(i) SK 300 mg s.c. at baseline, week 1 and week 2 (loading phase), and then every 2 weeks (ii) SK 300 mg s.c. loading phase and then monthly (iii) Placebo s.c. loading phase and then every 2 weeks
(i) Greater reduction in mean total postbaseline composite immunosuppressive medication (ISM) in the SK group compared with placebo (ii) No statically significant differences in change in BCVA between the SK group and placebo (iii) Median decrease in vitreous haze was similar among treatment groups
INSURE Phase III
31
(i) SK 300 mg s.c. loading phase and then every 2 weeks (ii) SK 300 mg s.c. loading phase and then monthly (iii) SK 150 mg s.c. loading phase and then monthly (iv) Placebo s.c. loading phase and then every 2 weeks
(i) No major differences in mean change in vitreous haze from baseline to week 28 in all groups (ii) ISM score 0.0 for all SK groups, 1.83 for placebo (iii) No loss in BCVA in all the groups (iv) No apparent dose-response relation for the incidence of AEs (adverse events)
ENDURE Phase III
125
(i) SK 300 mg s.c. loading phase and then every 2 weeks (ii) SK 300 mg s.c. loading phase and then monthly (iii) SK 150 mg s.c. loading phase and then monthly (iv) Placebo s.c. loading phase and then every 2 weeks
(i) No statistically significant differences between all the groups in the time of first recurrence of uveitis (ii) Composite ISM score is similar across all the groups
(i) Intravitreal sirolimus: 325 g at days 0, 60, and 120 (ii) Subconjunctival injection: 1320 g at days 0, 60, and 120
(i) Did not find statistically significant differences between the two study groups at month 6 (ii) improvement of two steps or more of vitreous haze in 40% of the patients
SAVE-2 Phase II
30
(i) Intravitreal sirolimus 440 g at baseline and months 1, 2, 3, 4, and 5 and then prn after month 6 (ii) Intravitreal sirolimus 880 g at baseline and months 2 and 4 and then prn after month 6
Recruiting
SAKURA Phase III
500
(i) Sirolimus low dose (44 g) intravitreal (ii) Sirolimus medium dose (440 g) intravitreal (iii) Sirolimus high dose (880 g) intravitreal
(i) By day 28, 40 patients (60%) achieved an anterior chamber cell score of zero (ii) 1.6 mA-min was the most effective dose (iii) Intraocular pressure and BCVA remained stable throughout the study
(i) Tocilizumab 4 mg IV, 6 monthly doses, and then prn after month 6 (ii) Tocilizumab 8 mg IV 6 monthly doses, and then prn after month 6
Recruiting
Sarilumab
Study to Analyze Sarilumab in Noninfectious Uveitis Phase II
57
(i) Sarilumab s.c. every 2 weeks up to 50 weeks (ii) Placebo s.c. every 2 weeks up to 50 weeks (iii) In both groups prednisone as single therapy or in combination with methotrexate are continued