Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients

Study Overview
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Brief Summary
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TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Detailed Description
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TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Official Title
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Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis

Conditions
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Uveitis, Adalimumab

Intervention / Treatment
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* Biological: reduction or discontinuation of Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of non-infectious uveitis nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy Family members and patients who are willing to stop should agree and accept relevant examinations The informed consent is read and signed by the patient or a legally authorized represent Exclusion Criteria: Unwilling to sign informed consent There is systemic autoimmune disease uncontrolled situation Patients who may require surgery in the near future Vision meets the standards of low vision and blindness Silicone oil or gas filling after vitreous surgery

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with inactive uveitis<br>Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab | Biological: reduction or discontinuation of Adalimumab<br>* For patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate of inflammation | The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual Acuity | increase of BCVA | 24 months | 
| macular structure | Macular thickness (MT). increase of central foveal thickness | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveitis, Adalimumab, TNF-α inhibitor