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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.

Author information

1
Department of Ophthalmology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
2
Texas Retina Associates, Arlington, TX, USA.
3
MIOS Retina and Inflammation, Lausanne, Switzerland.
4
Cleveland Clinic, Cleveland, OH, USA.
5
Department of Ophthalmology, The University Hospital Brno, Czech Republic.
6
Department of Ophthalmology, University Hospital of Bellvitge Barcelona University, Spain.
7
Hacettepe University Medical School, Ankara, Turkey.
8
İstanbul University Cerrahpaşa Medical School, Istanbul, Turkey.
9
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
10
Sanofi, Bridgewater, NJ, USA.
11
Byers Eye Institute, Stanford University, Palo Alto, CA, USA. Electronic address: ndquan@stanford.edu.

Abstract

PURPOSE:

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

DESIGN:

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

PARTICIPANTS:

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

METHODS:

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

MAIN OUTCOME MEASURES:

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.

RESULTS:

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).

CONCLUSIONS:

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

KEYWORDS:

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

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