Investigating the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents

Study Overview
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Brief Summary
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An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

Official Title
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An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

Intervention / Treatment
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* Biological: Originator
* Biological: Biosimilar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who are being treated at a participating OPAL clinic. Exclusion Criteria: -

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 |
| --- | --- |
| Originator<br>Originator anti-TNF agents. Dosage as per physician's decision based on approved indication. | Biological: Originator<br>* Originator anti-TNF agents<br>* Other names: All other originator anti-TNF agents;|
| Biosimilar<br>Biosimilar anti-TNF agents. Dosage as per physician's decision based on approved indication. | Biological: Biosimilar<br>* Biosimilar anti-TNF agents<br>* Other names: All other anti-TNF biosimilars as they come to market;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity score based on a 28 joint count (DAS28) | Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity. | 3 years | 
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Comparative assessment of disease impact on quality of life and daily physical functions in patients receiving originators vs biosimilars. HAQ-DI is designed to measure impact on everyday life. Higher scores indicate more severe disability. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36-item Short Form Health Survey (SF-36) | Comparative assessment of disease impact on quality of life in patients receiving originators vs biosimilars. The SF-36 uses 8 sub scales to assess patient vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each sub scale is scored between 0-100, where lower scores indicate a greater impact on function. | 3 years | 
| Patient Health Questionnaire-2 (PHQ-2) | Comparative assessment of disease impact on the emotional health in patients receiving originators vs biosimilars, as measured by the PHQ-2. The PHQ-2 is a two-question survey to screen for depression, and higher scores indicate that the patient experienced depressed mood or anhedonia more frequently over the past two weeks. | 3 years | 
| Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire | Comparative assessment of fatigue in patients receiving originators vs biosimilars, assessed using the FACIT-fatigue scale. FACIT-fatigue is a questionnaire used to measure fatigue levels in patients with rheumatoid arthritis. A higher score is associated with a greater level of fatigue. | 3 years | 
| Number of patients discontinuing the drug for safety reasons | Comparison between number of patients using originator vs biosimilar who discontinue therapy for safety reasons. | 3 years |