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Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective,
P D Yuan1,2, Y W Hu1,3, X Q Chen1
1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Sun Yat-sen University, Guangzhou, China.
Insights
Reducing or stopping adalimumab (ADA) in children with stable pediatric non-infectious uveitis (PNIU) led to a high risk of inflammation recurrence. Reinstating ADA at its last effective dose frequency helped regain disease control.
Area of Science:
- Ophthalmology
- Immunology
- Pediatrics
Background:
- Pediatric non-infectious uveitis (PNIU) requires long-term management, often with biologic agents like adalimumab (ADA).
- Optimizing ADA treatment strategies, including dose reduction and withdrawal, is crucial for managing PNIU in children while minimizing treatment burden and potential side effects.
Purpose of the Study:
- To evaluate the feasibility and outcomes of a dose reduction and withdrawal strategy for adalimumab in children with stable PNIU.
- To assess the risk of inflammation recurrence and the effectiveness of resuming ADA treatment after dose modification or discontinuation.
Main Methods:
- An open-label prospective pilot trial involving 18 stable PNIU patients (aged 2-18 years) treated with ADA and methotrexate.
- Patients initially had their ADA interval extended from 2 to 4 weeks, followed by complete withdrawal if stable, with follow-up for 48 weeks.
- Key outcomes included relapse-free survival, visual acuity, ocular inflammation markers (anterior chamber cells, vitritis), macular thickness, and serum ADA levels.
Main Results:
- A significant relapse rate was observed: 33.3% during dose reduction (ADA every 4 weeks) and 44.5% after withdrawal.
- Only 22.2% of patients remained relapse-free at 48 weeks; successful withdrawal occurred in 4 patients, all diagnosed with Behçet's disease (BD).
- While visual acuity and macular thickness remained stable, ocular inflammation markers (anterior chamber cells, vitritis) showed an increasing trend; serum ADA levels decreased over time.
Conclusions:
- Dose reduction and withdrawal of adalimumab in stable PNIU patients carries a high risk of recurrent inflammation.
- Resuming adalimumab at the last effective dosage frequency can effectively control inflammation.
- Monitoring serum ADA levels in patients experiencing recurrence may aid in determining optimal dosing intervals.
Purposes:
This study investigated the feasibility of adalimumab (ADA) dose reduction and withdrawal strategy in children with stable pediatric non-infectious uveitis (PNIU).
Methods:
This open-label prospective pilot trial recruited 18 stable PNIU patients (33 eyes) between two and eighteen years old who were treated with standard doses of ADA (20/40 mg every 2 weeks) plus oral methotrexate. The interval of ADA injection was extended to 4 weeks and followed up for 24 weeks. If the uveitis remained stable, ADA was discontinued and followed up for another 24 weeks. ADA was considered successfully stopped if no relapse occurred during this period. The relapse-free survival rate, best corrected visual acuity (BVCA), anterior chamber cell (ACC), vitritis, macular thickness (MT), and serum ADA levels were evaluated. Approval Number: 2021KYPJ201. ClinicalTrials.gov identifier: NCT05155592.
Results:
The relapse-free survival rate was 22.2% (4/18) at 48 weeks. 33.3% (6/18) of patients relapsed when ADA was given every 4 weeks, while 44.5% of patients (8/18) relapsed after ADA was stopped. The four patients successfully withdrawn from ADA were all diagnosed with BD. No statistically significant differences (p > 0.05) were observed in BCVA and MT between baseline and final follow-up. The proportion of ACC and vitritis exhibited an upward trend (p < 0.05) during follow-up. Serum ADA gradually decreased to zero during follow-up in both non-recurrence and recurrence groups.
Conclusions:
In PNIU children who reached remission for 6 months, ADA dose reduction and withdrawal were associated with a high risk of inflammation recurrence. Timely adjustment of ADA to the last effective dosage frequency can regain control of the inflammation. Detection of ADA serum levels in patients with recurrence may help find the appropriate interval of ADA use.
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