September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Interim results from the SATURN Study: Sarilumab in Non-infectious Uveitis (SARIL-NIU)
Author Affiliations & Notes
  • Quan Dong Nguyen
    Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska, United States
  • Preethi A Sundaram
    Sanofi, Bridgewater, New Jersey, United States
  • Kristine Erickson
    Regeneron Pharmaceuticals , Tarrytown, New York, United States
  • Rafael Varona
    Sanofi, Bridgewater, New Jersey, United States
  • Laetitia Vinet
    Sanofi, Bridgewater, New Jersey, United States
    IT&M Stats, Paris, France
  • Valerie Corp-dit-Genti
    Sanofi, Bridgewater, New Jersey, United States
  • Robert Vitti
    Regeneron Pharmaceuticals , Tarrytown, New York, United States
  • Marc D de Smet
    MIOS, Lausanne, Switzerland
  • Footnotes
    Commercial Relationships   Quan Dong Nguyen, Regeneron (F), Sanofi (F); Preethi Sundaram, Sanofi (E); Kristine Erickson, Regeneron (E); Rafael Varona, Sanofi (E); Laetitia Vinet, IT&M Stats (E), Sanofi (C); Valerie Corp-dit-Genti, Sanofi (E); Robert Vitti, Regeneron (E); Marc de Smet, Sanofi (F)
  • Footnotes
    Support  Sanofi, Inc.
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 1894. doi:
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      Quan Dong Nguyen, Preethi A Sundaram, Kristine Erickson, Rafael Varona, Laetitia Vinet, Valerie Corp-dit-Genti, Robert Vitti, Marc D de Smet; Interim results from the SATURN Study: Sarilumab in Non-infectious Uveitis (SARIL-NIU). Invest. Ophthalmol. Vis. Sci. 2016;57(12):1894.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Interleukin-6 (IL-6) and its soluble receptor are detected in the vitreous and aqueous humors of patients with uveitis. An exploratory study was conducted to evaluate the efficacy and safety of sarilumab, a fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex in the management of posterior non-infectious uveitis (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 SQ every 2 weeks in patients with posterior NIU, who are treated with systemic steroids (Figure 1). The primary endpoint is the proportion of patients with at least 2-step reduction in vitreous haze (VH) in the study eye or a dose of systemic corticosteroid <10 mg/day at week16. Other key endpoints assessed at week 16 included the change from baseline in: VH, macular edema, and best-corrected visual acuity (BCVA).

Results : 58 patients were randomized to sarilumab or matching placebo (2:1). Patient demographics and baseline disease characteristics were balanced between groups (Table 1). The Principal Treatment Period (Part A–Week16) has been completed; Parts B and C are ongoing. At week 16, the combined estimate of proportion of patients with a ≥2-step reduction in VH or steroid dose <10 mg/day was significantly higher in the Sarilumab group vs. placebo when VH was assessed by the Investigator (64.0% vs 35.0%; p=0.0372) and numerically higher when measured by a reading center (46.1% vs 30.0%; p=0.2354). Secondary outcomes at week 16 included a greater mean change in VH score (per reading center) in the sarilumab group vs placebo (LS mean difference: [-0.74(SE: 0.286); p=0.0127; [90%CI:(-1.223 to -0.262)] and improved BCVA [(8.51 vs 3.87 ETDRS letters; LS mean difference: 4.65 (SE: 2.118); p=0.0333; 90%CI: (1.091 to 8.201)]. Serious adverse events were reported in 2 Sarilumab patients (neutropenia [2.6%] and abortion induced [2.6%]) and 1 placebo patient (having both staphylococcal sepsis and deep vein thrombosis [5.0%]) No deaths were reported.

Conclusions : The SATURN study has provided evidence that inhibition of IL-6 signaling may be efficacious in the management of posterior segment NIU. The study is ongoing and results at week 52 are pending.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

 

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