Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: To evaluate the long-term safety and efficacy of adalimumab (Humira®) in patients with non-infectious intermediate, posterior, or panuveitis (NIPPU) in an open-label clinical trial extension, VISUAL-III.
Methods: Adults who met treatment failure or study completion criteria in VISUAL-I/VISUAL-II and opted to enroll in VISUAL-III received adalimumab 40-mg every other week. Corticosteroids and/or immunosuppressive therapy were permitted as needed. Patients that discontinued VISUAL-I/VISUAL-II due to treatment failure had active disease at VISUAL-III entry. Efficacy endpoints included new inflammatory lesions, anterior chamber (AC) cell, and vitreous haze (VH) grades from study entry (week-0) through week-54 (inactive uveitis) and week-78 (active uveitis). Corticosteroid daily dose was measured over time. Adverse event rates were reported from first adalimumab dose in VISUAL-I/II/III until the data cutoff of 31-August-2015.
Results: Intent-to-treat analyses included 243 (active) and 128 (inactive) uveitis patients at study entry. At week-54, no new inflammatory lesions relative to baseline, AC cell and VH grades of ≤0.5+ were observed in 98.5%, 98.5% and 92.6% of inactive uveitis patients, respectively. At week-78, no new inflammatory lesions relative to week-8, AC cell and VH grades of ≤0.5+ were observed in 96.3%, 91.0% and 87.8% of active uveitis patients, respectively. Mean systemic corticosteroid daily dose decreased from 12.7 to 3.68 prednisone equivalents by year 1 for patients with active uveitis and remained stable from 1.48 to 1.21 prednisone equivalents for inactive patients. Adverse events rates (577 AE/100PY and 19.6 SAE/100PY) were comparable to the VISUAL-I and VISUAL-II trials.
Conclusion: Long-term adalimumab treatment reduced ocular inflammation and corticosteroid burden in NIPPU patients and demonstrated a safety profile consistent with other indications and previous VISUAL studies.
To cite this abstract in AMA style:Suhler EB, Jaffe GJ, Nguyen QD, Brezin AP, Zierhut M, Vitale A, van Velthoven M, Adan A, Lim L, Kramer M, Schlaen A, Fortin E, Muccioli C, Goto H, Kaburaki T, Camez A, Song AP, Kron M, Tari S, Dick AD. Long–Term Safety and Efficacy of Adalimumab in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis in an Ongoing Open-Label Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-adalimumab-in-patients-with-non-infectious-intermediate-posterior-or-panuveitis-in-an-ongoing-open-label-study/. Accessed May 30, 2020.
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