Long-Term Safety and Efficacy of Adalimumab in Patients with Noninfectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis

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چکیده

PurposeTo evaluate long-term efficacy and safety of extended treatment with adalimumab in patients noninfectious intermediate, posterior, or panuveitis.DesignOpen-label, multicenter, phase 3 extension study (VISUAL III).ParticipantsAdults who had completed a randomized, placebo-controlled parent trial I II) without failure (inactive uveitis) discontinued the after meeting criteria (active uveitis).MethodsPatients received subcutaneous 40 mg every other week. Data were collected for ? 362 weeks. Adverse events (AEs) recorded until 70 days last dose.Main Outcome MeasuresLong-term quiescence; variables included inflammatory lesions, anterior chamber cell vitreous haze grade, macular edema, visual acuity, dose uveitis-related systemic corticosteroids.ResultsAt entry, 67% (283/424) showed active uveitis 33% (141/424) inactive uveitis; 60 subsequently met exclusion criteria, 364 intention-to-treat analysis. Efficacy analyzed through week 150, when approximately 50% (214/424) remained study. Patients showing quiescence increased from 34% (122/364) at 0 to 85% (153/180) 150. Corticosteroid-free was achieved by 54% (66/123) 89% (51/57) entry. Mean daily corticosteroids reduced 9.4 ± 17.1 mg/day (n = 359) 1.5 3.9 150 181). The percentage over time those entry maintained uveitis. most frequently reported treatment-emergent AEs special interest infections 275; 79 events/100 patient-years [PY]); serious occurred rate 396 PY 15 PY, respectively.ConclusionsLong-term led corticosteroid use entered VISUAL III maintenance comparable trials consistent known profile adalimumab. To panuveitis. Open-label, III). Adults uveitis). dose. Long-term corticosteroids. At respectively.

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ژورنال

عنوان ژورنال: Ophthalmology

سال: 2021

ISSN: ['2468-7162', '2468-7170']

DOI: https://doi.org/10.1016/j.ophtha.2020.10.036