapy | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Month 3 (n=106,203) | -12.5 tender joints | Standard Deviation 7.72 |
| Biologic Monotherapy | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Month 6 (n=107,184) | -14.4 tender joints | Standard Deviation 6.93 |
| Biologic Monotherapy | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Last visit (n=114,215) | -14.9 tender joints | Standard Deviation 8.18 |
| Biologic Combination | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Last visit (n=114,215) | -14.3 tender joints | Standard Deviation 7.28 |
| Biologic Combination | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Baseline (n=129,245) | 16.3 tender joints | Standard Deviation 7.21 |
| Biologic Combination | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Month 6 (n=107,184) | -13.4 tender joints | Standard Deviation 7.51 |
| Biologic Combination | Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Change from baseline at Month 3 (n=106,203) | -12.4 tender joints | Standard Deviation 6.95 |
Secondary
Duration of Treatment
Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.
Time frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biologic Monotherapy | Duration of Treatment | 57.30 months | Standard Deviation 38.227 |
| Biologic Combination | Duration of Treatment | 48.48 months | Standard Deviation 34.619 |
Comparison: Analysis was performed using a general linear model with cohort as a factor.p-value: 0.023795% CI: [-16.44, -1.18]General Linear Model
Secondary
Percentage of Participants by Category of DAS28 Score and Timepoint
The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6.
Time frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: >4 (n=117,219) | 95.7 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: >4 (n=117,222) | 37.1 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: <2.6 (n=117,219) | 2.6 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: ≥2.6 to ≤3.2 (n=117,219) | 0.9 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: >3.2 (n=117,219) | 96.6 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: <2.6 (n=117,222) | 24.1 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: ≥2.6 to ≤3.2 (n=117,222) | 19.8 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: >3.2 (n=117,222) | 56.0 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: <2.6 (n=117,200) | 29.9 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: ≥2.6 to ≤3.2 (n=117,200) | 23.1 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: >3.2 (n=117,200) | 47.0 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: >4 (n=117,200) | 29.9 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: <2.6 (n=136,254) | 44.1 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: ≥2.6 to ≤3.2 (n=136,254) | 18.4 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: >3.2 (n=136,254) | 37.5 percentage of participants |
| Biologic Monotherapy | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: >4 (n=136,254) | 20.6 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: >4 (n=136,254) | 15.4 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: >4 (n=117,219) | 98.2 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: <2.6 (n=117,200) | 30.5 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: >4 (n=117,222) | 32.9 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: <2.6 (n=136,254) | 46.9 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: <2.6 (n=117,219) | 0.5 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: ≥2.6 to ≤3.2 (n=117,200) | 24.5 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: ≥2.6 to ≤3.2 (n=117,219) | 0.5 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: >3.2 (n=136,254) | 29.9 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Baseline: >3.2 (n=117,219) | 99.1 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: >3.2 (n=117,200) | 45.0 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: <2.6 (n=117,222) | 27.9 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Last visit: ≥2.6 to ≤3.2 (n=136,254) | 23.2 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: ≥2.6 to ≤3.2 (n=117,222) | 17.6 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 6: >4 (n=117,200) | 22.5 percentage of participants |
| Biologic Combination | Percentage of Participants by Category of DAS28 Score and Timepoint | Month 3: >3.2 (n=117,222) | 54.5 percentage of participants |
Secondary
Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment
The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 \* √ of TJC) + (0.28 \* √ of SJC) + (0.70 \* ln ESR in mm/h) + (0.014 \* participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score \< 2.6.
Time frame: Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biologic Monotherapy | Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment | Month 3 (n=113,214) | 23.9 percentage of participants |
| Biologic Monotherapy | Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment | Last visit (n=133,243) | 44.4 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment | Month 3 (n=113,214) | 27.6 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment | Last visit (n=133,243) | 46.9 percentage of participants |
Comparison: Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.p-value: 0.472795% CI: [-6.2, 13.6]Pearson's chi-squared
Comparison: Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.p-value: 0.634995% CI: [-8, 13.1]Pearson's chi-squared
Secondary
Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.
The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \<2.6. LDA was defined as a DAS28 score \<3.2.
Time frame: Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Population: Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Biologic Monotherapy | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Month 3 (n=113,214) | 42.5 percentage of participants |
| Biologic Monotherapy | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Month 6 (n=114,191) | 50.0 percentage of participants |
| Biologic Monotherapy | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Last visit (n=133,243) | 57.1 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Last visit (n=133,243) | 67.1 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Month 3 (n=113,214) | 41.6 percentage of participants |
| Biologic Combination | Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment. | Month 6 (n=114,191) | 53.4 percentage of participants |
Comparison: Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.p-value: 0.876995% CI: [-12.1, 10.4]Pearson's chi-squared
Comparison: Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.p-value: 0.564995% CI: [-8.2, 15]Pearson's chi-squared
Comparison: Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.p-value: 0.055695% CI: [-0.3, 20.2]Pearson's chi-squared