Efficacy and Safety of Sarilumab for the Treatment of Posterior Segment Noninfectious Uveitis (SARIL-NIU): The Phase 2 SATURN Study
Abstrakt
Purpose: To assess efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for treatment of posterior segment noninfectious uveitis (NIU). Design: Randomized, double-masked, placebo-controlled, phase 2 study.
Participants: Fifty-eight patients (eyes) with noninfectious intermediate, posterior, or panuveitis. Methods: Eyes received treatment every 2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo.
Main Outcome Measures: The primary end point was the proportion of patients with >= 2-step reduction in vitreous haze (VH) on the Miami scale or with a reduction of systemic corticosteroids (prednisolone or equivalent) to a dose of = 2-step reduction in VH or corticosteroid dose = 2 at baseline, the mean VH reduction from baseline to week 16 was significantly greater with sarilumab vs. placebo regardless of assessment by the central reading center (-2.1 [n = 11] vs. -1.7 [n = 3], respectively; P = 0.0255) or investigator (-2.5 [n = 19] vs. -1.2 [n = 11], respectively; P = 0.0170). The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab vs. placebo in the overall population (8.9 vs. 3.6 letters, respectively; P = 0.0333) and in the subgroup of eyes with central subfield thickness (CST) >= 300 mu m at baseline (12.2 [n = 13] vs. 2.1 [n = 7] letters, respectively; P = 0.0517).
Corresponding changes in CST were -46.8 vs. +2.6 mu m (P = 0.0683) in the overall population and -112.5 [n = 13] vs. -1.8 [n = 6] mu m (P = 0.1317) in the subgroup of eyes with CST >= 300 mu m at baseline, respectively. The most common ocular adverse events were worsening of uveitis (0 [placebo] and 3 [sarilumab] patients) and retinal infiltrates (1 [placebo] and 2 [sarilumab] patients).
Conclusions: Subcutaneous sarilumab may provide clinical benefits in the management of NIU of the posterior segment, especially in eyes with uveitic macular edema.