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While methotrexate (MTX) remains a treatment of choice for patients with rheumatoid arthritis (RA), psoriasis (PsO) and psoriatic arthritis (PsA), long-term MTX use has been shown to be associated with liver fibrosis and cirrhosis in these patients. In addition, gut dysbiosis has been found to be associated with liver fibrosis and cirrhosis via the gut-liver axis, underscoring the potential role of gut microbiota and bacterial translocation in the pathogenesis of chronic liver diseases in these patients.
In this study, we aim to assess the prevalence of advanced liver fibrosis or cirrhosis among these patients on MTX treatment compared to those without, using transient elastography. We also aim to identify the possible risk factor(s) for advanced liver fibrosis or cirrhosis among them. Further, we aim to characterize the difference in fecal microbiota patterns among these three groups of patients.
Using a cross-sectional, prospective cohort design, this study will enroll approximately 600 eligible patients, including 300 patients with PsO/PsA and 300 patients with RA, to examine the following hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSO/PSA | Patients diagnosed with psoriasis or psoriatic arthritis | ||
| RA | Patients diagnosed with rheumatoid arthritis |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with advanced liver fibrosis or cirrhosis | We will measure the number of patients with significant fibrosis (defined as having liver stiffness ≥ 7.5 kPa in transient elastography), and among those who undergo biopsy, the number of patients whose biopsy specimen is of Roenigk grades 3b or 4 | At the time of the assessment procedure |
| The type and abundance of fecal microbiota patterns | We will measure the type and abundance of various bacteria/viruses in specimens; alpha diversity within a specimen and beta diversity between groups of specimen; specific taxa that differ significantly between groups; and metabolic profiles and functional pathways associated with change in gut microbiota | At the time of the assessment procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The risk factors of liver fibrosis | Risk factors to be examined will include demographic variables such as age and gender, cumulative dose of MTX, gut dysbiosis, duration of disease, co-morbidities, hepatic steatosis, liver stiffness, and other potential factors | At the time of the assessment procedure |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital, with a diagnosis of PsO/PsA and/or RA will be identified and screened for eligibility.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sze-Man Wong, MSc, MRCP | Contact | +852 22555154 | wongsm11@ha.org.hk |
| Name | Affiliation | Role |
|---|---|---|
| Sze-Man Wong, MSc, MRCP | Queen Mary Hospital, Hong Kong | Principal Investigator |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Blood (serum and plasma) and stool samples collected for this study will be saved for 3 years and stored at - 80 degree Celsius in the laboratory in Hong Kong for biomarker analyses.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |