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Ophthalmology. 2018 Oct 11. pii: S0161-6420(18)30474-3. doi: 10.1016/j.ophtha.2018.09.044. [Epub ahead of print]

Efficacy and Safety of Sarilumab for Noninfectious Uveitis of Posterior Segment: Outcomes From the Phase 2 SATURN Trial.

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Department of Ophthalmology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
Texas Retina Associates, Arlington, TX, USA.
MIOS Retina and Inflammation, Lausanne, Switzerland.
Cleveland Clinic, Cleveland, OH, USA.
Department of Ophthalmology, The University Hospital Brno, Czech Republic.
Department of Ophthalmology, University Hospital of Bellvitge Barcelona University, Spain.
Hacettepe University Medical School, Ankara, Turkey.
İstanbul University Cerrahpaşa Medical School, Istanbul, Turkey.
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Sanofi, Bridgewater, NJ, USA.
Byers Eye Institute, Stanford University, Palo Alto, CA, USA. Electronic address:



To assess efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for the treatment of noninfectious uveitis (NIU) of posterior segment.


Randomized, double-masked, placebo-controlled, phase 2 study.


Fifty-eight patients (eyes) with noninfectious intermediate, posterior, or pan-uveitis.


Eyes were randomized 2:1 to treatment q2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo.


Primary endpoint 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 <10 mg/day at week 16. Primary endpoint was based on VH evaluation by a central reading center. Investigator evaluation of VH was a prespecified, planned secondary analysis.


At week 16, the proportion of sarilumab and placebo patients with ≥2-step reduction in VH or corticosteroid dose <10 mg/day was, respectively, 46.1% versus 30.0% (P=0.2354) based on central reading center assessment of VH, and 64.0% versus 35.0% (P=0.0372) based on investigator assessment of VH. In the subgroup of eyes with VH ≥grade 2 at baseline, the mean VH reduction from baseline to week 16 was significantly greater with sarilumab versus placebo regardless of assessment by central reading center (-2.1 [n=11] versus -1.7 [n=3], respectively; P=0.0255) or investigator (-2.5 [n=19] versus -1.2 [n=11], respectively; P=0.0170). The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab versus placebo in the overall population (8.9 versus 3.6 letters, respectively; P=0.0333) and in the subgroup of eyes with central subfield thickness (CST) ≥300 μm at baseline (12.2 [n=13] versus 2.1 [n=7] letters, respectively; P=0.0517). Corresponding changes in CST were -46.8 versus +2.6 μm (P=0.0683) in the overall population and -112.5 [n=13] versus -1.8 [n=6] μm (P=0.1317) in the subgroup of eyes with CST ≥300 μm 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).


Subcutaneous sarilumab may provide clinical benefits in the management of NIU of the posterior segment, especially in eyes with uveitic macular edema.


Anti-IL-6 receptor antibody; biologic treatment; intraocular inflammation; macular edema; noninfectious; posterior segment intraocular inflammation; sarilumab; uveitis

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