Sarilumab for the treatment of posterior segment non-infectious uveitis (NIU): The SATURN (SARIL-NIU) study
Abstract
Purpose
Interleukin-6 (IL-6) and/or its soluble receptor are detected in the vitreous and aqueous humors of patients with uveitis. Inhibition of IL-6 signaling in a murine model of experimental autoimmune uveitis suppresses the development of uveitis. We designed an exploratory Phase 2 study to evaluate the efficacy and safety of sarilumab, a human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex in the management of posterior segment NIU.
Methods
SATURN is a 52-week, multicenter, double-masked, placebo-controlled, parallel arm, randomized trial to evaluate the efficacy and safety of sarilumab (200 mg) administered subcutaneously every 2 weeks in patients with posterior NIU, who are treated with systemic steroids (as single therapy or with methotrexate). Efficacy and safety are assessed at each visit. The study primary endpoints are reduction from baseline in vitreous haze or systemic-steroid sparing effects, both measured at week 16. Other key endpoints assessed at week 16 include the change from baseline in: central retinal thickness, best-corrected visual acuity, and percentage of patients with retinal vessel leakage on fluorescein angiography.
Results
The study has completed enrollment. As of April 6, 2015, 58 patients have been randomized and treated.
Conclusions
The SATURN study may help clarify the role of IL-6 in the pathogenesis of NIU and the potential for IL-6 inhibition in the management of posterior segment NIU.
