| 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. | 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. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission. | Pearson's chi-squared | | 0.8222 | | Treatment Difference | 1.2 | | | 2-Sided | 95 | -9.5 | 12.0 | | | | No | Superiority or Other | | |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | months | | Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| Secondary | Average Methotrexate Dose of Participants on Biological Combination Treatment | | Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose. | Posted | | Mean | Standard Deviation | milligrams per week | | Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | tender joints | | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | swollen joints | | Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) | | | | ID | Title | Description |
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| OG000 | Biologic Monotherapy | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines. | | OG001 | Biologic Combination | Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines. |
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