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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with inactive uveitis | Experimental | Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reduction or discontinuation of Adalimumab | Biological | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual Acuity | increase of BCVA | 24 months |
| macular structure | Macular thickness (MT). increase of central foveal thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Liang, PhD | Contact | 0086-20-87330402 | liangd2@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dan Liang, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38652891 | Derived | Yuan PD, Hu YW, Chen XQ, Chen GY, Pan Y, Lao HY, Liang D. Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study. Ocul Immunol Inflamm. 2025 Apr;33(3):332-339. doi: 10.1080/09273948.2024.2343084. Epub 2024 Apr 23. | |
| 37172782 | Derived | Teabagy S, Wood E, Bilsbury E, Doherty S, Janardhana P, Lee DJ. Ocular immunosuppressive microenvironment and novel drug delivery for control of uveitis. Adv Drug Deliv Rev. 2023 Jul;198:114869. doi: 10.1016/j.addr.2023.114869. Epub 2023 May 10. |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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|
| 24 months |