Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

Study Overview
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Brief Summary
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This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

Detailed Description
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This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.

Official Title
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Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

Conditions
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Drug Use, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: biologic/targeted therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All RA patients in our biologics registry treated with the JAK inhibitors (N=411) All RA patients in our biologics registry treated with the TNF inhibitors (N=1392) Exclusion Criteria: - RA patients in our biologics registry treated with other biologic/targeted DMARDs

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 |
| --- | --- |
| JAK inhibitors<br>RA patients treated with JAK inhibitors | Drug: biologic/targeted therapy<br>* TNF inhibitors or the JAK inhibitors<br>|
| TNF inhibitors<br>RA patients treated with TNF inhibitors | Drug: biologic/targeted therapy<br>* TNF inhibitors or the JAK inhibitors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal rate due to major / serious adverse events | adverse events eg. MACEs, malignancy, infections | from start of biologic/targeted DMARD use to these event(s) up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal rate due to inefficacy | Efficacy of the agents in terms of retention rate | from start of biologic/targeted DMARD use to last clinic visit up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthitis, biological agents, targeted agents