Adalimumab, Uveitis
Conditions
Keywords
Uveitis, Adalimumab, TNF-α inhibitor
Brief summary
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
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.
Interventions
BIOLOGICALreduction or discontinuation of Adalimumab
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.
Sponsors
Dan Liang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| relapse rate of inflammation | 24 months | The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual Acuity | 24 months | increase of BCVA |
| macular structure | 24 months | Macular thickness (MT). increase of central foveal thickness |
Countries
China
Contacts
Primary ContactDan Liang, PhD
Outcome results
None listed