A Study to Understand How Effective is Tofacitinib When Compared to Other Advanced Treatments in Patients With Rheumatoid Arthritis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-07-19

Brief Summary

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The purpose of this study is to learn how different types of medicines may improve disease activity in people with rheumatoid arthritis (RA). RA is a kind of joint disease that causes pain and swelling.

The study will look at data from a large, US-based group of RA patients who have taken the below medicines:

* Tofacitinib
* Abatacept
* Tocilizumab or sarilumab

The study will compare clinical disease activity scores of patients on the different medicines taken. The study will also decide whether some patient traits or disease factors play a role in how medicines may improve disease activity.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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rheumatoid arthritis

Patients diagnosed with rheumatoid arthritis

tofacitinib

Intervention Type DRUG

New index treatment of tofacitinib

tumor necrosis factor inhibitors (TNFi)

Intervention Type DRUG

New index treatment of TNFi

abatacept

Intervention Type DRUG

New index treatment of abatacept

tocilizumab or sarilumab

Intervention Type DRUG

New index treatment of tocilizumab or sarilumab

Interventions

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tofacitinib

New index treatment of tofacitinib

Intervention Type DRUG

tumor necrosis factor inhibitors (TNFi)

New index treatment of TNFi

Intervention Type DRUG

abatacept

New index treatment of abatacept

Intervention Type DRUG

tocilizumab or sarilumab

New index treatment of tocilizumab or sarilumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years on the cohort entry date.
2. Diagnosed with rheumatoid arthritis (RA) at any time prior to cohort entry date:

1. At least two RA diagnosis codes at least 30 days apart, each coming from an encounter with a rheumatologist;
2. At least one inpatient visit with a RA diagnosis code;
3. At least two outpatient records with a RA diagnosis code at least 30 days apart and within a year, regardless of physician specialty; or
4. At least one outpatient record with an RA diagnosis and a prescription or fill for a disease modifying anti-rheumatic drug (DMARD) from a specified list and does not have any of the non-RA conditions for which those drugs may also be prescribed.
3. Initiation of specified biologic or targeted synthetic molecule DMARDs of interest for treatment of RA (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept, tocilizumab, or sarilumab).
4. At least 180 days of baseline data available prior to and including the cohort entry date.
5. At least one Clinical Disease Activity Index (CDAI) score in 45 days prior to and including the cohort entry date (baseline).

Exclusion Criteria

1. Patients diagnosed with concomitant indications for tofacitinib \[psoriatic arthritis (PsA), UC, and polyarticular course juvenile idiopathic arthritis (pcJIA)\] at any time prior to cohort entry date, determined by at least two (2) diagnosis codes at least 30 days apart and prior to baseline.
2. Patients with \>1 b/tsDMARD (ie, tofacitinib, etanercept, adalimumab, certolizumab, golimumab, infliximab, abatacept tocilizumab, or sarilumab) prescribed on index date.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No