To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.

Study Overview
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Brief Summary
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To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.

Official Title
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Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: patterns of use of combination therapy and monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib Exclusion Criteria: Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses Patients using combination therapy with a cDMARD other than MTX will be excluded Patients using combination therapy of MTX and another cDMARD will be excluded
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All TNFi initiations<br> | Other: patterns of use of combination therapy and monotherapy<br> <br> |
| TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators<br> | Other: patterns of use of combination therapy and monotherapy<br> <br> |
| RA patient in Corrona with initiation Tofacitinib during follow-up in Corron<br> | Other: patterns of use of combination therapy and monotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on tofacitinib monotherapy vs tofacitinib with MTX | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on TNFi monotherapy vs TNFi combination with MTX | 6 months | 
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi combination with MTX | 6 months | 
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi monotherapy | 6 months | 
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs TNFi combination with MTX | 6 months | 
| Achievement of LDA or remission based on CDAI score | Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs. TNFi monotherapy | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on tofacitinib monotherapy vs tofacitinib with MTX | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on TNFi monotherapy vs TNFi combination with MTX | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi combination with MTX | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi monotherapy | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs TNFi combination with MTX | 6 months | 
| Achievement of mACR20 | Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs. TNFi monotherapy | 6 months | 
| Proportion of patients in 1st line (no prior use of any DMARD at time of initiation) | Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib | Baseline | 
| Proportion of patients 2nd line (prior use of at least one csDMARD and no prior use of any biologic) | Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib. | Baseline | 
| Proportion of patients 3rd line (prior use of at least one csDMARD and prior use of 1 biologic) | Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib. | Baseline | 
| Proportion of patients 4th line or later (prior use of at least one csDMARD and prior use of 2+ biologics) | Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib. | Baseline | 
| Proportion of 3rd line + patients with exposure to adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, abatacept, rituximab, tocilizumab, or anakinra | Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib. | Baseline | 
| Median age, years | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline | 
| Percent Female | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline | 
| Percent White | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline | 
| Median duration of RA in years | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline | 
| Median CDAI | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline | 
| Percent bDMARD-naïve | Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy. | Baseline |