Adalimumab Dose Reduction and Withdrawal in Stable Non-Infectious Pediatric Uveitis: An Open-Label, Prospective, Pilot Study

Figures & data

Figure 1. An adalimumab dose reduction and withdrawal protocol by extending the dosing interval. (Adalimumab 20 mg for the patient less than 30 Kg and 40 mg for those over 30 Kg).

Table 1. Demographic characteristics of children with stable non-infectious uveitis.

Characteristics	Value
Num. of children (eyes)	18 (33)
Sex; n (%)
Male	7 (38.9%)
Female	11 (61.1%)
Age; mean ± SD years	8.1 ± 3.0
Laterality; n (%)
Unilateral	3 (16.7%)
Bilateral	15 (83.3%)
Pattern of uveitis; n (%)
Intermediate	2 (11.1%)
Pan-uveitis	16 (88.9%)
Systemic diagnosis; n (%)
Idiopathic uveitis	7 (38.9%)
Behçet’s Disease	7 (38.9%)
Juvenile idiopathic arthritis	4 (22.2%)
Duration of ADA induction period before attaining remission; mean ± SD months	5.2 ± 1.5
Duration of remission before ADA dose reduction; mean ± SD months	6.5 ± 2.6
Duration of follow-up; mean ± SD months	13.7 ± 2.5

Abbreviation: n = patients, SD = standard deviation, ADA = adalimumab.

Figure 2. Kaplan-Meier survival curves showing relapse-free survival of all stable NIU patients after ADA dose reduction and withdrawal during the follow-up time. n = patients.

Table 2. Clinical and treatment features of non-infectious uveitis children before and after adalimumab-dose reduction and withdrawal.

Characteristics	Before	Last follow-up
Relapse, n	N/A	14 (77.8%)
Adalimumab Dosage, n (%)
40 mg	13 (72.2)	9 (50.0%)
20 mg	5 (27.8%)	3 (16.7%)
0 mg	0	6 (33.3%)
Adalimumab Interval, n (%)
2 weeks	18 (100%)	6 (33.3%)
3 weeks	0	2 (11.1%)
4 weeks	0	4 (22.3%)
Stop	0	6 (33.3%)
Systemic treatment
Oral glucocorticoid, n (%), mg/day	0	3 (16.7%), 0.6 ± 0.1
Immunosuppressive therapy
MTX, n (%), mg/week	18 (100%), 14.0 ± 2.3	15 (83.3%),13.2 ± 3.3
MMF, n (%), mg/day	0	3 (16.7%), 916.7 ± 144.3
CSA, n (%), mg/day	0	1(5.6%), 100
Clinical parameters
BCVA, mean ± SD	0.9 ± 0.2	0.9 ± 0.2
CMT(μm), mean ± SD	211.0 ± 16.8	216.1 ± 26.5
ACC (eyes, %)	0	17 (51.5%)
Vitritis (eyes, %)	0	15 (45.5%)
Ocular complications, eyes (%)
Cataract	12 (36.4%)	12 (36.4%)
Pseudophakia	2 (6.1%)	2 (6.1%)
Band keratopathy	5 (15.2%)	5 (15.2%)
Cystic Macular edema	0	0
Synechia	7 (21.2%)	7 (21.2%)
Type of adverse event, n (%)
Gastrointestinal discomfort	N/A	3 (16.7%)

Abbreviation: n = patients, MTX = Methotrexate, CSA = Cyclosporine A, MMF = Mycophenolate Mofetil, BCVA = Best Corrected Visual Acuity, CMT = Central Macular Thickness, ACC = Anterior chamber cell, SD = standard deviation.

Figure 3. Change of BCVA (A) and CMT (B) after ADA dose reduction and withdrawal during the follow-up time. BCVA: best corrected visual acuity, CMT = central macular thickness. n = eyes.

Figure 4. Change of anterior chamber cell (ACC) grade (A) and vitritis grade (B) after ADA dose reduction and withdrawal during the follow-up time. n = eyes.

Figure 5. (A) All patients’ ADA serum trough level gradually decreased during follow-up, and decreased to 0 at the last visit. (B,C) The ADA serum trough level decreased gradually to 0 over time in both the non-relapse group (B) and relapse group (C) n = patients.

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.