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Mohammad Ali Sadiq, Muhammad Hassan, Muhammad Sohail Halim, Rubbia Afridi, Diana V Do, Quan Dong Nguyen, Yasir Jamal Sepah; Posterior Segment Inflammatory Outcomes (Month-6) in the STOP-Uveitis Study: Evaluating the Safety, Tolerability, and Efficacy of Tocilizumab in Patients with Non-Infectious Uveitis. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5949. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To report the posterior segment inflammatory outcomes of two different doses of intravenous (IV) infusions of tocilizumab (TCZ), an IL-6 inhibitor, in eyes with non-infectious intermediate, posterior or pan-uveitis using a semi-quantitative fluorescein angiography (FA) leakage scoring system.
STOP-Uveitis is a randomized, multi-center clinical trial conducted at 5 centers across the United States. The study evaluated the role of TCZ in patients with non-infectious uveitis (NIU). 37 subjects with NIU were randomized into one of 2 treatment groups in a ratio of 1:1. Group 1 received intravenous (IV) infusions of 4mg/kg TCZ; group 2 received IV infusions of 8mg/kg TCZ. Infusions were given every 4 weeks in both groups until month 6 (primary endpoint). Posterior segment inflammatory outcomes were assessed via evaluating fluorescein angiograms (FA) at baseline and month 6 visits by trained graders at a central reading center. A previously reported, semi-quantitative, scoring system for FA was used to assess signs of inflammation that represent inflammatory processes in the posterior segment (Table 1). These FA signs included optic disc hyperfluorescence, macular edema, retinal vascular staining and/or leakage, capillary leakage, retinal capillary nonperfusion, , pinpoint leaks, and retinal staining and/or subretinal pooling. Statistical analysis was performed using student t-test; statistical significance was set at p<0.05.
37 eyes (37 subjects) were randomized in the STOP-Uveitis study. 30 eyes were found to be eligible for the FA analysis based on study criteria. 7 eyes had ungradable images at either BL or M6 and were therefore excluded from the analysis. Table 2 shows the mean composite FA scores at BL and M6 in the two treatment groups. The reduction in FA scores at month 6 was statistically significant in both groups (p<0.05). The difference between the two groups was not significant (p=0.351).
TCZ is effective in improving posterior segment inflammation, as assessed by FA, in eyes with non-infectious intermediate, posterior and pan-uveitis. The higher dose of TCZ does not appear to provide additional benefits over the lower dose in improving inflammatory outcomes.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
Table 2 – Mean FA inflammatory scores at Baseline and Month 6
Table 1 – FA Scoring System for Uveitis
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