PURPOSE To assess efficacy and safety of sarilumab, a human anti-interleukin-6 receptor antibody, for treatment of posterior segment noninfectious uveitis (NIU). DESIGN Randomized, double-masked, placebo-controlled, phase 2 study. PARTICIPANTS Fifty-eight patients (eyes) with noninfectious intermediate, posterior, or panuveitis. METHODS Eyes received treatment every 2 weeks for 16 weeks with subcutaneous sarilumab 200 mg or placebo. MAIN OUTCOME MEASURES The primary end point 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 end point was based on VH evaluation by a central reading center. Investigator evaluation of VH was a prespecified, planned secondary analysis. RESULTS At week 16, proportion of patients taking sarilumab or placebo with ≥2-step reduction in VH or corticosteroid dose <10 mg/day was 46.1% vs. 30.0% (P = 0.2354) based on central reading center assessment of VH and 64.0% vs. 35.0% (P = 0.0372) based on investigator assessment of VH, respectively. 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 vs. placebo regardless of assessment by the central reading center (-2.1 [n = 11] vs. -1.7 [n = 3], respectively; P = 0.0255) or investigator (-2.5 [n = 19] vs. -1.2 [n = 11], respectively; P = 0.0170). The mean best-corrected visual acuity gain from baseline to week 16 was greater with sarilumab vs. placebo in the overall population (8.9 vs. 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] vs. 2.1 [n = 7] letters, respectively; P = 0.0517). Corresponding changes in CST were -46.8 vs. +2.6 μm (P = 0.0683) in the overall population and -112.5 [n = 13] vs. -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.

中文翻译：

---

Sarilumab治疗后段非感染性葡萄膜炎（SARIL-NIU）的功效和安全性：SATURN 2期研究。

目的评估人抗白细胞介素6受体抗体sarilumab治疗后段非感染性葡萄膜炎（NIU）的疗效和安全性。设计随机，双掩蔽，安慰剂对照的2期研究。参与者58例非感染性中间，后或胰腺炎患者（眼睛）。方法每两周对眼睛进行200周皮下注射sarilumab 200 mg或安慰剂治疗，持续16周。主要观察指标主要终点是在迈阿密范围内玻璃体雾度（VH）≥2步降低或全身性皮质类固醇（泼尼松龙或同等剂量）降低至<10 mg /天的患者比例第16周，主要终点基于中央阅读中心的VH评估。VH的研究者评估是预先确定的，计划中的二次分析。结果在第16周时，根据中央阅读中心对VH和64.0的评估，服用sarilumab或安慰剂且VH≥2步降低或皮质类固醇剂量<10 mg /天的患者比例为46.1％，而同期为30.0％（P = 0.2354）。分别根据VH的研究人员评估得出的百分比对35.0％（P = 0.0372）。在基线时VH≥2的亚组眼中，无论中央阅读中心如何评估，使用sarilumab与安慰剂相比，从基线到第16周的平均VH降低幅度明显更大（-2.1 [n = 11]与-1.7分别为[n = 3]； P = 0.0255）或研究者（分别为-2.5 [n = 19]和-1.2 [n = 11]； P = 0.0170）。sarilumab与安慰剂相比，从基线到第16周的平均最佳矫正视力增益在总人群中更高（分别为8.9个字母和3.6个字母； P = 0。0333）和在基线时中心子场厚度（CST）≥300μm的眼睛亚组（分别为12.2 [n = 13]个字母和2.1 [n = 7]个字母； P = 0.0517）。眼睛亚群中相应的CST变化为-46.8 vs. + 2.6μm（P = 0.0683），而在眼睛亚组中，CST的变化为-112.5 [n = 13] vs -1.8 [n = 6]μm（P = 0.1317）。基线处的CST≥300μm。最常见的眼部不良事件是葡萄膜炎（0例安慰剂和3例sarilumab）和视网膜浸润（1例安慰剂和2例sarilumab）。结论sarilumab皮下注射可为后段NIU的治疗提供临床益处，尤其是葡萄膜黄斑水肿的眼睛。眼睛亚群中相应的CST变化为-46.8 vs. + 2.6μm（P = 0.0683），而在眼睛亚组中，CST的变化为-112.5 [n = 13] vs -1.8 [n = 6]μm（P = 0.1317）。基线处的CST≥300μm。最常见的眼部不良事件是葡萄膜炎（0例安慰剂和3例sarilumab）和视网膜浸润（1例安慰剂和2例sarilumab）。结论皮下注射sarilumab可为后段NIU的治疗提供临床益处，尤其是在葡萄膜黄斑水肿的眼睛中。眼睛亚群中相应的CST变化为-46.8 vs. + 2.6μm（P = 0.0683），而在眼睛亚组中，CST的变化为-112.5 [n = 13] vs -1.8 [n = 6]μm（P = 0.1317）。基线处的CST≥300μm。最常见的眼部不良事件是葡萄膜炎（0例安慰剂和3例sarilumab）和视网膜浸润（1例安慰剂和2例sarilumab）。结论sarilumab皮下注射可为后段NIU的治疗提供临床益处，尤其是葡萄膜黄斑水肿的眼睛。最常见的眼部不良事件是葡萄膜炎（0例安慰剂和3例sarilumab）和视网膜浸润（1例安慰剂和2例sarilumab）。结论sarilumab皮下注射可为后段NIU的治疗提供临床益处，尤其是葡萄膜黄斑水肿的眼睛。最常见的眼部不良事件是葡萄膜炎（0例安慰剂和3例sarilumab）和视网膜浸润（1例安慰剂和2例sarilumab）。结论sarilumab皮下注射可为后段NIU的治疗提供临床益处，尤其是葡萄膜黄斑水肿的眼睛。