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. 2019 May 24;6:104. doi: 10.3389/fmed.2019.00104

Table 1.

Individual studies' characteristics.

Study Type of study Population Intervention Control Main outcomes Concomitant immunosuppressive drugs Pre-specified maximum duration Observations
Foster Single-centre, double-masked, randomized, placebo-controlled phase 3 trial Adults patients with recurrent uveitis and under a low dosage (≤0.15 mg/kg per week) of MTX for at least 12 weeks with control of uveitis Subcutaneous etanercept 25 mg twice a week Matched placebo administered by the same route and frequency of the intervention Control of inflammation, VA and adverse events No 24 weeks All patients had a mandatory tapering of MTX at 2.5 mg/week starting at 2 weeks after the 1st dose of study medication
VISUAL I Multi-center, double-masked, randomized, placebo-controlled phase 3 trial Adult patients with the diagnosis of active non-infectious intermediate uveitis, posterior uveitis or panuveitis despite oral steroids for 2 or more weeks Subcutaneous adalimumab (loading dose of 80 mg followed by a dose of 40 mg eow) TTF occurring at or after week 6 (a multicomponent outcome that was based on assessment of new inflammatory lesions, best corrected visual acuity, anterior chamber cell grade and vitreous haze grade Participants allowed to receive up to one conventional immunosuppressive drugs at pre-specified doses 80 weeks or when a pre-specified number of TF occurred All patients received a mandatory oral prednisone burst followed by tapering of prednisone over the course of 15 weeks
VISUAL II Multi-center, double-masked, randomized, placebo-controlled phase 3 trial Adult patients with inactive, non-infectious intermediate, posterior or panuveitis uveitis controlled by 10–35 mg/day prednisone Subcutaneous adalimumab (loading dose of 80 mg followed by a dose of 40 mg eow) TTF (a multicomponent outcome based on assessment of new inflammatory lesions, best corrected VA, anterior chamber cell grade and vitreous haze grade) 80 weeks or when a pre-specified number of TF occurred All patients had a mandatory prednisone taper from week 2

MTX, methotrexate; eow, every other week; VA, visual acuity; TTF, time to treatment failure; TF, treatment failure.