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

Dan Liang28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveitis Adalimumab

Interventions

reduction or discontinuation of AdalimumabBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

relapse rate of inflammation

The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation

Time frame: 24 months

Secondary Outcomes

Best corrected visual Acuity

increase of BCVA

Time frame: 24 months

macular structure

Macular thickness (MT). increase of central foveal thickness

Time frame: 24 months

Central Contacts

Dan Liang, PhD

CONTACT

0086-20-87330402 liangd2@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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