SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Two retrospective studies that evaluated the use of SIMPONI ARIA for the treatment of anterior uveitis are described below.^1,2

CLINICAL DATA

Retrospective Study

Khan et al (2024)¹ conducted a retrospective, observational case series to evaluate the efficacy and safety of SIMPONI ARIA in treating juvenile idiopathic arthritis (JIA)-associated anterior uveitis.

Study Design/Methods

• Electronic records of patients diagnosed with JIA-associated anterior uveitis who had failed:
  • One or more conventional agent (eg, methotrexate [MTX], cyclosporine A, azathioprine, mycophenolate mofetil)
  • One biologic response modifier agent (eg, adalimumab, infliximab, tocilizumab, sarilumab, abatacept, ustekinumab) and had received SIMPONI ARIA were examined.
• Patients were excluded if they had any type of uveitis other than anterior uveitis.
• SIMPONI ARIA was administered at a dose of 2 mg/kg or 80 mg/m² per the pediatric rheumatologist’s decision. The medication was infused over 30 min at 0 and 4 weeks as loading doses and then every 8 weeks thereafter.
• The primary outcome was induction and maintenance of remission, and the secondary outcome was improvement in the best-corrected visual acuity (BCVA).
• Remission was defined as the absence of anterior chamber (AC) reaction and vitreous haze due to active inflammation, the lack of disc and vascular leakage post 3 months of treatment initiation without corticosteroid use on fluorescein angiography, and the normal or near normal macular structure on optical coherence tomography maintained for 3 consecutive months without any corticosteroid treatment.

Results

• Overall, 24 eyes of 13 patients were included in the study. For detailed demographics and disease and treatment characteristics of patients with JIA-associated uveitis, see Table: Demographics and Disease and Treatment Characteristics of Patients with JIA-Associated Uveitis.

• Before starting SIMPONI ARIA, all patients had used at least 1 conventional agent and 1 biologic response modifier. On average, patients used 2.6±1 (range, 2-5) immunomodulatory therapies (IMTs) for a duration of 52.46±38.42 months (range, 6-120).
• During 12 months before starting SIMPONI ARIA, the median grade of AC reaction was 1 (range, 0.5-3) and the median number of flare-ups was 1 (range, 1-3). However, during 12 months after starting SIMPONI ARIA (excluding the first 2 months, ie, the loading dose period), the median grade of AC reaction and the number of flare-ups decreased to 0 (range, 0-1).
• Prior to SIMPONI ARIA therapy, the average logarithm of the minimum angle of resolution (logMAR) BCVA was 0.68±0.68 (range, -0.1 to 3); it improved to 0.4±0.93 at 3 months (range, -0.1 to 3), 0.38±0.94 at 6 months (range, -0.1 to 3), and 0.4±0.9 at 12 months (range, -0.1 to 3) after initiation of SIMPONI ARIA. Cystoid macular edema was present in 25% (6/24) of eyes in 23% (3/13) of patients and resolved in all eyes within 3 months of starting SIMPONI ARIA therapy.
• Overall, 85% (11/13) patients responded to SIMPONI ARIA therapy. All patients continued SIMPONI ARIA therapy until their most recent visit, except for 1 patient who was switched to subcutaneous golimumab by the pediatric rheumatologist for unknown reasons. This patient also maintained remission.
  • All patients were on at least 1 conventional IMT in addition to SIMPONI ARIA therapy.
  • SIMPONI ARIA therapy was discontinued due to ineffectiveness (n=1; patient was human leukocyte antigen [HLA]-B27 positive) and development of psoriasis (n=1; patient was HLA-B27 negative).

Miraldi Utz et al (2022)² conducted a retrospective study to evaluate the use of SIMPONI ARIA in pediatric patients (<18 years old) with refractory, noninfectious, chronic anterior uveitis (CAU) who had a history of treatment failure with MTX and ≥1 conventional tumor necrosis factor inhibitor (TNFi).

Study Design/Methods

• The primary outcome was control of CAU, defined by the following:
  • AC cell grade 0 (1 mm² field size) in the affected eye or eyes described by the terms “quiet,” “quiescent,” and “no active inflammation”.
  • Absence of vitreous haze or other indications of CAU activity on a dilated eye examination or imaging.
  • ≤2 drops of prednisolone acetate 1% or equivalent/day.
  • No requirement for oral corticosteroids.

Results

• Among the 52 patients who were included in the study, 9 received alternative biologic treatment with or without disease-modifying antirheumatic drugs (DMARDs), of whom 2 received SIMPONI ARIA.
  • Patient 1 was a 13.4-year-old female.
    • The patient developed diffuse urticaria with the first infusion of tocilizumab and discontinued therapy.
  • Patient 2 was a 20.7-year-old male.
    • The patient was antinuclear antibody (ANA) positive but did not have any arthritis (the age at presentation was >16 years and the patient did not meet the criteria of JIA). The authors suspected that the JIA presentation was masked by uveitis therapy. After SIMPONI ARIA was abruptly discontinued when the patient moved out of state, they developed left knee arthritis and recurrent CAU. Reinitiation of SIMPONI ARIA therapy led to remission of uveitis. For consistency, only the first treatment period was analyzed.
• For detailed clinical and treatment characteristics of these 2 patients who received SIMPONI ARIA, see Table: Clinical and Treatment Characteristics of Patients Who Escalated to SIMPONI ARIA.

• Rationale for SIMPONI ARIA therapy in patients 1 and 2 is presented in the Table: Rationale for Treatment Escalation to SIMPONI ARIA.

• No new complications occurred during alternate biologic therapy.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 05 February 2025.