A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy

Study Overview
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Brief Summary
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The purpose of the study is to compare the risk of dementia in participants diagnosed with rheumatoid arthritis (RA) exposed to anti-tumor necrosis factor (TNF) therapy versus those exposed to methotrexate.

Official Title
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Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy

Conditions
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Dementia, Alzheimer Disease

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Anti-TNF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one claim for methotrexate or anti-TNF therapy during the study period. First medication received is the index medication, and date of first receipt is the index date 365 days of continuous pre-index observation immediately prior to the index date Participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date No prior use of methotrexate or an anti- tumor necrosis factor (TNF) therapy at any time prior to the index date Cohort follow-up persists until end of continuous observation or filling the comparator drug

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Participants Initiating Therapy with Methotrexate or Anti-TNF<br>Data will be collected for participants initiating therapy with either methotrexate or an anti-tumor necrosis factor (TNF) from united states (US) claims databases: optum de-identified clinformatics data mart database and IBM marketscan medicare supplemental database (MDCR). Data collection period: 01-Jan-2000 through 31-Jul2019. | Drug: Methotrexate<br>* No intervention or treatment will be administered as part of this study. Data of participants with first claim for a methotrexate in the patient's history are included.<br>Drug: Anti-TNF<br>* No intervention or treatment will be administered as part of this study. Data of participants with first claim for an anti-TNF in the patient's history are included. Anti-TNF includes infliximab, golimumab, etanercept, certolizumab, and adalimumab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly Diagnosed Dementia Cases | An outcome of dementia requires at least two diagnosis codes international classification of diseases, ninth revision, clinical modification (ICD-9-CM) or international classification of diseases, tenth revision, clinical modification (ICD-10-CM) for dementia within 365 days of each other. | 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly Diagnosed Alzheimer's Disease (AD) Cases | An outcome of AD requires at least two diagnosis codes (ICD-9-CM or ICD-10-CM) for AD within 365 days of each other. | 365 days |