Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation

Ki vehet részt

• For the Prospective New-User Cohort, verification of Inclusion Criteria 1 through 6 is required
• For the Retrospective (Switch) Cohort, verification of Inclusion Criteria 1 through 7 is required; Pediatric patients aged 2 years and < 18 years; Diagnosed with non-infectious anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis; Active intraocular inflammation demonstrated by anterior chamber (AC) cell grade ≥ 1+ (defined as 6 cells per 1 mm\times 1 mm field) according to the SUN (Standardization of Uveitis Nomenclature) criteria, or active posterior segment lesions persistently observed on at least two consecutive assessments despite 12 weeks of treatment with methotrexate and corticosteroids (systemic or topical) prior to screening (SUN grade maintained on 2 occasions, adapted from the SYCAMORE trial definition of active disease); Inadequate response to corticosteroid therapy or other immunosuppressive agents (e.g., methotrexate [MTX]), or inability to continue treatment due to unacceptable toxicity/intolerance; Written informed consent obtained from the subject's legal representative (parent or legal guardian) and written pediatric assent obtained according to applicable age-specific regulatory and institutional guidelines; [Prospective De Novo Cohort]; Patients initiating adalimumab for the first time (adalimumab-naïve); [Retrospective / Prospective Cohort] 6. Patients currently on maintenance therapy with adalimumab (including extended dosing intervals, such as every other week [Q2W] or every 3-4 weeks) who require at least 1 additional year of treatment
• Patients who agree to switch to the investigational product and adhere to a standard every-other-week (Q2W / once every 2 weeks) administration schedule at the time of study enrollment

Ki nem vehet részt

• For the Retrospective (Switch) Cohort, verification of Exclusion Criteria 1 through 24 is required; Patients with uveitis associated with juvenile idiopathic arthritis (JIA) or pediatric Crohn's disease indicated for adalimumab; Individuals with infectious uveitis or non-immunological intraocular inflammation resulting from trauma, surgery, etc., within 30 days prior to screening; Individuals with active tuberculosis, untreated latent tuberculosis, sepsis, opportunistic infections, or other severe active infections, or those at high risk for such infections; Individuals with a history of hypersensitivity to adalimumab or any of its excipients; Individuals instilling topical glucocorticoids more than 6 times per eye per day, or currently receiving oral prednisone (or its equivalent) at a dose exceeding 0.2 mg/kg/day (adapted from the SYCAMORE criteria); Individuals with active malignancy, lymphoproliferative disorders, demyelinating disease (e.g., multiple sclerosis, Guillain-Barré syndrome), or a history of other progressive or degenerative neurological disorders; Patients who have received TNF inhibitors other than the investigational product; Patients with New York Heart Association (NYHA) Class III/IV cardiac disease; Individuals with uncontrolled viral infections, including active hepatitis B or hepatitis C; Individuals who have received a live vaccine (including live-attenuated vaccines) within 30 days prior to screening, or who are scheduled to receive one during the study period; Individuals who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) who do not agree to use highly effective contraception*; *A highly effective method of contraception is defined as one that results in a low failure rate of less than 1% per year when used consistently and correctly, and includes: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; and sexual abstinence; Individuals who have received other biologic agents within 5 half-lives prior to screening; Individuals with a family member who has active tuberculosis, or who have a history of close contact with an individual with active tuberculosis; Individuals with a major infection requiring antibiotic therapy within 30 days prior to screening; Individuals with diabetes mellitus deemed uncontrolled by the investigator, or persistently uncontrolled severe hypertension (> 95th percentile for height and age); Individuals with a history of malignancy, or a history of solid organ, bone marrow, or corneal transplantation; Individuals with a history of ocular surgery (e.g., cataract surgery) within 3 months prior to screening; Individuals who have received intraocular or periocular corticosteroid injections within 30 days prior to screening; Individuals with a history of ocular herpes simplex or herpes zoster infection; Individuals with laboratory values evaluated during screening that meet any of the following criteria:; Hemoglobin < 8.0 g/dL B. WBC < 4.0 × 10³/µL C. ANC < 1.0 × 10³/µL D. Platelet count < 100 × 10³/µL E. AST or ALT > 2 × ULN; Individuals weighing less than 15 kg; Individuals otherwise deemed unsuitable for study participation in the judgment of the investigator; [Retrospective / Prospective Cohort-Specific Criteria]; Inability to confirm disease activity (e.g., SUN grading) at the initial start of adalimumab treatment and subsequent treatment response via medical record review; Patients whose adalimumab dosage has been tapered to near-discontinuation (i.e., dosing intervals substantially exceeding once every 4 weeks) or for whom the treating physician deems the standard maintenance regimen (once every 2 weeks) clinically inappropriate
• For the Prospective New-User Cohort, verification of Exclusion Criteria 1 through 22 is required