June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
The SATURN Study (SARIL-NIU): Sarilumab for the Treatment of Posterior Segment Non-Infectious Uveitis (NIU)
Author Affiliations & Notes
  • Quan Dong Nguyen
    Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE
  • Preethi A Sundaram
    Sanofi, Paris, France
  • Kristine Erickson
    Regeneron Pharmaceuticals, Tarrytown, NY
  • Rafael varona
    Sanofi, Paris, France
  • David Drouot
    Sanofi, Paris, France
  • Valerie Corp-dit-Genti
    Sanofi, Paris, France
  • Husain Kazmi
    Regeneron Pharmaceuticals, Tarrytown, NY
  • Robert Vitti
    Regeneron Pharmaceuticals, Tarrytown, NY
  • Marc D de Smet
    MIOS, Lausanne, Switzerland
  • Footnotes
    Commercial Relationships Quan Dong Nguyen, Genentech (F), Psivida (F), Regeneron (F), Sanofi (F), XOMA (F); Preethi Sundaram, Sanofi (E); Kristine Erickson, Regeneron Pharmaceuticals (E); Rafael varona, Sanofi (E); David Drouot, Sanofi (E); Valerie Corp-dit-Genti, Sanofi (E); Husain Kazmi, Regeneron Pharmaceuticals (E); Robert Vitti, Regeneron Pharmaceuticals (E); Marc de Smet, Regeneron Pharmaceuticals (C), Sanofi (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 3116. doi:
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      Quan Dong Nguyen, Preethi A Sundaram, Kristine Erickson, Rafael varona, David Drouot, Valerie Corp-dit-Genti, Husain Kazmi, Robert Vitti, Marc D de Smet, ; The SATURN Study (SARIL-NIU): Sarilumab for the Treatment of Posterior Segment Non-Infectious Uveitis (NIU) . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3116.

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

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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 study 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 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 and 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 retinal vessel leakage on fluorescein angiography. A graphical representation of the study design is presented in the Figure below.

 
Results
 

The study is ongoing. As of 29 October 2014, 33 of 57 patients have been randomized and treated; 19 subjects have completed the Principal Treatment Period (Part A). Baseline demographic and disease characteristics are presented in the Table below.

 
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.  

 
SATURN study: Graphical Study Design
 
SATURN study: Graphical Study Design
 

 
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