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

Dan Liang

Status and phase: Unknown; Phase 2

Conditions: Uveitis; Adalimumab

Treatments: Biological: reduction or discontinuation of Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05155592

2021-ADA-Stop

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 2 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

28 participants in 1 patient group

Patients with inactive uveitis

Experimental group

Description:

Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab

Treatment:

Biological: reduction or discontinuation of Adalimumab